PENTAX ED-3490TK (UDI 04961333229611)Recalls & reported problems

Summary

The FDA's MAUDE database contains 43 adverse event reports that list this exact device (DI 04961333229611), received between Jul 22, 2020 and Jun 21, 2021 — classified as 43 malfunctions.

The most frequently reported specific device problem is “Loss of or Failure to Bond” (41 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 43 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 21, 2021Loss of or Failure to Bond; Loss of or Failure to Bond

  PENTAX OF AMERICA INITIATED FIELD CORRECTION 2017-001-C WHICH INCLUDED INSPECTION OF THE SEAL AROUND THE DISTAL BODY AND DISTAL CAP OF THE ED-3490TK DUODENOSCOPE PURSUANT TO PREDEFINED INSPECTION CRITERIA (ET-HF-P-0013 REV. 00). THE OBJECTIVE OF THE INSPECTION WAS TO VERIFY THERE WERE NO DEFECTS/DISCONTINUITIES IN THE SEAL BETWEEN THE DISTAL BODY AND DISTAL CAP. THE INSPECTIONAL CRITERIA WAS DEFINED AS, "ALL SEAL SURFACES OBSERVED SHALL BE CONTINUOUS AND SMOOTH WITH NO OUTWARD SIGNS OF DISCONTINUITY, GAPS OR BUBBLES." A DEVICE WAS CONSIDERED TO FAIL THE INSPECTION IF ANY ELEMENT OF THE CRITERIA WAS NOT MET. THE CUSTOMER OWNED DEVICE WAS PREVIOUSLY RETURNED TO PENTAX MEDICAL FROM A CUSTOMER ON 24-MAY-2021 AND INSPECTION OF THE UNIT WAS PERFORMED UNDER SERVICE ORDER (B)(4) WHERE THE QUALITY CONTROL INSPECTOR DOCUMENTED THE FOLLOWING CODES ON 24-MAY-2021: DISTAL CAP - FIXED TYPE FAILED SEAL INTEGRITY INSPECTION, INSERTION TUBE BUMP AT STAGE 1, PRISM SCRATCHED, HOLE IN # 4 REMOTE CONTROL BUTTON COVER, DISTAL CAP - FIXED TYPE DISTAL TIP UPGRADE, BENDING RUBBERSEVERE DISCOLORATION, IMAGE SHADOWS, PASSED WET LEAK TEST, PASSED DRY LEAK TEST, LIGHT CARRYING BUNDLE DISTAL COVER, GLASS MIDDLE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12033395 ↗
• MalfunctionJun 21, 2021Loss of or Failure to Bond; Loss of or Failure to Bond

  PENTAX OF AMERICA INITIATED FIELD CORRECTION 2017-001-C WHICH INCLUDED INSPECTION OF THE SEAL AROUND THE DISTAL BODY AND DISTAL CAP OF THE ED-3490TK DUODENOSCOPE PURSUANT TO PREDEFINED INSPECTION CRITERIA (ET-HF-P-0013 REV. 00). THE OBJECTIVE OF THE INSPECTION WAS TO VERIFY THERE WERE NO DEFECTS/DISCONTINUITIES IN THE SEAL BETWEEN THE DISTAL BODY AND DISTAL CAP. THE INSPECTIONAL CRITERIA WAS DEFINED AS, "ALL SEAL SURFACES OBSERVED SHALL BE CONTINUOUS AND SMOOTH WITH NO OUTWARD SIGNS OF DISCONTINUITY, GAPS OR BUBBLES." A DEVICE WAS CONSIDERED TO FAIL THE INSPECTION IF ANY ELEMENT OF THE CRITERIA WAS NOT MET. THE RENTED ENDOSCOPE WAS PREVIOUSLY RETURNED TO PENTAX MEDICAL FROM A CUSTOMER ON 14-JUN-2021 AND INSPECTION OF THE UNIT WAS PERFORMED UNDER SERVICE ORDER (B)(4) WHERE THE QUALITY CONTROL INSPECTOR DOCUMENTED THE FOLLOWING CODES ON 15-JUN-2021: DISTAL CAP - FIXED TYPE FAILED SEAL INTEGRITY INSPECTION, INSERTION TUBE GAUGE/DIG AT STAGE 1, CONTROL BODY ROOT BRACE CUT, PRISM SCRATCHED, AIR/ WATER SOCKET CYLINDER O-RING CHIPPED, PRIMARY OPERATION CHANNEL RESISTANCE, DISTAL CAP/ CASE SCRATCHED, MIDDLE LCB DISTAL COVER GLASS GLUE IS MISSING, FAILED WET LEAK TEST, SUCTION TUBE RESISTAN

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12033343 ↗
• MalfunctionJun 16, 2021Loss of or Failure to Bond; Loss of or Failure to Bond

  THE LOANER DEVICE WAS PREVIOUSLY RETURNED TO PENTAX MEDICAL FROM A CUSTOMER ON 11-DEC-2019 AND INSPECTION OF THE UNIT WAS PERFORMED UNDER SERVICE ORDER (B)(4) WHERE THE QUALITY CONTROL INSPECTOR DOCUMENTED THE FOLLOWING CODES ON 18-MAY-2021: DISTAL CAP - FIXED TYPE FAILED EPOXY SEAL INTEGRITY INSPECTION, DISTAL CAP/ CASE CRACKED, DISTAL TIP ANNUAL MAINTENANCE, AIR/ WATER SOCKET CYLINDER O-RING CHIPPED, PASSED WET LEAK TEST, PASSED DRY LEAK TEST, PRISM GLASS GLUE MISSING. THE DUODENOSCOPE'S REPAIRS WILL INCLUDE THE DISTAL CASE/CAP, WHICH WILL BE REPLACED AND/OR RESEALED PURSUANT TO THE FIELD CORRECTION, ALONG WITH THE FOLLOWING PARTS PARTS, AND RETURNED TO THE USER UPON COMPLETION: O-RING(0.5X1.3) IMP-1 MODEL ED-3490TK, SERIAL NUMBER (B)(4), HAS BEEN ROUTINELY SERVICED AT A PENTAX FACILITY SINCE THE DEVICE WAS PUT INTO SERVICE ON 11-OCT-2018. THE ENDOSCOPE WAS APPROVAL BY FINAL QC ON 15 -JUN-2021 AND WAS PUT BACK INTO LOANER INVENTORY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12012360 ↗
• MalfunctionJun 16, 2021Loss of or Failure to Bond; Loss of or Failure to Bond

