BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOL ML 5MM ENDO APPLIER

    MDR report key: 13342424 · Received January 25, 2022

    Report

    Report Number
    3011137372-2022-00007
    Event Type
    Malfunction
    Date Received
    January 25, 2022
    Date of Event
    January 12, 2022
    Report Date
    January 12, 2022
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    GDO
    UDI-DI
    24026704696813
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THE DEVICE HAS NOT BEEN RETURNED FOR INVESTIGATION. TELEFLEX WILL CONTINUE TO MONITOR AND TREND RELATED EVENTS.

    Additional Manufacturer Narrative · 0

    QN# (B)(4). THE DHR FOR THE RETURNED INSTRUMENT WAS REVIEWED AND FOUND COMPLETELY WITHOUT ANY IRREGULARITIES. THIS INSTRUMENT WAS PRODUCED AT THE TECOMET, INC. KENOSHA WI FACILITY AS PART OF A 50 PC. LOT IN JULY OF 2021. EVALUATION OF THE RETURNED INSTRUMENT SHOWS THAT THE TIPS ARE LOOSE AND MISALIGNED, AND THE JAW PIVOT PIN IS PUSHED THRU ONE SIDE OF THE DAMAGED/BENT OUTER TUBE ASSEMBLY. WE ARE ABLE TO VALIDATE THIS COMPLAINT. AFTER THE INITIAL EVALUATION THIS INSTRUMENT WAS DIS-ASSEMBLED IN ORDER TO EVALUATE ITS INTERNAL COMPONENTS AND IT WAS FOUND THAT THE INNER DRIVE ROD (N00185) IS BENT/DAMAGED , AND ITS BOSSES ARE BOTH DAMAGED WHERE THEY ENGAGE THE JAWS. WE ARE UNABLE TO DETERMINE WHAT CAUSED THE TIPS TO BE LOOSE AND MISALIGNED, AND THE JAW PIVOT PIN IS PUSHED THRU ONE SIDE OF THE DAMAGED/BENT OUTER TUBE ASSEMBLY AND FOR THE DRIVE ROD AND IT'S BOSSED TO BECOME BENT/DAMAGED BUT MISHANDLING OF THIS DEVICE AT THE END USER'S FACILITY IS SUSPECTED. ALL 50 INSTRUMENTS FROM THIS LOT WERE 100% VISUALLY INSPECTED AND FUNCTION TESTED PRIOR TO SHIPMENT TO THE CUSTOMER AS THIS IS A STANDARDIZED PROCEDURE AT THIS FACILITY FOR THIS PRODUCT LINE. DUE TO THESE FINDINGS, NO FURTHER ACTIONS WILL BE TAKEN IN RESPONSE TO THIS COMPLAINT AND THIS RECORD WILL BE DEEMED CLOSED.

    Description of Event or Problem · 0

    THE PIVOT PIN GOT DETACHED DURING USE. THEREFORE, A NEW UNIT WAS USED INSTEAD. THE APPLIER WAS PURCHASED BY THE HOSPITAL WITHIN 1 YEAR.

    Description of Event or Problem · 0

    THE PIVOT PIN GOT DETACHED DURING USE. THEREFORE, A NEW UNIT WAS USED INSTEAD. THE APPLIER WAS PURCHASED BY THE HOSPITAL WITHIN 1 YEAR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    663085 HOL ML 5MM ENDO APPLIER APPLIER, SURGICAL, CLIP GDO TELEFLEX MEDICAL IPN915189 06E2002042 24026704696813

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown