VIDEO DUODENOSCOPE ED34-I10T2Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 04961333240135), received between Oct 8, 2020 and Aug 17, 2021 — classified as 4 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (2 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 17, 2021Mechanical Problem; Mechanical Problem

  PENTAX MEDICAL WAS MADE AWARE OF A COMPLAINT THAT OCCURRED IN THE UNITED STATES. IT WAS REPORTED TO PENTAX MEDICAL FROM THE FACILITY THAT THERE WAS DECREASED ELEVATOR ANGULATION WITH PENTAX MEDICAL VIDEO DUODENOSCOPE MODEL ED34-I10T2-US, SERIAL NUMBER (B)(4). A NARRATED VIDEO OF THE ISSUE WAS PROVIDED BY THE CUSTOMER AND INDICATED THAT THE ELEVATOR WAS SLOW TO RETRACT AT ALL WHEN THE ENDOSCOPE WAS AT A 90 DEGREE ANGLE. DISTAL END CAP 0011120 WAS BEING USED WITH THE DUODENOSCOPE. THE CUSTOMER OWNED ENDOSCOPE WAS RECEIVED BY PENTAX MEDICAL FOR EVALUATION ON 29-JUL-2021. THE ENDOSCOPE WAS INSPECTED BY PENTAX MEDICAL SERVICE UNDER SERVICE ORDER (B)(4) AND THE TECHNICIAN CONFIRMED THE CUSTOMER COMPLAINT AS "ELEVATOR DEFLECTION MOVEMENT IS SLUGGISH" AND DOCUMENTED THE FOLLOWING INSPECTION FINDINGS: LCB DISTAL COVER GLASS MODIFIED COVER GLASS CHIPPED/CRACKED, PASSED WET LEAK TEST, PASSED DRY LEAK TEST. THE DEVICE UNDERWENT REPAIRS INCLUDING THE FOLLOWING COMPONENTS: O-RINGS AND SEALS, O-RING(0.5X1.3) IMP-1, DEFLECTOR OPERATING WIRE, LCB DISTAL COVER GLASS. THE ENDOSCOPE IS AWAITING REPAIR AND APPROVED BY FINAL QC AS 16-AUG-2021. THIS IS THE FIRST TIME PENTAX MODEL ED34-I10T2-US, SERIAL NU

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12331957 ↗
• MalfunctionJul 27, 2021No Display/Image; Display or Visual Feedback Problem; No Display/Image; Display or Visual Feedback Problem

  PENTAX MEDICAL WAS MADE AWARE OF A COMPLAINT ON 29-JUN-2021 THAT OCCURRED (B)(6) IN THE PAI REGION. THE ENDOSCOPE FAILED TO PROVIDE AN IMAGE WHEN CONNECTED TO THE VIDEO PROCESSOR. POSSIBLE OUT OF BOX FAILURE INVOLVING PENTAX MEDICAL VIDEO DUODENOSCOPE MODEL ED34-I10T2, SERIAL NUMBER (B)(4). PENTAX MEDICAL CUSTOMER SERVICE ADDED THE TEXT "FAILED CONNECTION TO PROCESSOR" TO THE RMA NOTIFICATION. THE DEVICE WAS SENT TO A LOCAL DISTRIBUTOR FOR ANALYSIS AND IS NOW PENDING RETURN TO PENTAX MEDICAL FOR EVALUATION. THE LOANER ENDOSCOPE IS PART OF A 522 STUDY AND HAS NOT BEEN RECEIVED BY PENTAX MEDICAL FOR EVALUATION AS OF 27-JUL-2021. THE INVESTIGATION IS IN-PROCESS.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 12235246 ↗
• MalfunctionJul 27, 2021No Display/Image; Display or Visual Feedback Problem; No Display/Image; Display or Visual Feedback Problem

  PENTAX MEDICAL WAS MADE AWARE OF A COMPLAINT ON 29-JUN-2021 THAT OCCURRED (B)(6) IN THE PAI REGION. THE ENDOSCOPE FAILED TO PROVIDE AN IMAGE WHEN CONNECTED TO THE VIDEO PROCESSOR. POSSIBLE OUT OF BOX FAILURE INVOLVING PENTAX MEDICAL VIDEO DUODENOSCOPE MODEL ED34-I10T2, SERIAL NUMBER (B)(4). PENTAX MEDICAL CUSTOMER SERVICE ADDED THE TEXT "FAILED CONNECTION TO PROCESSOR" TO THE RMA NOTIFICATION. THE DEVICE WAS SENT TO A LOCAL DISTRIBUTOR FOR ANALYSIS AND IS NOW PENDING RETURN TO PENTAX MEDICAL FOR EVALUATION. THE LOANER ENDOSCOPE IS PART OF A 522 STUDY AND HAS NOT BEEN RECEIVED BY PENTAX MEDICAL FOR EVALUATION AS OF 27-JUL-2021. THE INVESTIGATION IS IN-PROCESS.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 12234761 ↗
• InjuryFeb 12, 2021Sharp Edges; Sharp Edges

