BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOL ML 5MM ENDO APPLIER

    MDR report key: 11693587 · Received April 20, 2021

    Report

    Report Number
    3011137372-2021-00119
    Event Type
    Malfunction
    Date Received
    April 20, 2021
    Date of Event
    April 7, 2021
    Report Date
    April 7, 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 50 PC. LOT IN MARCH OF 2020. 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 OUTER TUBE ASSEMBLY. WE ARE ABLE TO VALIDATE THIS COMPLAINT. AFTER THE INITIAL EVALUATION THIS INSTRUMENT WAS DISASSEMBLED IN ORDER TO EVALUATE ITS INTERNAL COMPONENTS AND IT WAS FOUND THAT THE INNER DRIVE ROD (N00-185) FINGERS ARE BOTH DARM:1YED WHERE T11EY ENGAGE TILE JAWS. MISHANDLING OF THIS DEVICE AT THE END USER'S FACILITY IS SUSPECTED.

    Description of Event or Problem · 0

    THE JAWS OF THE APPLIER WAS MISALIGNED SO THAT IT WAS UNABLE TO LOAD A CLIP DURING A PRETEST. ALSO, THE PIVOT PIN WAS LOOSE. THEREFORE, ANOTHER APPLIER WAS USED INSTEAD. THE APPLIER WAS PURCHASED BY THE HOSPITAL WITHIN 1 YEAR.

    Additional Manufacturer Narrative · 1

    QN#: (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

    THE JAWS OF THE APPLIER WAS MISALIGNED SO THAT IT WAS UNABLE TO LOAD A CLIP DURING A PRETEST. ALSO, THE PIVOT PIN WAS LOOSE. THEREFORE, ANOTHER APPLIER WAS USED INSTEAD. THE APPLIER WAS PURCHASED BY THE HOSPITAL WITHIN 1 YEAR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    594964 HOL ML 5MM ENDO APPLIER APPLIER, SURGICAL, CLIP GDO TELEFLEX MEDICAL IPN915189 06F1989610 24026704696813

    Patients

    Seq Age Sex Outcome Treatment
    1