  THE LOANER DEVICE WAS PREVIOUSLY RETURNED TO PENTAX MEDICAL FROM A CUSTOMER ON (B)(6) 2019 AND INSPECTION OF THE UNIT WAS PERFORMED UNDER SERVICE ORDER (B)(4) WHERE THE QUALITY CONTROL INSPECTOR DOCUMENTED THE FOLLOWING CODES ON (B)(6) 2021: DISTAL CAP - FIXED TYPE FAILED EPOXY SEAL INTEGRITY INSPECTION, PASSED DRY LEAK TEST, PASSED WET LEAK TEST, DEFLECTOR LINK PIVOT O-RING REPLACEMENT FOR ANNUAL MAINTENAN. THE DUODENOSCOPE'S REPAIRS WILL INCLUDE THE DISTAL CASE/CAP, WHICH WILL BE REPLACED AND/OR RESEALED PURSUANT TO THE FIELD CORRECTION, ALONG WITH THE FOLLOWING PARTS, AND RETURNED TO THE USER UPON COMPLETION: O-RING(0.5X1.3) IMP-1 MODEL ED-3490TK, SERIAL NUMBER (B)(4), HAS BEEN ROUTINELY SERVICED AT A PENTAX FACILITY SINCE THE DEVICE WAS PUT INTO SERVICE ON (B)(6) 2011. THE ENDOSCOPE WAS APPROVAL BY FINAL QC ON 09 -JUN-2021 AND WAS PUT BACK INTO LOANER INVENTORY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12012296 ↗
• MalfunctionJun 16, 2021Loss of or Failure to Bond; Loss of or Failure to Bond

  THE CUSTOMER OWNED DEVICE WAS PREVIOUSLY RETURNED TO PENTAX MEDICAL FROM A CUSTOMER ON 20-MAY-2021 AND INSPECTION OF THE UNIT WAS PERFORMED UNDER SERVICE ORDER (B)(4) WHERE THE QUALITY CONTROL INSPECTOR DOCUMENTED THE FOLLOWING CODES ON 21-MAY-2021: DISTAL CAP - FIXED TYPE FAILED EPOXY SEAL INTEGRITY INSPECTON, INSERTION TUBE BUMP AT END OF ROOT BRACE, IMAGE SPOTS, DISTAL CAP/ CASE CRACKED, PRIMARY OPERATION CHANNEL RESISTANCE, BENDING RUBBERSEVERE DISCOLORATION, MIDDLE LCB DISTAL COVER GLASS GLUE IS MISSING, FAILED DRY LEAK TEST, SUCTION TUBE RESISTANCE, SEGMENT STEEL BRAID LOOSE, UMBILICAL CABLE BUCKLE AT UMBILICAL CONNECTOR SIDE, FAILED WET LEAK TEST, LEAK AT BIOPSY CHANNEL (LARGE/ PRIMARY) DISTAL SIDE, LIGHT CARRYING BUNDLE DISTAL COVER GLASS MIDDLE CHIPPED, PRISM SCRATCHED, DISTAL TIP ANNUAL MAINTENANCE. THE DUODENOSCOPE'S REPAIRS WILL INCLUDE THE DISTAL CASE/CAP, WHICH WILL BE REPLACED AND/OR RESEALED PURSUANT TO THE FIELD CORRECTION, ALONG WITH THE FOLLOWING PARTS, AND RETURNED TO THE USER UPON COMPLETION: O-RINGS AND SEALS, AIR/WATER TUBE, DEFLECTOR OPERATING WIRE, DEFLECTOR STAYCOIL, LCB DISTAL COVER, OBJECTIVE PRISM ASSY, OPERATION CHANNEL, ADJUSTING COLLAR, BENDING RUBBE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12012207 ↗
• MalfunctionJun 9, 2021Loss of or Failure to Bond; Loss of or Failure to Bond

  THE LOANER DEVICE WAS PREVIOUSLY RETURNED TO PENTAX MEDICAL FROM A CUSTOMER ON (B)(6)2021 AND INSPECTION OF THE UNIT WAS PERFORMED UNDER SERVICE ORDER (B)(4) WHERE THE QUALITY CONTROL INSPECTOR DOCUMENTED THE FOLLOWING CODES ON (B)(6) 2021: DISTAL CAP - FIXED TYPE FAILED EPOXY SEAL INTEGRITY INSPECTION, DISTAL CAP/ CASE CRACKED, PASSED DRY LEAK TEST, PASSED WET LEAK TEST, MIDDLE LCB DISTAL COVER GLASS GLUE IS MISSING, OPERATION CHANNEL- PRIMARY MILD RESISTANCE. THE DUODENOSCOPE'S REPAIRS WILL INCLUDE THE DISTAL CASE/CAP, WHICH WILL BE REPLACED AND/OR RESEALED PURSUANT TO THE FIELD CORRECTION, ALONG WITH THE FOLLOWING PARTS, AND RETURNED TO THE USER UPON COMPLETION: O-RING(0.5X1.3) IMP-1. MODEL ED-3490TK, SERIAL NUMBER (B)(4), HAS BEEN ROUTINELY SERVICED AT A PENTAX FACILITY SINCE THE DEVICE WAS PUT INTO SERVICE ON (B)(6) 2016. THE ENDOSCOPE IS AWAITING REPAIR OR APPROVAL BY FINAL QC AS OF (B)(6) 2021.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11967532 ↗
• MalfunctionJun 9, 2021Loss of or Failure to Bond; Loss of or Failure to Bond

  THE LOANER DEVICE WAS PREVIOUSLY RETURNED TO PENTAX MEDICAL FROM A CUSTOMER ON 31-AUG-2020 AND INSPECTION OF THE UNIT WAS PERFORMED UNDER SERVICE ORDER (B)(4) WHERE THE QUALITY CONTROL INSPECTOR DOCUMENTED THE FOLLOWING CODES ON 12-MAY-2021: DISTAL CAP - FIXED TYPE FAILED EPOXY SEAL INTEGRITY INSPECTION, DISTAL TIP ANNUAL MAINTENANCE, PASSED DRY LEAK TEST, MIDDLE LCB DISTAL COVER GLASS GLUE IS MISSING, PASSED WET LEAK TEST, PRISM GLASS GLUE MISSING. THE DUODENOSCOPE'S REPAIRS WILL INCLUDE THE DISTAL CASE/CAP, WHICH WILL BE REPLACED AND/OR RESEALED PURSUANT TO THE FIELD CORRECTION, ALONG WITH THE FOLLOWING PARTS PARTS, AND RETURNED TO THE USER UPON COMPLETION: O-RING(0.5X1.3) IMP-1 MODEL ED-3490TK, SERIAL NUMBER (B)(4), HAS BEEN ROUTINELY SERVICED AT A PENTAX FACILITY SINCE THE DEVICE WAS PUT INTO SERVICE ON 01-AUG-2016. THE ENDOSCOPE IS AWAITING REPAIR OR APPROVAL BY FINAL QC AS OF 09-JUN-2021.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11967406 ↗
• MalfunctionMay 17, 2021Loss of or Failure to Bond; Loss of or Failure to Bond