  PENTAX MEDICAL WAS MADE AWARE OF A COMPLAINT THAT OCCURRED IN THE OPERATING ROOM AFTER THE COMPLETION OF A PROCEDURE IN THE UNITED STATES. THE REPORTED COMPLAINT WAS THAT AFTER THE SUCCESSFUL COMPLETION OF AN ERCP(ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY) PROCEDURE PERFORMED ON (B)(6) 2021, A NURSE PRICKED HER FINGER ON A SHARP OBJECT STICKING OUT OF THE PENTAX MEDICAL VIDEO DUODENOSCOPE, MODEL ED34-I10T2, SERIAL NUMBER (B)(4). BASED ON ADDITIONAL DETAILS PROVIDED BY THE PENTAX SALES REP VIA PHONE ON (B)(6) 2021, ALTHOUGH NO BLOOD WAS NOTED, THE NURSE DID GO TO THE EMERGENCY ROOM FOR EVALUATION AFTER BEING PRICKED BY THE SHARP OBJECT. DURING THE ERCP PROCEDURE A DILATION BALLOON CATHETER AND SPHINCTEROTOME WERE USED FOR A SPHINCTEROTOMY, BOTH UNKNOWN MAKE, MODEL, AND LOT NUMBERS. THE HOSPITAL INITIALLY BELIEVED THAT THE SHARP OBJECT STICKING OUT OF THE PENTAX MEDICAL VIDEO DUODENOSCOPE BIOPSY PORT ORIGINATED FROM THE SPHINCTEROTOME, AND AFTER FURTHER REVIEW, THEY FEEL STRONGER THAT THE SHARP OBJECT IS IN FACT FROM THE SPHINCTEROTOME AS COMMUNICATED TO OUR PENTAX MEDICAL REGIONAL SALES REPRESENTATIVE. THIS SHARP PORTION OF THE SPHINCTEROTOME IS WHAT THE USER PRICKED HER FINGER

  Patient problems: Insufficient Information; Needle Stick/Puncture

  MAUDE report 11325547 ↗
• InjuryFeb 12, 2021Sharp Edges; Sharp Edges

  PENTAX MEDICAL WAS MADE AWARE OF A COMPLAINT THAT OCCURRED IN THE OPERATING ROOM AFTER THE COMPLETION OF A PROCEDURE IN THE UNITED STATES. THE REPORTED COMPLAINT WAS THAT AFTER THE SUCCESSFUL COMPLETION OF AN ERCP(ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY) PROCEDURE PERFORMED ON (B)(6) 2021, A NURSE PRICKED HER FINGER ON A SHARP OBJECT STICKING OUT OF THE PENTAX MEDICAL VIDEO DUODENOSCOPE, MODEL ED34-I10T2, SERIAL NUMBER (B)(4). BASED ON ADDITIONAL DETAILS PROVIDED BY THE PENTAX SALES REP VIA PHONE ON 26-JAN-2021, ALTHOUGH NO BLOOD WAS NOTED, THE NURSE DID GO TO THE EMERGENCY ROOM FOR EVALUATION AFTER BEING PRICKED BY THE SHARP OBJECT. DURING THE ERCP PROCEDURE A DILATION BALLOON CATHETER AND SPHINCTEROTOME WERE USED FOR A SPHINCTEROTOMY, BOTH UNKNOWN MAKE, MODEL, AND LOT NUMBERS. THE HOSPITAL INITIALLY BELIEVED THAT THE SHARP OBJECT STICKING OUT OF THE PENTAX MEDICAL VIDEO DUODENOSCOPE BIOPSY PORT ORIGINATED FROM THE SPHINCTEROTOME, AND AFTER FURTHER REVIEW, THEY FEEL STRONGER THAT THE SHARP OBJECT IS IN FACT FROM THE SPHINCTEROTOME AS COMMUNICATED TO OUR PENTAX MEDICAL REGIONAL SALES REPRESENTATIVE. THIS SHARP PORTION OF THE SPHINCTEROTOME IS WHAT THE USER PRICKED HER FINGER

