BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOL ML 5MM ENDO APPLIER

    MDR report key: 11686597 · Received April 19, 2021

    Report

    Report Number
    3011137372-2021-00100
    Event Type
    Malfunction
    Date Received
    April 19, 2021
    Date of Event
    December 23, 2020
    Report Date
    April 1, 2021
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    GDO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    RISK MANAGER

    Narratives

    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 2019. EVALUATION OF THE RETURNED INSTRUMENT SHOWS THAT THE JAWS ARE LOOSE AND MISALIGNED , AND THE JAW PIVOT PIN IS PUSHED OUT ON ONE SIDE OF THE DAMAGED 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 AND ITS FINGERS ARE BOTH DAMAGED WHERE THEY ENGAGE THE JAWS. 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.

    Description of Event or Problem · 0

    WHEN THE USER ATTEMPTED TO USE THE APPLIER DURING A SURGERY, IT DID NOT WORK PROPERLY. THEREFORE, HE/SHE REPLACED IT WITH A NEW ONE. THE APPLIER WAS SENT TO OUR TECHNICAL SPECIALIST, WHO FOUND THE JAWS WERE MIASLIGNED, THE PIVOT PIN WAS LOOSE AND THE SHAFT WAS DEFORMED. HE CONCLUDED IT WAS UNREPAIRABLE.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    WHEN THE USER ATTEMPTED TO USE THE APPLIER DURING A SURGERY, IT DID NOT WORK PROPERLY. THEREFORE, HE/SHE REPLACED IT WITH A NEW ONE. THE APPLIER WAS SENT TO OUR TECHNICAL SPECIALIST, WHO FOUND THE JAWS WERE MISALIGNED, THE PIVOT PIN WAS LOOSE AND THE SHAFT WAS DEFORMED. HE CONCLUDED IT WAS UNREPAIRABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    585885 HOL ML 5MM ENDO APPLIER APPLIER, SURGICAL, CLIP GDO TELEFLEX MEDICAL 06C1985913

    Patients

    Seq Age Sex Outcome Treatment
    1