BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOL ML 5MM ENDO APPLIER

    MDR report key: 11003892 · Received December 14, 2020

    Report

    Report Number
    3011137372-2020-00274
    Event Type
    Malfunction
    Date Received
    December 14, 2020
    Date of Event
    November 20, 2020
    Report Date
    November 26, 2020
    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 WI FACILITY AS PART OF A 50 PC. LOT IN FEBRUARY OF 2020. EVALUATION OF THE RETURNED DEVICE SHOWS THAT THE TIPS ARE SLIGHTLY LOOSE AND MISALIGNED TO EACH OTHER IN THE CLOSED POSITION AND THE JAW PIVOT PIN IN SLIGHTLY PULLED THRU ONE SIDE OF THE OUTER TUBE ASSEMBLY THEREFORE WE ARE ABLE TO VALIDATE THIS COMPLAINT. THIS INSTRUMENT WAS DIS-ASSEMBLED IN ORDER TO EVALUATE ITS INTERNAL COMPONENTS AND IT WAS FOUND THAT THE DRIVE ROD (N00185) FINGERS THAT ACTUATE THE JAWS WERE DAMAGED. WE SUSPECT THAT THE DAMAGED DRIVE ROD FINGERS CAUSED THE JAWS TO BECOME SLIGHTLY LOOSE AND MISALIGNED IN THE CLOSED POSITION. WE ARE UNABLE TO DETERMINE WHAT CAUSED THE DRIVE ROD FINGERS TO BECOME 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE USER FOUND MISALIGNMENT OF THE JAWS DURING USE. ALSO, THE PIVOT PIN GOT LOOSE. THEREFORE, THE APPLIER WAS REPLACED WITH ANOTHER ONE. IT WAS PURCHASED BY THE HOSPITAL IN (B)(6) 2020.

    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 USER FOUND MISALIGNMENT OF THE JAWS DURING USE. ALSO, THE PIVOT PIN GOT LOOSE. THEREFORE, THE APPLIER WAS REPLACED WITH ANOTHER ONE. IT WAS PURCHASED BY THE HOSPITAL IN (B)(6) 2020.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1467885 HOL ML 5MM ENDO APPLIER APPLIER, SURGICAL, CLIP GDO TELEFLEX MEDICAL 06F1989606

    Patients

    Seq Age Sex Outcome Treatment
    1