BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PENTAX

    MDR report key: 11421699 · Received March 5, 2021

    Report

    Report Number
    9610877-2021-00002
    Event Type
    Injury
    Date Received
    March 5, 2021
    Date of Event
    July 28, 2020
    Report Date
    July 29, 2020
    Manufacturer
    HOYA CORPORATION PENTAX TOKYO OFFICE
    Product Code
    FDT
    PMA / PMN Number
    K192245
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INTERNATIONAL MEDICAL DEVICE REGULATORS FORUM (IMDRF) ADVERSE EVENT REPORTING. (B)(4). TYPE OF INVESTIGATION: 10 TESTING OF ACTUAL/SUSPECTED DEVICE. INVESTIGATION FINDINGS: 102 INCOMPATIBLE COMPONENT/ACCESSORY. INVESTIGATION CONCLUSIONS: 61 UNINTENDED USE ERROR CAUSED OR CONTRIBUTED TO EVENT.

    Description of Event or Problem · 1

    PENTAX MEDICAL WAS MADE AWARE OF AN EVENT ON 29-JUL-2020 THAT OCCURRED IN THE OPERATING ROOM DURING USE IN THE EMEA REGION. THE USER REPORTED THAT THERE WAS AN "IMPOSSIBILITY TO PASS APC[ARGON PLASMA COAGULATION] PROBES AND CLIPS DUE TO A FAULTY ELEVATOR NOT RETURNING TO A NEUTRAL POSITION", INVOLVING PENTAX MEDICAL ACCESSORY STERILE DISTAL END CAP MODEL OE-A63, LOT NUMBER 0011040, USED WITH PENTAX MEDICAL VIDEO DUODENOSCOPE, MODEL ED34-I10T2, SERIAL NUMBER (B)(4). THERE WAS REPORTED INSTRUMENT DAMAGE AS WELL AS ACTIVE HEMORRHAGE WITHOUT TREATMENT POSSIBILITY. PENTAX EMEA DOCUMENTED THAT THE CUSTOMER USED AN ARGON PLASMA COAGULATION SYSTEM (APC) WITH FIAPC PROBES FROM ERBE AND ACROSS CURRENT ED34-I10T2 IFU [INSTRUCTIONS FOR USE] THE APC SYSTEM IS NOT CLAIMED COMPATIBLE BY PENTAX. THE FIAPC PROBES IFU, ON PAGE 36, AN ENDOSCOPE HAS TO BE SELECTED IN REGARDS WITH THIS OPERATING CHANNEL DIAMETER AND IT IS REPRESENTED A STANDARD ENDOSCOPE (GASTROSCOPE OR COLONOSCOPE), NOT A DUODENOSCOPE. ON 02-DEC-2020, A DEVICE HISTORY RECORD(DHR) REVIEW FOR PENTAX MEDICAL ACCESSORY MODEL OE-A63, LOT #0011040 WAS PERFORMED UNDER (B)(4), THE DHR REVIEW CONFIRMED THE ENDOSCOPE WAS MANUFACTURED ON 15-APR-2020 UNDER NORMAL CONDITIONS, PASSED ALL REQUIRED INSPECTIONS, AND WAS RELEASED ACCORDINGLY. ALSO, THERE WERE NO REWORKS OR CONCESSIONS AND THE DATES OF APPROVAL FOR SHIPMENT AND ACTUAL DATE SHIPPED WERE CONFIRMED FOR 24-APR-2020. EVALUATION OF THE RETURNED PENTAX MEDICAL ACCESSORY STERILE DISTAL END CAP MODEL OE-A63, LOT NUMBER 0011040 WAS PERFORMED AND BASED ON THE INVESTIGATION NO DEFECTS WERE IDENTIFIED WITH THE ACCESSORY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    320863 PENTAX SINGLE USE DISTAL END CAP WITH ELEVATOR FDT HOYA CORPORATION PENTAX TOKYO OFFICE OE-A63 0011040

    Patients

    Seq Age Sex Outcome Treatment
    1 Other