BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOL ML 5MM ENDO APPLIER

    MDR report key: 13951866 · Received March 30, 2022

    Report

    Report Number
    3011137372-2022-00051
    Event Type
    Malfunction
    Date Received
    March 30, 2022
    Date of Event
    February 28, 2022
    Report Date
    March 15, 2022
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    GDO
    UDI-DI
    24026704696813
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SN
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THE DEVICE HAS NOT BEEN RETURNED FOR INVESTIGATION.

    Additional Manufacturer Narrative · 0

    (B)(4). PER CUSTOMER PROVIDED INFORMATION THE DHR FOR THE ALLEGED INSTRUMENT WAS REVIEWED AND FOUND COMPLETELY WITHOUT ANY IRREGULARITIES. THE ALLEGED INSTRUMENT WAS PRODUCED AT THE TECOMET, INC. KENOSHA WI FACILITY AS PART OF A 50 PC. LOT IN SEPTEMBER OF 2019. THIS INSTRUMENT HAS NOT BEEN RETURNED FOR REVIEW OR EVALUATION THEREFORE WE ARE UNABLE TO DETERMINE WHAT MAY HAVE 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 THE CUSTOMER AS THIS IS A STANDARDIZED PROCEDURE AT THIS FACILITY FOR THIS PRODUCT LINE. DUE TO THESE FINDINGS, NO FURTHER ACTIONS WILL BE TAKEN IN RESPONSE TO THIS COMPLAINT AND THIS RECORD WILL BE DEEMED CLOSED.

    Description of Event or Problem · 0

    ST. LUKE'S MEDICAL CENTER (B)(4) BRANCH COMPLAINS THAT NEWLY USED, LESS THAN 3 MONTHS, HEMLOCK ML ENDO APPLIERS GET EASILY MISALIGNED. THIS COMPLAINT IS AN ADDITIONAL TO THEIR PREVIOUS REPORTS OF THE SAME QUALITY ISSUE, 9 EA OF HOL ML ENDO APPLIERS MISALIGNED JAWS AS PREVIOUSLY REPORTED. ACCORDING TO THEIR OBSERVATION, APPLIERS BOUGHT 2016 ONWARDS HAS THE SAME PROBLEM COMPARED TO EARLIER THAN 2015 APPLIERS.

    Description of Event or Problem · 0

    (B)(6) MEDICAL CENTER - QUEZON CITY BRANCH COMPLAINS THAT NEWLY USED, LESS THAN 3 MONTHS, HEMLOCK ML ENDO APPLIERS GET EASILY MI SALIGNED. THIS COMPLAINT IS AN ADDITIONAL TO THEIR PREVIOUS REPORTS OF THE SAME QUALITY ISSUE, 9 EA OF HOL ML ENDO APPLIERS MISALIGNED JAWS AS PREVIOUSLY REPORTED. ACCORDING TO THEIR OBSERVATION, APPLIERS BOUGHT 2016 ONWARDS HAS THE SAME PROBLEM COMPARED TO EARLIER THAN 2015 APPLIERS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    782787 HOL ML 5MM ENDO APPLIER APPLIER, SURGICAL, CLIP GDO TELEFLEX MEDICAL IPN915189 06C1985935 24026704696813

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown