BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOL ML 5 MILLIMETER ENDO APPLIER

    MDR report key: 8992930 · Received September 11, 2019

    Report

    Report Number
    3011137372-2019-00305
    Event Type
    Malfunction
    Date Received
    September 11, 2019
    Date of Event
    August 14, 2019
    Report Date
    August 25, 2019
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    GDO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). PER INFORMATION PROVIDED FROM CUSTOMER THE OHR FOR THE ALLEGED NSTRUIMENT WAS REVIEWED AND FOUND COMPLETE WITHOUT ANY IRREGULARITIES. THE ALLEGED INSTRUMENT WAS PRODUCED AT THE TECOMET, INC KENOSHA WI FACILITY AS PART OF A 50 PC. LOT (B)(6) 2018. THIS INSTRUMENT HAS NOT BEEN RETURNED FOR EVALUATION AND INVESTIGATION THEREFORE WE ARE UNABLE TO DETERMINE WHAT CAUSED THE ALLEGED DEFECT OR VALIDATE THE ALLEGED COMPLAINT. ALL 50 INSTRUMENTS FROM THIS LOT WERE 100% VISUALLY INSPECTED AND FUNCTION TESTED PRIOR TO SHIPMENT 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 JAW WAS FOUND NOT ALIGNED DURING USAGE ON PATIENT.

    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 JAW WAS FOUND NOT ALIGNED DURING USAGE ON PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    793862 HOL ML 5 MILLIMETER ENDO APPLIER APPLIER, SURGICAL, CLIP GDO TELEFLEX MEDICAL 06A1863119

    Patients

    Seq Age Sex Outcome Treatment
    1