  THE CUSTOMER OWNED DEVICE WAS PREVIOUSLY RETURNED TO PENTAX MEDICAL FROM A CUSTOMER ON 05-MAY-2021 AND INSPECTION OF THE UNIT WAS PERFORMED UNDER SERVICE ORDER (B)(4) WHERE THE QUALITY CONTROL INSPECTOR DOCUMENTED THE FOLLOWING CODES ON 06-MAY-2021: DISTAL CAP - FIXED TYPE FAILED EPOXY SEAL INTEGRITY INSPECTION, UMBILICAL CABLE BUCKLE AT UMBILICAL CONNECTOR SIDE, DISTAL CAP/ CASE CRACKED, DISTAL TIP ANNUAL MAINTENANCE, IMAGE BLACKOUT, PASSED WET LEAK TEST, PASSED DRY LEAK TEST, PRISM GLASS GLUE MISSING, SUCTION TUBE TWISTED/KINK, OPERATION CHANNEL- PRIMARY MILD RESISTANCE. THE DUODENOSCOPE'S REPAIRS WILL INCLUDE THE DISTAL CASE/CAP, WHICH WILL BE REPLACED AND/OR RESEALED PURSUANT TO THE FIELD CORRECTION, ALONG WITH THE FOLLOWING PARTS, AND RETURNED TO THE USER UPON COMPLETION: O-RINGS AND SEALS, SUCTION CHANNEL LG, LIGHT GUIDE CABLE, PCB FOR CCD K2 PB-FREE/NTSC, ELECTRICAL CONNECTOR ASSY, O-RING(0.5X1.3) IMP-1, DISTAL CASE/CAP, O-RING (1.8X19.8). MODEL ED-3490TK, SERIAL NUMBER (B)(4), HAS BEEN ROUTINELY SERVICED AT A PENTAX FACILITY SINCE THE DEVICE WAS PUT INTO SERVICE ON (B)(6) 2013. THE ENDOSCOPE IS AWAITING REPAIR OR APPROVAL BY FINAL QC AS OF 13-MAY-2021.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11836286 ↗
• MalfunctionMay 6, 2021Loss of or Failure to Bond; Loss of or Failure to Bond

  THE CUSTOMER OWNED DEVICE WAS PREVIOUSLY RETURNED TO PENTAX MEDICAL FROM A CUSTOMER ON 14-APR-2021 AND INSPECTION OF THE UNIT WAS PERFORMED UNDER SERVICE ORDER (B)(4) WHERE THE QUALITY CONTROL INSPECTOR DOCUMENTED THE FOLLOWING CODES ON 16-APR-2021: DISTAL CAP - FIXED TYPE FAILED EPOXY SEAL INTEGRITY INSPECTION, BENDING RUBBER PINHOLE, PRISM SCRATCHED, AIR/ WATER SOCKET CYLINDER O-RING CHIPPED, DISTAL CAP/ CASE CRACKED, FAILED WET LEAK TEST, FAILED DRY LEAK TEST, LIGHT CARRYING BUNDLE DISTAL COVER GLASS MIDDLE SCRATCHED, FLUID INVASION NOT OBSERVED IN PVE CONNECTOR, FLUID INVASION NOT OBSERVED IN CONTROL BODY, BENDING RUBBER LEAK AT MIDDLE SECTION. THE DUODENOSCOPE'S REPAIRS WILL INCLUDE THE DISTAL CASE/CAP, WHICH WILL BE REPLACED AND/OR RESEALED PURSUANT TO THE FIELD CORRECTION, ALONG WITH THE FOLLOWING PARTS , AND RETURNED TO THE USER UPON COMPLETION: O-RINGS AND SEALS, LCB DISTAL COVER, OBJECTIVE PRISM ASSY, BENDING RUBBER, DISTAL CASE/CAP, O-RING(0.5X1.3) IMP-1, O-RING (1.8X19.8). MODEL ED-3490TK, SERIAL NUMBER (B)(4) , HAS BEEN ROUTINELY SERVICED AT A PENTAX FACILITY SINCE THE DEVICE WAS PUT INTO SERVICE ON (B)(6) 2016 THE ENDOSCOPE IS AWAITING REPAIR OR APPROVAL BY FINAL QC A

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11783834 ↗
• MalfunctionMay 6, 2021Loss of or Failure to Bond; Loss of or Failure to Bond

  THE CUSTOMER OWNED DEVICE WAS PREVIOUSLY RETURNED TO PENTAX MEDICAL FROM A CUSTOMER ON 23-APR-2021 AND INSPECTION OF THE UNIT WAS PERFORMED UNDER SERVICE ORDER 3132783 WHERE THE QUALITY CONTROL INSPECTOR DOCUMENTED THE FOLLOWING CODES ON 26-APR-2021: DISTAL CAP - FIXED TYPE FAILED EPOXY SEAL INTEGRITY INSPECTION, PRIMARY OPERATION CHANNEL RESISTANCE, DISTAL TIP ANNUAL MAINTENANCE, DISTAL CAP/ CASE CRACKED, IMAGE NOISY, PASSED DRY LEAK TEST, SUCTION TUBE RESISTANCE, SEGMENT STEEL BRAID CUT, CONNECTOR ROOT BRACE CRACKED, LIGHTGUIDE PRONG COVER GLASS SET LOOSE, PASSED WET LEAK TEST, FLUID INVASION NOT OBSERVED IN CONTROL BODY, FLUID INVASION NOT OBSERVED IN PVE CONNECTOR, UMBILICAL CABLE BUMP AT PVE SIDE, SEGMENT COMPRESSED. THE DUODENOSCOPE'S REPAIRS WILL INCLUDE THE DISTAL CASE/CAP, WHICH WILL BE REPLACED AND/OR RESEALED PURSUANT TO THE FIELD CORRECTION, ALONG WITH THE FOLLOWING PARTS PARTS, AND RETURNED TO THE USER UPON COMPLETION: O-RINGS AND SEALS, OPERATION CHANNEL, BENDING RUBBER, DISTAL CASE/CAP, STAYCOIL COLLAR, SEGMENT STAYCOIL ASSY IMP-C/PB-FREE, SUCTION CHANNEL LG, ROOT BRACE RUBBER LG CONNECTOR, PCB FOR CCD K2 PB-FREE/NTSC, ELECTRICAL CONNECTOR ASSY, O-RING(0.5X1.3) IMP-1

