BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HZ APPLIER SMALL 8" CVD

    MDR report key: 8232126 · Received January 9, 2019

    Report

    Report Number
    3011137372-2019-00016
    Event Type
    Malfunction
    Date Received
    January 9, 2019
    Date of Event
    December 18, 2018
    Report Date
    December 18, 2018
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    GDO
    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 FACILITY AS PART OF A 87PC. LOT IN MARCH OF 2017. THE RETURNED INSTRUMENT WAS EVALUATED AND FOUND THAT IT PICKS UP , RETAINS , CLOSED AND RELEASES CLIPS AS REQUIRED OF ITS FUNCTION. WE ARE UNABLE TO VALIDATE THIS COMPLAINT SINCE WE ARE UNABLE TO REPLICATE THE ALLEGED ISSUE. ALL INSTRUMENTS PRODUCED AT THIS FACILITY ARE 100% VISUALLY INSPECTED AND FUNCTION TESTED PRIOR TO SHIPMENT TO CUSTOMER AS THIS IS A STANDARDIZED PROCEDURE FOR THIS PRODUCT LINE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE CLIPS WERE NOT PROPERLY LOADED INTO THE JAWS SO THAT THE USER WAS UNABLE TO LIGATE ADEQUATELY. THEREFORE, THE APPLIER WAS REPLACED WITH A NEW ONE.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE INVESTIGATION IS PENDING. TELEFLEX WILL CONTINUE TO MONITOR AND TREND RELATED EVENTS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CLIPS WERE NOT PROPERLY LOADED INTO THE JAWS SO THAT THE USER WAS UNABLE TO LIGATE ADEQUATELY. THEREFORE, THE APPLIER WAS REPLACED WITH A NEW ONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    24196 HZ APPLIER SMALL 8" CVD APPLIER, SURGICAL, CLIP GDO TELEFLEX MEDICAL 06J1640731

    Patients

    Seq Age Sex Outcome Treatment
    1