  Patient problems: Insufficient Information; Needle Stick/Puncture

  MAUDE report 11325545 ↗
• InjuryOct 8, 2020Detachment of Device or Device Component; Misassembly by Users; Detachment of Device or Device Component; Misassembly by Users

  PENTAX MEDICAL WAS MADE AWARE OF AN EVENT THAT OCCURRED IN THE OPERATING ROOM DURING USE IN (B)(6). THE REPORTED COMPLAINT RECEIVED ON (B)(6) 2020 STATED THAT THE USER FACILITY USED A PENTAX MEDICAL DEMO VIDEO DUODENOSCOPE, MODEL ED34-I10T2 - SERIAL NUMBER (B)(4), AT THE USER FACILITY FOR AN EMERGENCY ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY(ERCP) WITHOUT A PENTAX MEDICAL REPRESENTATIVE ON SITE. DURING THE ERCP, THE FACILITY MISTAKENLY USED A CAP INTENDED FOR USE WITH THE FACILITIES MODEL ED34-I10T ENDOSCOPE ON THE PENTAX MEDICAL VIDEO DUODENOSCOPE MODEL ED34-I10T2 ENDOSCOPE. THE FACILITY USED A T SCOPE CAP, MODEL OE-A55, INSTEAD OF THE DISPOSABLE STERILE DISTAL END CAP, MODEL OE-A63. AS A RESULT, THE OE-A55 WITH AN UNKNOWN LOT NUMBER, FELL OFF WITHIN THE PATIENT. NO RETRIEVAL WAS PERFORMED DURING THE PROCEDURE. THE PHYSICIAN MADE THE DECISION TO LET THE CAP PASS NATURALLY. ONCE THE CAP PASSES, IT WILL BE DISCARDED BY THE PATIENT, SO WILL BE UNAVAILABLE FOR EVALUATION. THE FACILITY IS REMOVING THE ED34-I10T2 SCOPE FROM THE FLEET TO ENSURE THAT THIS DOES NOT HAPPEN AGAIN. NO ADDITIONAL INFORMATION WAS PROVIDED AT THE TIME OF REPORTING. PENTAX (B)(4) PROVIDED AN UPDATE ON 23-SE

  Patient problems: Foreign Body In Patient

  MAUDE report 10652906 ↗
• InjuryOct 8, 2020Detachment of Device or Device Component; Misassembly by Users; Detachment of Device or Device Component; Misassembly by Users

  PENTAX MEDICAL WAS MADE AWARE OF AN EVENT THAT OCCURRED IN THE OPERATING ROOM DURING USE IN (B)(6). THE REPORTED COMPLAINT RECEIVED ON 08-SEP-2020 STATED THAT THE USER FACILITY USED A PENTAX MEDICAL DEMO VIDEO DUODENOSCOPE, MODEL ED34-I10T2 - SERIAL NUMBER (B)(4), AT THE USER FACILITY FOR AN EMERGENCY ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY(ERCP) WITHOUT A PENTAX MEDICAL REPRESENTATIVE ON SITE. DURING THE ERCP, THE FACILITY MISTAKENLY USED A CAP INTENDED FOR USE WITH THE FACILITIES MODEL ED34-I10T ENDOSCOPE ON THE PENTAX MEDICAL VIDEO DUODENOSCOPE MODEL ED34-I10T2 ENDOSCOPE. THE FACILITY USED A T SCOPE CAP, MODEL OE-A55, INSTEAD OF THE DISPOSABLE STERILE DISTAL END CAP, MODEL OE-A63. AS A RESULT, THE OE-A55 WITH AN UNKNOWN LOT NUMBER, FELL OFF WITHIN THE PATIENT. NO RETRIEVAL WAS PERFORMED DURING THE PROCEDURE. THE PHYSICIAN MADE THE DECISION TO LET THE CAP PASS NATURALLY. ONCE THE CAP PASSES, IT WILL BE DISCARDED BY THE PATIENT, SO WILL BE UNAVAILABLE FOR EVALUATION. THE FACILITY IS REMOVING THE ED34-I10T2 SCOPE FROM THE FLEET TO ENSURE THAT THIS DOES NOT HAPPEN AGAIN. NO ADDITIONAL INFORMATION WAS PROVIDED AT THE TIME OF REPORTING. PENTAX (B)(4) INC.(PCI) PROVIDED AN UPDAT

  Patient problems: Foreign Body In Patient

  MAUDE report 10652905 ↗