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11783830 ↗
• MalfunctionMay 6, 2021Loss of or Failure to Bond; Loss of or Failure to Bond

  THE CUSTOMER OWNED DEVICE WAS PREVIOUSLY RETURNED TO PENTAX MEDICAL FROM A CUSTOMER ON 15-APR-2021 AND INSPECTION OF THE UNIT WAS PERFORMED UNDER SERVICE ORDER (B)(4) WHERE THE QUALITY CONTROL INSPECTOR DOCUMENTED THE FOLLOWING CODES ON 16-APR-2021: DISTAL CAP - FIXED TYPE FAILED EPOXY SEAL INTEGRITY INSPECTION, BENDING RUBBER PINHOLE, DISTAL TIP ANNUAL MAINTENANCE, DISTAL CAP/ CASE CRACKED, BIOPSY INSULATION RING DEFORMED, FAILED WET LEAK TEST, SEGMENT STEEL BRAID CUT, FAILED DRY LEAK TEST, HOLE IN # 2 REMOTE CONTROL BUTTON COVER, OPERATION CHANNEL- PRIMARY MILD RESISTANCE. THE DUODENOSCOPE'S REPAIRS WILL INCLUDE THE DISTAL CASE/CAP, WHICH WILL BE REPLACED AND/OR RESEALED PURSUANT TO THE FIELD CORRECTION, ALONG WITH THE FOLLOWING PARTS, AND RETURNED TO THE USER UPON COMPLETION: O-RINGS AND SEALS, AIR/WATER TUBE, DEFLECTOR OPERATING WIRE, DEFLECTOR STAYCOIL, OPERATION CHANNEL, ADJUSTING COLLAR, BENDING RUBBER, SEGMENT ATTACHING SCREW, DISTAL CASE/CAP, DISTAL CASE ATTACHING SCREW, SEGMENT ASSY ATTACHING SCREW, STAYCOIL COLLAR, SEGMENT STAYCOIL ASSY IMP-C/PB-FREE, INSULATION RING ASSY, RL PULLEY ASSY, UD PULLEY ASSY, O-RING(0.5X1.3) IMP-1. MODEL ED-3490TK, SERIAL NUMBER (B)(4), HAS B

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11783829 ↗
• MalfunctionApr 14, 2021Loss of or Failure to Bond; Loss of or Failure to Bond

  PENTAX OF AMERICA INITIATED FIELD CORRECTION 2017-001-C WHICH INCLUDED INSPECTION OF THE SEAL AROUND THE DISTAL BODY AND DISTAL CAP OF THE ED-3490TK DUODENOSCOPE PURSUANT TO PREDEFINED INSPECTION CRITERIA (ET-HF-P-0013 REV. 00). THE OBJECTIVE OF THE INSPECTION WAS TO VERIFY THERE WERE NO DEFECTS/DISCONTINUITIES IN THE SEAL BETWEEN THE DISTAL BODY AND DISTAL CAP. THE INSPECTIONAL CRITERIA WAS DEFINED AS, "ALL SEAL SURFACES OBSERVED SHALL BE CONTINUOUS AND SMOOTH WITH NO OUTWARD SIGNS OF DISCONTINUITY, GAPS OR BUBBLES." A DEVICE WAS CONSIDERED TO FAIL THE INSPECTION IF ANY ELEMENT OF THE CRITERIA WAS NOT MET. THE CUSTOMER OWNED DEVICE WAS PREVIOUSLY RETURNED TO PENTAX MEDICAL FROM THE CUSTOMER ON 12-MAR-2021 AND INSPECTION OF THE UNIT WAS PERFORMED UNDER SERVICE ORDER (B(4) WHERE THE QUALITY CONTROL INSPECTOR DOCUMENTED THE FOLLOWING CODES ON 15-MAR-2021: DISTAL CAP - FIXED TYPE FAILED SEAL INTEGRITY INSPECTION, PRIMARY OPERATION CHANNEL RESISTANCE, DISTAL CAP - FIXED TYPE DISTAL TIP UPGRADE, HOLE IN # 1 REMOTE CONTROL BUTTON COVER, HOLE IN # 3 REMOTE CONTROL BUTTON COVER, HOLE IN # 4 REMOTE CONTROL BUTTON COVER, PRISM SCRATCHED, FAILED DRY LEAK TEST, IMAGE SHADOWS, FAILED WET LEAK T

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11666038 ↗
• MalfunctionApr 1, 2021Loss of or Failure to Bond; Loss of or Failure to Bond

  THE LOANER DEVICE WAS PREVIOUSLY RETURNED TO PENTAX MEDICAL FROM A CUSTOMER ON 07-NOV-2019 AND INSPECTION OF THE UNIT WAS PERFORMED UNDER SERVICE ORDER (B)(4) WHERE THE QUALITY CONTROL INSPECTOR DOCUMENTED THE FOLLOWING CODES ON 02-MAR-2021: DISTAL CAP - FIXED TYPE FAILED EPOXY SEAL INTEGRITY INSPECTION, PRISM CRACKED, AIR/ WATER NOZZLE CLOGGED, PASSED WET LEAK TEST, PASSED DRY LEAK TEST. THE DUODENOSCOPE'S REPAIRS WILL INCLUDE THE DISTAL CASE/CAP, WHICH WILL BE REPLACED AND/OR RESEALED PURSUANT TO THE FIELD CORRECTION, ALONG WITH THE FOLLOWING PARTS PARTS, AND RETURNED TO THE USER UPON COMPLETION: DISTAL CASE/CAP, O-RING(0.5X1.3) IMP-1, O-RING (1.8X19.8). MODEL ED-3490TK, SERIAL NUMBER (B)(4) , HAS BEEN ROUTINELY SERVICED AT A PENTAX FACILITY SINCE THE DEVICE WAS PUT INTO SERVICE ON (B)(6) 2019. THE ENDOSCOPE IS AWAITING REPAIR OR APPROVAL BY FINAL QC AS OF 01-APR-2021.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11604203 ↗
• MalfunctionApr 1, 2021Loss of or Failure to Bond; Loss of or Failure to Bond

  THE LOANER DEVICE WAS PREVIOUSLY RETURNED TO PENTAX MEDICAL FROM A CUSTOMER ON (B)(6)2019 AND INSPECTION OF THE UNIT WAS PERFORMED UNDER SERVICE ORDER (B)(4) WHERE THE QUALITY CONTROL INSPECTOR DOCUMENTED THE FOLLOWING CODES ON 05-MAR-2021: DISTAL CAP - FIXED TYPE FAILED EPOXY SEAL INTEGRITY INSPECTION, DISTAL CAP/ CASE CRACKED, DISTAL TIP ANNUAL MAINTENANCE, PASSED DRY LEAK TEST, PASSED WET LEAK TEST, HOLE IN # 2 REMOTE CONTROL BUTTON COVER, SUCTION TUBE MILD RESISTANCE. THE DUODENOSCOPE'S REPAIRS WILL INCLUDE THE DISTAL CASE/CAP, WHICH WILL BE REPLACED AND/OR RESEALED PURSUANT TO THE FIELD CORRECTION, ALONG WITH THE FOLLOWING PARTS, AND RETURNED TO THE USER UPON COMPLETION: O-RING(0.5X1.3) IMP-1. MODEL ED-3490TK, SERIAL NUMBER (B)(4), HAS BEEN ROUTINELY SERVICED AT A PENTAX FACILITY SINCE THE DEVICE WAS PUT INTO SERVICE ON 28-APR-2015. THE ENDOSCOPE IS AWAITING REPAIR OR APPROVAL BY FINAL QC AS OF 01-APR-2021.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11604193 ↗
• MalfunctionFeb 19, 2021Loss of or Failure to Bond; Loss of or Failure to Bond

  THE CUSTOMER OWNED DEVICE WAS PREVIOUSLY RETURNED TO PENTAX MEDICAL FROM A CUSTOMER ON 08-FEB-2021 AND INSPECTION OF THE UNIT WAS PERFORMED UNDER SERVICE ORDER (B)(4) WHERE THE QUALITY CONTROL INSPECTOR DOCUMENTED THE FOLLOWING CODES ON 10-FEB-2021: DISTAL CAP - FIXED TYPE FAILED EPOXY SEAL INTEGRITY INSPECTION, OPERATION CHANNEL- PRIMARY BALL TIP DOES NOT PASS, DISTAL TIP ANNUAL MAINTENANCE, FAILED DRY LEAK TEST, LIGHTGUIDE PRONG COVER GLASS SET LOOSE, FAILED WET LEAK TEST, DISTAL CAP/ CASE CRACKED, RIGHT/ LEFT BRAKE KNOB MARKINGS FADED, BENDING RUBBER LEAK AT MIDDLE SECTION, FLUID INVASION NOT OBSERVED IN CONTROL BODY, FLUID INVASION NOT OBSERVED IN PVE CONNECTOR, BENDING RUBBER PINHOLE. THE DUODENOSCOPE'S REPAIRS WILL INCLUDE THE DISTAL CASE/CAP, WHICH WILL BE REPLACED AND/OR RESEALED PURSUANT TO THE FIELD CORRECTION, ALONG WITH THE FOLLOWING PARTS, AND RETURNED TO THE USER UPON COMPLETION: O-RINGS AND SEALS, DEFLECTOR OPERATING WIRE, DEFLECTOR STAYCOIL, OPERATION CHANNEL, ADJUSTING COLLAR, ANGLE WIRE, BENDING RUBBER, DISTAL CASE/CAP, O-RING(0.5X1.3) IMP-1, RL PULLEY ASSY, UD PULLEY ASSY, O-RING (1.8X19.8). MODEL ED-3490TK, SERIAL NUMBER (B)(4), HAS BEEN ROUTINELY SERVICED AT A

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11355628 ↗
• MalfunctionFeb 19, 2021Loss of or Failure to Bond; Loss of or Failure to Bond

  THE CUSTOMER OWNED DEVICE WAS PREVIOUSLY RETURNED TO PENTAX MEDICAL FROM A CUSTOMER ON 12-JAN-2021 AND INSPECTION OF THE UNIT WAS PERFORMED UNDER SERVICE ORDER 3130940 WHERE THE QUALITY CONTROL INSPECTOR DOCUMENTED THE FOLLOWING CODES ON 13-JAN-2021: DISTAL CAP - FIXED TYPE FAILED EPOXY SEAL INTEGRITY INSPECTION, LIGHT CARRYING BUNDLE BUNDLE HAS LESS THAN 70% TRANSMISSION, DISTAL CAP/ CASE CRACKED, PRIMARY OPERATION CHANNEL RESISTANCE, RIGHT/ LEFT BRAKE KNOB MARKINGS FADED, AIR/ WATER SOCKET CYLINDER O-RING CHIPPED, DISTAL TIP ANNUAL MAINTENANCE, PASSED DRY LEAK TEST, SUCTION TUBE RESISTANCE, SEGMENT STEEL BRAID CUT, PASSED WET LEAK TEST, MIDDLE LCB DISTAL COVER GLASS GLUE IS MISSING, IMAGE DARK, FLUID INVASION NOT OBSERVED IN CONTROL BODY, FLUID INVASION NOT OBSERVED IN PVE CONNECTOR, UMBILICAL CABLE SINGLE BUCKLED UNDER PVE ROOT BRACE, SEGMENT COMPRESSED. THE DUODENOSCOPE'S REPAIRS WILL INCLUDE THE DISTAL CASE/CAP, WHICH WILL BE REPLACED AND/OR RESEALED PURSUANT TO THE FIELD CORRECTION, ALONG WITH THE FOLLOWING PARTS PARTS, AND RETURNED TO THE USER UPON COMPLETION: O-RINGS AND SEALS, AIR/WATER TUBE, DEFLECTOR BODY ATTACHING SCREW, DEFLECTOR OPERATING WIRE, DEFLECTOR STAYCOIL, LCB

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11355498 ↗
• MalfunctionFeb 19, 2021Loss of or Failure to Bond; Loss of or Failure to Bond

