BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOL ML 5MM ENDO APPLIE

    MDR report key: 11581182 · Received March 29, 2021

    Report

    Report Number
    3011137372-2021-00065
    Event Type
    Malfunction
    Date Received
    March 29, 2021
    Date of Event
    March 5, 2021
    Report Date
    March 8, 2021
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    GDO
    UDI-DI
    24026704696813
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    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 (B)(4) PC. LOT IN APRIL OF 2020. EVALUATION OF THIS INSTRUMENT SHOWS THAT THE JAW PIVOT PIN IS SLIGHTLY STICKING OUT OF THE OUTER TUBE ASSEMBLY. FURTHER EVALUATION SHOWS THAT THE JAWS ARE MISALIGNED IN THE CLOSED POSITION. 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 DRIVE ROD (N00185) FINGERS ARE ALSO DAMAGED. IT IS SUSPECTED THAT THE DAMAGED DRIVE ROD FINGERS ARE WHAT CAUSED THE JAWS TO BECOME MISALIGNED AND FOR THE JAW PIVOT PIN TO BE SLIGHTLY STICKING OUT OF ONE SIDE OF THE OUTER TUBE ASSEMBLY. MISHANDLING OF THIS DEVICE AT THE END USER'S FACILITY IS SUSPECTED. ALL (B)(4) 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

    IT WAS REPORTED THAT THE PIVOT PIN WAS FOUND DETACHED BEFORE USE. THEREFORE, A NEW APPLIER WAS USED INSTEAD.

    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

    IT WAS REPORTED THAT THE PIVOT PIN WAS FOUND DETACHED BEFORE USE. THEREFORE, A NEW APPLIER WAS USED INSTEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    478981 HOL ML 5MM ENDO APPLIE APPLIER, SURGICAL, CLIP GDO TELEFLEX MEDICAL IPN915189 06B2098678 24026704696813

    Patients

    Seq Age Sex Outcome Treatment
    1