BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEMOLOK TAKEAPART ML 5MM ENDO APPLIER

    MDR report key: 18467543 · Received January 8, 2024

    Report

    Report Number
    3011137372-2024-00008
    Event Type
    Malfunction
    Date Received
    January 8, 2024
    Date of Event
    December 13, 2023
    Report Date
    December 15, 2023
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    GDO
    UDI-DI
    24026704697841
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    QN# (B)(4). THE SAMPLE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION. THE MANUFACTURER REPORTED:" DURING VISUAL AND FUNCTIONAL EXAMINATION WE FOUND THE FOLLOWING: WE HAVE TRIED THE FUNCTION OF THE MOUTH MANY TIMES WITHOUT/WITH TEST MATERIAL AND COULD NOT FIND ANY ERROR. THE CLIP WAS EASY TO ATTACH AND CLOSED NEATLY. UPON REVIEW OF THE DEVICE HISTORY RECORDS FOR THE AFFECTED LOT NUMBER, WE CAN CONFIRM THAT BOTH THE CORRECT MATERIAL AND CORRECT COMPONENTS HAD BEEN USED AND THAT THE INSTRUMENT MEETS THE PRODUCT SPECIFICATIONS. ALL PROCESS STEPS WERE FOUND TO HAVE BEEN PROPERLY DOCUMENTED. 100% FUNCTIONAL TEST AT FINAL INSPECTION FOUND GOOD. NO DYSFUNCTION WAS DETECTED. AT K & W, NO FURTHER MEASURES WILL BE INITIATED." TELEFLEX WILL CONTINUE TO MONITOR AND TREND FOR REPORTS OF THIS NATURE.

    Additional Manufacturer Narrative · 0

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

    Description of Event or Problem · 0

    IT WAS REPORTED THAT "THE USER ATTEMPTED TO LIGATE A CLIP IN THE PATIENT'S ABDOMINAL CAVITY DURING A SURGERY, BUT THE CLIP WAS NOT LOCKED. THEREFORE, THE APPLIER WAS REPLACED WITH A NEW ONE TO COMPLETE THE PROCEDURE". NO PATIENT HARM OR INJURY. THE PATIENT STATUS IS REPORTED AS "FINE".

    Description of Event or Problem · 0

    IT WAS REPORTED THAT "THE USER ATTEMPTED TO LIGATE A CLIP IN THE PATIENT'S ABDOMINAL CAVITY DURING A SURGERY, BUT THE CLIP WAS NOT L OCKED. THEREFORE, THE APPLIER WAS REPLACED WITH A NEW ONE TO COMPLETE THE PROCEDURE". NO PATIENT HARM OR INJURY. THE PATIENT STATUS IS REPORTED AS "FINE".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    987379 HEMOLOK TAKEAPART ML 5MM ENDO APPLIER APPLIER, SURGICAL, CLIP GDO TELEFLEX MEDICAL M32243276 24026704697841

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown