BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENTAX

    MDR report key: 15143531 · Received August 2, 2022

    Report

    Report Number
    9610877-2022-00541
    Event Type
    Malfunction
    Date Received
    August 2, 2022
    Date of Event
    March 9, 2022
    Report Date
    August 2, 2022
    Manufacturer
    HOYA CORPORATION PENTAX TOKYO OFFICE
    Product Code
    EOB
    PMA / PMN Number
    K172156
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    EVALUATION SUMMARY: INSUFFICIENT STRENGTH OF THE LASER WELDED AREA FIXING THE POSITIONING PIN IN OF-B212. THIS DEVICE IS NOT DISTRIBUTED IN US SO THAT UNIQUE IDENTIFIER IS BLANK.

    Description of Event or Problem · 0

    VNL15-J10 (A130061) WHEN I INSTALLED OF- B212 FOR CLEANING, THE PIN WAS MISSING AND IT FELL INTO THE CLEANING MACHINE (OER). AT THE TIME OF PURCHASE, THE PIN IS FIXED AND DOES NOT MOVE AND IS LOCKED, BUT IT IS NOT LOCKED BECAUSE THERE IS NO PIN. THIS EVENT OCCURRED AT THE TIME OF REPROCESSING. THERE WAS NO REPORT OF PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    358958 PENTAX CLEANING ADAPTER EOB HOYA CORPORATION PENTAX TOKYO OFFICE OF-B212

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown