BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOL ML 5 MILLIMETER ENDO APPLIER

    MDR report key: 9165927 · Received October 8, 2019

    Report

    Report Number
    3011137372-2019-00365
    Event Type
    Malfunction
    Date Received
    October 8, 2019
    Date of Event
    September 20, 2019
    Report Date
    October 1, 2019
    Product Code
    GDO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    QN#(B)(4). PER INFORMATION PROVIDED FROM CUSTOMER THE OHR FOR THE ALLEGED DEVICE WAS REVIEWED AND FOUND COMPLETELY WITHOUT ANY IRREGULARITIES. THIS INSTRUMENT WAS PRODUCED AS PART OF A 50 PC. LOT IN (B)(6)2017. THIS INSTRUMENT HAS NOT BEEN RETURNED FOR REVIEW OR EVALUATION THEREFORE WE ARE UNABLE TO DETERMINE WHAT MIGHT HAVE CAUSED THE INSTRUMENT TO BE MISALIGNED AND TO NOT CLOSE THE CLIPS AND UNABLE TO VALIDATE THE ALLEGED COMPLAINT. ALL (B)(4) INSTRUMENTS FROM THIS LOT WERE 100% VISUALLY INSPECTED AND FUNCTION TESTED PRIOR TO RELEASE TO 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 APPLIER IS MISALIGNED AND IS NOT CLOSING THE PROPER WAY TO SECURE THE CLIP.

    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 APPLIER IS MISALIGNED AND IS NOT CLOSING THE PROPER WAY TO SECURE THE CLIP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    961821 HOL ML 5 MILLIMETER ENDO APPLIER APPLIER, SURGICAL, CLIP GDO 06C1749066

    Patients

    Seq Age Sex Outcome Treatment
    1