  PENTAX OF AMERICA INITIATED FIELD CORRECTION (B)(4) WHICH INCLUDED INSPECTION OF THE SEAL AROUND THE DISTAL BODY AND DISTAL CAP OF THE ED-3490TK DUODENOSCOPE PURSUANT TO PREDEFINED INSPECTION CRITERIA (ET-HF-P-0013 REV. 00). THE OBJECTIVE OF THE INSPECTION WAS TO VERIFY THERE WERE NO DEFECTS/DISCONTINUITIES IN THE SEAL BETWEEN THE DISTAL BODY AND DISTAL CAP. THE INSPECTIONAL CRITERIA WAS DEFINED AS, "ALL SEAL SURFACES OBSERVED SHALL BE CONTINUOUS AND SMOOTH WITH NO OUTWARD SIGNS OF DISCONTINUITY, GAPS OR BUBBLES." A DEVICE WAS CONSIDERED TO FAIL THE INSPECTION IF ANY ELEMENT OF THE CRITERIA WAS NOT MET. THE CUSTOMER OWNED DEVICE WAS PREVIOUSLY RETURNED TO PENTAX MEDICAL FROM A CUSTOMER ON 26-JAN-2021 AND INSPECTION OF THE UNIT WAS PERFORMED UNDER SERVICE ORDER (B)(4) WHERE THE QUALITY CONTROL INSPECTOR DOCUMENTED THE FOLLOWING CODES ON 26-JAN-2021: DISTAL CAP - FIXED TYPE FAILED SEAL INTEGRITY INSPECTION, INSERTION TUBE PERFORATION AT STAGE 1, FAILED DRY LEAK TEST, DISTAL CAP - FIXED TYPE DISTAL TIP UPGRADE, AIR/ WATER SOCKET CYLINDER O-RING CHIPPED, UP/ DOWN BRAKE KNOB/ LEVER MARKINGS FADED, RIGHT/ LEFT BRAKE KNOB MARKINGS FADED, LEAK AT INSERTION TUBE STAGE 1, FAILED WET LEAK TES

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11355476 ↗
• MalfunctionFeb 19, 2021Loss of or Failure to Bond; Loss of or Failure to Bond

  THE CUSTOMER OWNED DEVICE WAS PREVIOUSLY RETURNED TO PENTAX MEDICAL FROM A CUSTOMER ON 25-JAN-2021 AND INSPECTION OF THE UNIT WAS PERFORMED UNDER SERVICE ORDER (B)(4) WHERE THE QUALITY CONTROL INSPECTOR DOCUMENTED THE FOLLOWING CODES ON 26-JAN-2021: DISTAL CAP - FIXED TYPE FAILED EPOXY SEAL INTEGRITY INSPECTION, LEAK AT BIOPSY CHANNEL (LARGE/ PRIMARY) DISTAL SID, DISTAL CAP/ CASE CRACKED, MIDDLE LCB DISTAL COVER GLASS GLUE IS MISSING, FAILED WET LEAK TEST, SUCTION TUBE RESISTANCE, FAILED DRY LEAK TEST, SEGMENT SCREW LOOSE AT INSERTION TUBE, UMBILICAL CABLE,MILD CRUSH. THE DUODENOSCOPE'S REPAIRS WILL INCLUDE THE DISTAL CASE/CAP, WHICH WILL BE REPLACED AND/OR RESEALED PURSUANT TO THE FIELD CORRECTION, ALONG WITH THE FOLLOWING PARTS, AND RETURNED TO THE USER UPON COMPLETION: O-RINGS AND SEALS, AIR/WATER TUBE, DEFLECTOR OPERATING WIRE, DEFLECTOR STAY COIL, OPERATION CHANNEL, BENDING RUBBER, DISTAL CASE/CAP, SUCTION CHANNEL LG, O-RING(0.5X1.3) IMP-1. MODEL ED-3490TK, SERIAL NUMBER (B)(4), HAS BEEN ROUTINELY SERVICED AT A PENTAX FACILITY SINCE THE DEVICE WAS PUT INTO SERVICE ON (B)(6) 2015. THE ENDOSCOPE IS AWAITING REPAIR OR APPROVAL BY FINAL QC AS OF 19-FEB-2021.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11355475 ↗
• MalfunctionFeb 19, 2021Loss of or Failure to Bond; Loss of or Failure to Bond

  THE CUSTOMER OWNED DEVICE WAS PREVIOUSLY RETURNED TO PENTAX MEDICAL FROM A CUSTOMER ON (B)(6) 2021 AND INSPECTION OF THE UNIT WAS PERFORMED UNDER SERVICE ORDER (B)(4) WHERE THE QUALITY CONTROL INSPECTOR DOCUMENTED THE FOLLOWING CODES ON 20-JAN-2021: DISTAL CAP - FIXED TYPE FAILED EPOXY SEAL INTEGRITY INSPECTION, PRIMARY OPERATION CHANNEL RESISTANCE, DISTAL TIP ANNUAL MAINTENANCE, FAILED DRY LEAK TEST, UP/ DOWN CONTROL KNOB/ LEVER MARKINGS FADED, REMOTE CONTROL BUTTON CASE CRACKED UNDER #2 BUTTON, LEAK AT REMOTE CONTROL BUTTON CASE, PASSED WET LEAK TEST, DISTAL CAP/ CASE CRACKED, FLUID INVASION IN CONTROL BODY, MIDDLE LCB DISTAL COVER GLASS GLUE IS MISSING, CONTROL BODY MILD CORROSION INSIDE, FLUID INVASION NOT OBSERVED IN PVE CONNECTOR, UMBILICAL CABLE SINGLE BUCKLED UNDER PVE ROOT BRACE. THE DUODENOSCOPE'S REPAIRS WILL INCLUDE THE DISTAL CASE/CAP, WHICH WILL BE REPLACED AND/OR RESEALED PURSUANT TO THE FIELD CORRECTION, ALONG WITH THE FOLLOWING PARTS, AND RETURNED TO THE USER UPON COMPLETION: O-RINGS AND SEALS, AIR/WATER TUBE, DEFLECTOR OPERATING WIRE, DEFLECTOR STAYCOIL, OPERATION CHANNEL ADJUSTING COLLAR, BENDING RUBBER, DISTAL CASE/CAP, RL PULLEY ASSY, UD PULLEY ASSY, R.C BUTTON

