BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOL ML 5MM ENDO APPLIER

    MDR report key: 17418056 · Received July 28, 2023

    Report

    Report Number
    3011137372-2023-00196
    Event Type
    Malfunction
    Date Received
    July 28, 2023
    Date of Event
    July 4, 2023
    Report Date
    July 11, 2023
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    GDO
    UDI-DI
    24026704696813
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THE DEVICE WAS RETURNED AND SENT TO THE MANUFACTURING SITE (TECOMET) FOR INVESTIGATION. TECOMET REPORTS "THE DHR FOR THE RETURNED INSTRUMENT WAS REVIEWED AND FOUND COMPLETE WITHOUT ANY IRREGULARITIES. THIS INSTRUMENT WAS PRODUCED AT THE TECOMET, INC. KENOSHA WI FACILITY AS PART OF A (B)(4). LOT IN MARCH OF 2022. IT WAS FOUND THAT THIS ORDER WAS MADE FROM THE CORRECT MATERIALS AND COMPONENTS AND ALL APPROVED PROCESSES WERE FOLLOWED. EVALUATION OF THE RETURNED INSTRUMENT SHOWS THAT THE JAWS ARE LOOSE AND MISALIGNED AND BENT TOWARDS THE LEFT, AND THE JAW PIVOT PIN IS PULLED THRU ONE SIDE OF THE BENT/DAMAGED OUTER TUBE ASSEMBLY. WE ARE ABLE TO VALIDATE THE COMPLAINT FOR THE RETURNED INSTRUMENT. AFTER THE INITIAL EVALUATION THIS INSTRUMENT WAS DIS-ASSEMBLED IN ORDER TO EVAL UATE ITS INTERNAL COMPONENTS AND IT WAS FOUND THAT ONE OF THE INNER DRIVE ROD (N00185) BOSSES IS DAMAGED WHERE IT ENGAGES THE JAWS. WE SUSPECT THAT THE DAMAGED DRIVE ROD BOSS CAUSED THE JAWS TO BECOME SLIGHTLY LOOSE AND MISALIGNED IN THE CLOSED POSITION. WE ARE UNABLE TO DETERMINE WHAT CAUSED THE DRIVE ROD BOSS TO BECOME DAMAGED AND FOR THE JAW PIVOT PIN TO BE PULLED THRU ONE SIDE OF THE BENT/DAMAGED OUTER TUBE ASSEMBLY BUT MISHANDLING OF THIS DEVICE AT THE END USER'S FACILITY IS SUSPECTED.

    Additional Manufacturer Narrative · 0

    QN#(B)(4). OTHER REMARKS: N/A. CORRECTED DATA: N/A.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT "THE JAWS OF THE APPLIER GOT BENT AND THE PIVOT PIN GOT DETACHED FROM THE APPLIER DURING USE. THEREFORE, THE APPLIER WAS REPLACED WITH A NEW ONE TO COMPLETE THE PROCEDURE. NOTHING FELL/REMAINED IN THE PATIENT AND NO PATIENT INJURY OCCURRED". THE PATIENT STATUS IS REPORTED AS "FINE".

    Description of Event or Problem · 0

    IT WAS REPORTED THAT "THE JAWS OF THE APPLIER GOT BENT AND THE PIVOT PIN GOT DETACHED FROM THE APPLIER DURING USE. THEREFORE, THE APPLIER WAS REPLACED WITH A NEW ONE TO COMPLETE THE PROCEDURE. NOTHING FELL/REMAINED IN THE PATIENT AND NO PATIENT INJURY OCCURRED". THE PATIENT STATUS IS REPORTED AS "FINE".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1946285 HOL ML 5MM ENDO APPLIER APPLIER, SURGICAL, CLIP GDO TELEFLEX MEDICAL 06A2244654 24026704696813

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown