VIDEO DUODENOSCOPE ED34-I10T-US (UDI 04961333232956)Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 04961333232956), received between Nov 20, 2020 and Apr 5, 2022 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Break” (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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 5, 2022Break; Break

  THE TIME OF EVENT IS UNKNOWN. THERE WAS NO REPORT OF PATIENT HARM. VIDEO IMAGE FAILURE(OBJECTIVE LENS BROKEN).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14008476 ↗
• MalfunctionMar 15, 2022Break; Break

  THE TIME OF EVENT IS UNKNOWN. THERE WAS NO REPORT OF PATIENT HARM. VIDEO IMAGE FAILURE(OBJECTIVE LENS BROKEN).

  MAUDE report 13767997 ↗
• MalfunctionJul 30, 2021Break; Degraded; Break; Degraded

  DATE OF EVENT NOT KNOWN FOR THE EXACT DATE, WE JUST KNOW THE YEAR THE COMPLAINT WAS SENT IN TO MANUFACTURER. THIS EVENT OCCURRED AT THE TIME OF REPROCESSING. THERE WAS NO REPORT OF PATIENT HARM. ACCESSORY STUCK IN SCOPE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12250883 ↗
• MalfunctionJul 24, 2021Fracture; Loose or Intermittent Connection; Material Split, Cut or Torn; Fracture; Loose or Intermittent Connection; Material Split, Cut or Torn

  THE TIME OF EVENT IS UNKNOWN. THERE WAS NO REPORT OF PATIENT HARM. VIDEO IMAGE IS DARK - FIBERS BROCKEN. LCB BROKEN, REDUCED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12222428 ↗
• MalfunctionNov 20, 2020Microbial Contamination of Device; Microbial Contamination of Device

  PENTAX MEDICAL WAS MADE AWARE OF AN EVENT ON (B)(6) 2020 THAT OCCURRED AFTER REPROCESSING IN THE UNITED STATES. THE REPORTED COMPLAINT THAT THERE IS POTENTIAL ENDOSCOPE CONTAMINATION AS THE ENDOSCOPE FAILED CHANNEL CHECK TESTING 3 TIMES AFTER REPROCESSING, INVOLVING THE PENTAX MEDICAL VIDEO DUODENOSCOPE, MODEL ED34-I10T-US, SERIAL NUMBER: (B)(4). NO PATIENT INVOLVEMENT WAS REPORTED. THE CUSTOMER OWNED DUODENOSCOPE WAS RECEIVED BY PENTAX MEDICAL FOR EVALUATION ON 23-OCT-2020. THE DUODENOSCOPE WAS INSPECTED BY PENTAX MEDICAL A SERVICE REPAIR TECHNICIAN UNDER SERVICE ORDER#: (B)(4), AND DOCUMENTED THE FOLLOWING INSPECTION FINDINGS ON 26-OCT-2020: PRIMARY OPERATION CHANNEL RESISTANCE, LEAK AT # 1 REMOTE CONTROL BUTTON COVER, LCB DISTAL COVER GLASS MODIFIED COVER GLASS CHIPPED/CRACKED, AIR/ WATER SOCKET CYLINDER O-RING CHIPPED, RIGHT/ LEFT BRAKE KNOB MARKINGS FADED, FAILED WET LEAK TEST, FAILED DRY LEAK TEST, HOLE IN # 1 REMOTE CONTROL BUTTON COVER, SLUGGISH WATER DELIVERY FUNCTION, SLUGGISH AIR DELIVERY FUNCTION, INSERTION TUBE MILD DISCOLORATION AT STAGE 1, INSERTION TUBE MILD DISCOLORATION AT STAGE 2, FLUID INVASION NOT OBSERVED IN PVE CONNECTOR, FLUID INVASION NOT OBSERVED IN CONTRO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10874985 ↗