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11355397 ↗
• MalfunctionJan 28, 2021Loss of or Failure to Bond; Loss of or Failure to Bond

  PENTAX OF AMERICA INITIATED FIELD CORRECTION 2017- 001- C WHICH INCLUDED INSPECTION OF THE SEAL AROUND THE DISTAL BODY AND DISTAL CAP OF THE ED-3490TK DUODENOSCOPE PURSUANT TO PREDEFINED INSPECTION CRITERIA (ET-HF-P-0013 REV. 00). THE OBJECTIVE OF THE INSPECTION WAS TO VERIFY THERE WERE NO DEFECTS/DISCONTINUITIES IN THE SEAL BETWEEN THE DISTAL BODY AND DISTAL CAP. THE INSPECTIONAL CRITERIA WAS DEFINED AS, "ALL SEAL SURFACES OBSERVED SHALL BE CONTINUOUS AND SMOOTH WITH NO OUTWARD SIGNS OF DISCONTINUITY, GAPS OR BUBBLES." A DEVICE WAS CONSIDERED TO FAIL THE INSPECTION IF ANY ELEMENT OF THE CRITERIA WAS NOT MET. THE CUSTOMER OWNED DEVICE WAS PREVIOUSLY RETURNED TO PENTAX MEDICAL FROM A CUSTOMER ON 07-JUN-2018 AND INSPECTION OF THE UNIT WAS PERFORMED UNDER SERVICE ORDER (B)(4) WHERE THE QUALITY CONTROL INSPECTOR DOCUMENTED THE FOLLOWING CODES ON 12-JUN-2018: DISTAL CAP - FIXED TYPE FAILED SEAL INTEGRITY INSPECTION, PASSED DRY LEAK TEST, PRIMARY OPERATION CHANNEL EXCESS GLUE AT DISTAL END, PASSED WET LEAK TEST, PRISM LENS CHIPPED, IMAGE MILD SPOT. INSPECTION OF THE SEAL BETWEEN THE DISTAL BODY AND DISTAL CAP WAS PERFORMED AND THE DEVICE FAILED THE INSPECTION CRITERIA. THE ENDOSCOP'S REP

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11244687 ↗
• MalfunctionJan 28, 2021Loss of or Failure to Bond; Loss of or Failure to Bond

  THE CUSTOMER OWNED DEVICE WAS PREVIOUSLY RETURNED TO PENTAX MEDICAL FROM A CUSTOMER ON 15-OCT-2018 AND INSPECTION OF THE UNIT WAS PERFORMED UNDER SERVICE ORDER (B)(4) WHERE THE QUALITY CONTROL INSPECTOR DOCUMENTED THE FOLLOWING CODES ON 17-OCT-2018: DISTAL CAP - FIXED TYPE FAILED EPOXY SEAL INTEGRITY INSPECTION, , ELEVATOR BODY STICKING, AIR/ WATER SOCKET CYLINDER O-RING CHIPPED, DISTAL CAP/ CASE CRACKED, MIDDLE LIGHT CARRYING BUNDLE DISTAL COVER GLASS CRACKED, PASSED WET LEAK TEST, PASSED DRY LEAK TEST, OPERATION CHANNEL- PRIMARY MILD RESISTANCE, FLUID INVASION NOT OBSERVED IN CONTROL BODY, FLUID INVASION NOT OBSERVED IN PVE CONNECTOR, UMBILICAL CABLE SINGLE BUCKLED UNDER PVE ROOT BRACE. THE DUODENOSCOPE'S REPAIRS WILL INCLUDE THE DISTAL CASE/CAP, WHICH WILL BE REPLACED AND/OR RESEALED PURSUANT TO THE FIELD CORRECTION, ALONG WITH THE FOLLOWING PARTS , AND RETURNED TO THE USER UPON COMPLETION: O-RINGS AND SEALS, DEFLECTOR OPERATING WIRE, LCB DISTAL COVER, DISTAL CASE/CAP, DISTAL CASE/CAP, BENDING RUBBER, OPERATION CHANNEL, BENDING RUBBER, AIR/WATER TUBE. MODEL ED-3490TK, SERIAL NUMBER (B)(4), HAS BEEN ROUTINELY SERVICED AT A PENTAX FACILITY SINCE THE DEVICE WAS PUT INTO SERVICE ON

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11244497 ↗
• MalfunctionJan 20, 2021Device Damaged by Another Device; Device Damaged by Another Device

  PENTAX MEDICAL WAS MADE AWARE OF A COMPLAINT ON 01-DEC-2020 OF "RESISTANCE PRIMARY BIOPSY CHANNEL" WITH THE REPORTER STATING "SOMETHING STUCK INSIDE" FOUND DURING REPROCESSING AFTER THE CURRENT PROCEDURE, INVOLVING THE PENTAX MEDICAL VIDEO DUODENOSCOPE, MODEL ED-3490TK, SERIAL NUMBER (B)(4). NO SERIOUS INJURY OR DEATH OF A PATIENT OR USER WAS REPORTED. THREE GOOD FAITH EFFORT(GFE) EMAIL REQUESTS WERE SENT TO THE USER FACILITY, 28-OCT-2020, 02-NOV-2020 AND AGAIN ON 05-NOV-2020, WITH NO ADDITIONAL INFORMATION BEING PROVIDED. THE CUSTOMER OWNED ENDOSCOPE WAS RECEIVED BY PENTAX MEDICAL FOR EVALUATION ON 15-OCT-2020. DURING EVALUATION OF THE ENDOSCOPE UNDER SERVICE ORDER (B)(4), THE PENTAX MEDICAL SERVICE REPAIR TECHNICIAN FOUND AN "ACCESSORY STUCK IN PRIMARY OPERATION CHANNEL" CONFIRMING THE CUSTOMER'S COMPLAINT AND DOCUMENTING THE FOLLOWING ADDITIONAL FINDINGS ON 27-OCT-2020: BIOPSY INLET T-PIECE STUCK ACCESSORY AT AFT TUBE, PASSED DRY LEAK TEST, PRISM SCRATCHED, PASSED WET LEAK TEST, DISTAL CAP/ CASE CRACKED, IMAGE MILD SPOT, FLUID INVASION NOT OBSERVED IN CONTROL BODY, FLUID INVASION NOT OBSERVED IN PVE CONNECTOR, PRISM GLASS GLUE MISSING. THE DEVICE UNDERWENT REPAIRS INCLUDING THE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11205364 ↗
• MalfunctionJan 14, 2021Loss of or Failure to Bond; Loss of or Failure to Bond

