VIDEO DUODENOSCOPE ED34-I10T-US (UDI 04961333240142)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 04961333240142), received between Nov 13, 2020 and Feb 4, 2021 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Failure to Disconnect” (3 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 18, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 4, 2021Failure to Disconnect; Failure to Disconnect

  WE RECEIVED A NOTIFICATION ON 28-DEC-2020 REGARDING A FAILED WET LEAK TEST INVOLVING PENTAX MEDICAL VIDEO DUODENOSCOPE, MODEL ED34-I10T-US, SERIAL NUMBER (B)(4) AT (B)(6). GOOD FAITH EFFORTS PHONE CALLS WERE PLACED ON 01-FEB-2021 AND 04-FEB-2021, AS WELL AS AN EMAIL ON 04-FEB-2021 TO GATHER ADDITIONAL EVENT DETAILS AND TO IDENTIFY THE MANUFACTURER, MODEL AND LOT NUMBER OF THE BROKEN ACCESSORY. NO OTHER INFORMATION HAS BEEN PROVIDED AS OF 04-FEB-2021. THE CUSTOMER OWNED ENDOSCOPE WAS RETURNED FOR EVALUATION ON 04-JAN-2021. DURING EVALUATION OF THE ENDOSCOPE UNDER SERVICE ORDER (B)(4) AND THE TECHNICIAN DOCUMENTED AN ACCESSORY STUCK IN PRIMARY OPERATION CHANNEL AS WELL AS THE FOLLOWING INSPECTION FINDINGS ON 05-JAN-2021: IMAGE SHADOWS, FAILED WET LEAK TEST, SUCTION TUBE RESISTANCE, FAILED DRY LEAK TEST, BENDING RUBBER PINHOLE, UMBILICAL CABLE BUMP UNDER PVE ROOT BRACE, LIGHT CARRYING BUNDLE DISTAL COVER GLASS SINGLE CHIPPED, PRISM SCRATCHED. THE DEVICE UNDERWENT REPAIRS INCLUDING THE FOLLOWING COMPONENTS: O-RINGS AND SEALS, BENDING RUBBER, OPERATION CHANNEL, OBJECTIVE PRISM ASSY, LCB DISTAL COVER GLASS, ANGLE WIRE, SUCTION CHANNEL LG, O-RING (0.5X1.3) IMP-1, O-RING (1.8X19.8), 2-4 RE

  Patient problems: Insufficient Information

  MAUDE report 11283283 ↗
• MalfunctionNov 13, 2020Failure to Disconnect; Failure to Disconnect

  PENTAX MEDICAL WAS MADE AWARE OF A COMPLAINT ON 31-OCT-2019 STATING "OPERATION CHANNEL BLOCKED" INVOLVING THE PENTAX MEDICAL VIDEO DUODENOSCOPE MODEL ED34-I10T-US, SERIAL NUMBER (B)(4). THE USER ALSO REPORTED "STENT STUCK IN OP CHANNEL - DEMO - DURING THE PROCEDURE". PENTAX MEDICAL HAS MADE THREE GOOD FAITH EFFORT(GFE) ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION; HOWEVER, NO ADDITION INFORMATION HAS BEEN PROVIDED. NO SERIOUS INJURY OR DEATH OF A PATIENT OR USER, OR DELAY IN THE PROCEDURE WHICH WOULD REQUIRE MEDICAL INTERVENTION WAS REPORTED. THE LOANER DUODENOSCOPE WAS RETURNED FOR EVALUATION ON 07-NOV-2019. DURING EVALUATION OF THE ENDOSCOPE UNDER SERVICE ORDER (B)(4), THE PENTAX MEDICAL SERVICE REPAIR TECHNICIAN FOUND AN "ACCESSORY STUCK IN PRIMARY OPERATIONAL CHANNEL" CONFIRMING THE CUSTOMER'S COMPLAINT AND DOCUMENTING THE FOLLOWING ADDITIONAL FINDINGS ON 19-NOV-2019: PASSED DRY LEAK TEST, BENDING RUBBER GLUE PINHOLE, PASSED WET LEAK TEST, MIDDLE LIGHT CARRYING BUNDLE DISTAL COVER GLASS CRACKED. THE DEVICE UNDERWENT REPAIRS INCLUDING THE FOLLOWING COMPONENTS: DEFLECTOR OPERATING WIRE, DEFLECTOR STAYCOIL, BENDING RUBBER, AIR/WATER TUBE, LCB DISTAL COVER, DEFLECTOR LEVER, OBJECTIVE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10840131 ↗
• MalfunctionNov 13, 2020Failure to Disconnect; Failure to Disconnect

  PENTAX MEDICAL WAS MADE AWARE OF A COMPLAINT ON 12-DEC-2019 STATING, "RESISTANCE PRIMARY BIOPSY CHANNEL," INVOLVING THE PENTAX MEDICAL C.A.P. HD DUODENOSCOPE (U.S.), MODEL ED34-I10T-US, SERIAL NUMBER (B)(4). THE END USER ALSO STATED A 107 BOSTON SCIENTIFIC PLASTIC STENT BECAME STUCK IN THE CHANNEL DURING THE PROCEDURE. NO ADVERSE EVENTS OR DELAY IN THE PROCEDURE, WHICH WOULD REQUIRE MEDICAL INTERVENTION OCCURRED. THE LOANER DUODENOSCOPE WAS RETURNED FOR EVALUATION ON 16-DEC-2019. DURING EVALUATION OF THE ENDOSCOPE UNDER SERVICE ORDER (B)(4), THE PENTAX MEDICAL SERVICE REPAIR TECHNICIAN FOUND AN "ACCESSORY STUCK IN BIOPSY INLET PIECE" CONFIRMING THE CUSTOMER'S COMPLAINT AND DOCUMENTING THE FOLLOWING ADDITIONAL FINDINGS ON 18-DEC-2019: PASSED WET LEAK TEST, PASSED DRY LEAK TEST. THE DEVICE UNDERWENT REPAIRS INCLUDING THE FOLLOWING COMPONENTS: O-RINGS AND SEALS, BENDING RUBBER, AIR/WATER TUBE, OPERATION CHANNEL. ON 09-NOV-2020, A DEVICE HISTORY RECORD(DHR) REVIEW FOR MODEL ED34-I10T-US, SERIAL NUMBER (B)(4) WAS PERFORMED UNDER IVAI-20-110022, THE DHR REVIEW CONFIRMED THE ENDOSCOPE WAS MANUFACTURED ON 09-JUL-2019 UNDER NORMAL CONDITIONS, PASSED ALL REQUIRED INSPECTIONS, AND WAS RELEASE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10840051 ↗