  THE CUSTOMER OWNED DEVICE WAS PREVIOUSLY RETURNED TO PENTAX MEDICAL FROM A CUSTOMER ON 14-DEC-2020 AND INSPECTION OF THE UNIT WAS PERFORMED UNDER SERVICE ORDER (B)(4) WHERE THE QUALITY CONTROL INSPECTOR DOCUMENTED THE FOLLOWING CODES ON 16-DEC-2020: DISTAL CAP - FIXED TYPE FAILED EPOXY SEAL INTEGRITY INSPECTION, OPERATION CHANNEL TWISTED IN BENDING SECTION, DISTAL TIP ANNUAL MAINTENANCE, DISTAL CAP/ CASE CRACKED, PASSED WET LEAK TEST, RESIDUE ON AIR/WATER SOCKET, PASSED DRY LEAK TEST, UMBILICAL CABLE BUMP UNDER PVE ROOT BRACE, INSERTION TUBE MILD CRUSH AT STAGE 1. THE DUODENOSCOPE'S REPAIRS WILL INCLUDE THE DISTAL CASE/CAP, WHICH WILL BE REPLACED AND/OR RESEALED PURSUANT TO THE FIELD CORRECTION, ALONG WITH THE FOLLOWING PARTS, AND RETURNED TO THE USER UPON COMPLETION: O-RINGS AND SEALS, AIR/WATER TUBE, DEFLECTOR OPERATING WIRE, DEFLECTOR STAYCOIL, OPERATION CHANNEL, ADJUSTING COLLAR, ANGLE WIRE, BENDING RUBBER, DISTAL CASE/CAP, DISTAL CASE ATTACHING SCREW, RL PULLEY ASSY, UD PULLEY ASSY, O-RING(0.5X1.3) IMP-1, O-RING (1.8X19.8), DEFLECTOR LEVER. MODEL ED-3490TK, SERIAL NUMBER (B)(4), HAS BEEN ROUTINELY SERVICED AT A PENTAX FACILITY SINCE THE DEVICE WAS PUT INTO SERVICE ON (B)(6) 20

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11173988 ↗
• MalfunctionDec 21, 2020Device Damaged by Another Device; Device Damaged by Another Device

  PENTAX MEDICAL WAS MADE AWARE OF A COMPLAINT ON 23-NOV-2020 UNDER RMA NOTIFICATION (B)(4) FOR A "BRUSH STUCK/BROKEN IN CHANNEL - SOMETHING STUCK IN SCOPE" FOUND DURING REPROCESSING, INVOLVING PENTAX MEDICAL VIDEO DUODENOSCOPE MODEL ED-3490TK, SERIAL NUMBER (B)(4) AT (B)(6). THE USER FACILITY REPLIED VIA EMAIL TO A GOOD FAITH EFFORT EMAIL ON 08-DEC-2020 STATING AN UNKNOWN PLASTIC STENT BECAME STUCK IN THE ENDOSCOPE AND WAS UNABLE TO BE REMOVED EVEN THOUGH THE ENDOSCOPE WAS THE APPROPRIATE SIZE TO ALLOW THE STENT TO PASS. THE ENDOSCOPE WAS REMOVED FROM SERVICE AFTER THE INCIDENT AND RETURNED TO PENTAX MEDICAL FOR EVALUATION. THE STENT MODEL AND SERIAL WERE NOT PROVIDED. NO ADDITIONAL INFORMATION WAS PROVIDED. THE CUSTOMER OWNED ENDOSCOPE WAS RECEIVED BY PENTAX MEDICAL FOR EVALUATION ON 11-DEC-2020. DURING EVALUATION OF THE ENDOSCOPE UNDER SERVICE ORDER (B)(4) , THE PENTAX MEDICAL SERVICE REPAIR TECHNICIAN FOUND AN "ACCESSORY STUCK IN PRIMARY OPERATION CHANNEL" CONFIRMING THE CUSTOMER'S COMPLAINT AND DOCUMENTING THE FOLLOWING ADDITIONAL FINDINGS ON 14-DEC-2020: A 62 INSERTION TUBE POLYURETHANE DAMAGED AT SEGMENT SIDE UNDER THE ROOT BRACE, UP/ DOWN CONTROL KNOB/ LEVER MARKINGS FADED, R

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11051666 ↗
• MalfunctionDec 15, 2020Loss of or Failure to Bond; Loss of or Failure to Bond

  THE CUSTOMER OWNED DEVICE WAS PREVIOUSLY RETURNED TO PENTAX MEDICAL FROM A CUSTOMER ON 20-NOV-2020 AND INSPECTION OF THE UNIT WAS PERFORMED UNDER SERVICE ORDER (B)(4) WHERE THE QUALITY CONTROL INSPECTOR DOCUMENTED THE FOLLOWING CODES ON 30-NOV-2020: DISTAL CAP - FIXED TYPE FAILED EPOXY SEAL INTEGRITY INSPECTION, PRIMARY OPERATION CHANNEL RESISTANCE, PRISM SCRATCHED, BENDING RUBBERSEVERE DISCOLORATION, DISTAL CAP/ CASE CRACKED, BIOPSY INSULATION RING DEFORMED, IMAGE BLACKOUT, MIDDLE LCB DISTAL COVER GLASS GLUE IS MISSING, PASSED WET LEAK TEST, PASSED DRY LEAK TEST. THE DUODENOSCOPE'S REPAIRS WILL INCLUDE THE DISTAL CASE/CAP, WHICH WILL BE REPLACED AND/OR RESEALED PURSUANT TO THE FIELD CORRECTION, ALONG WITH THE FOLLOWING PARTS, AND RETURNED TO THE USER UPON COMPLETION: O-RINGS AND SEALS, DISTAL END W/CCD-M IMP-T PB-FREE/NT, ADJUSTING COLLAR, ANGLE WIRE, BENDING RUBBER, DISTAL CASE/CAP, DISTAL CASE ATTACHING SCREW, RL PULLEY ASSY, UD PULLEY ASSY, ELECTRICAL CONNECTOR ASSY, O-RING(0.5X1.3) IMP-1, DEFLECTOR OPERATING WIRE, DEFLECTOR STAYCOIL. THE ENDOSCOPE IS AWAITING REPAIR OR APPROVAL BY FINAL QC AS OF 14-DEC-2020.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11008845 ↗