BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RELIATACK

    MDR report key: 8260695 · Received January 18, 2019

    Report

    Report Number
    1219930-2019-00364
    Event Type
    Malfunction
    Date Received
    January 18, 2019
    Date of Event
    December 20, 2018
    Report Date
    March 25, 2019
    Manufacturer
    COVIDIEN LP LLC NORTH HAVEN
    Product Code
    GDW
    UDI-DI
    10884521202399
    PMA / PMN Number
    K140609
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    EVALUATION SUMMARY: POST MARKET VIGILANCE (PMV) LED AN EVALUATION OF ONE DEVICE. A VISUAL INSPECTION OF THE RETURNED PRODUCT NOTED THE TIMING WAS DISRUPTED. ONE FULLY APPLIED 5R SINGLE UNIT LOADING UNIT (SULU) WAS RECEIVED PRELOADED ON THE DEVICE. SCRATCHES WERE NOTED ON THE INNER TUBE OF THE SULU. A FUNCTIONAL EVALUATION FOUND THAT THE ARTICULATION KNOB FUNCTIONED PROPERLY. THE RETURNED SULU WAS UNLOADED FROM THE RETURNED DEVICE. THE HANDLE WAS ACTUATED AND THE CYCLED PROPERLY WITH NO SULU ATTACHED. A TEST SULU WAS UNABLE TO BE LOADED ONTO THE INSTRUMENT DUE TO DISRUPTED TIMING OF THE DEVICE. RECORDS FROM EACH MANUFACTURING LOT ARE THOROUGHLY REVIEWED TO ENSURE THAT PRODUCTS ARE RELEASED MEETING ALL QUALITY RELEASE SPECIFICATIONS AT THE TIME OF MANUFACTURE. REPLICATION OF THE REPORTED CONDITION COULD BE DUE TO EXCESSIVE MANIPULATION OR TO IMPROPER LOADING OF THE SULU. THE ROOT CAUSE OF THE OBSERVED DAMAGE WAS MISUSE OF THE PRODUCT WHICH CAUSED OR CONTRIBUTED TO THE REPORTED CONDITION. NO FURTHER ACTIONS HAVE BEEN DEEMED NECESSARY AT THIS TIME. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER, PRIOR A LAPAROSCOPIC INGUINAL HERNIA PROCEDURE, THERE WERE DIFFICULTIES WITH LOADING THE RELOAD ONTO THE HANDLE, DIFFICULTY IN PRESSING THE "PUSH TO RELOAD" BUTTON, AND DIFFICULTY WITH NAVIGATING THE LOCK AND UNLOCK BUTTON. AFTER THE LOADING ISSUES WERE EXPERIENCED, THE RELOAD WAS NOT USED BY THE PATIENT. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    53068 RELIATACK STAPLE, IMPLANTABLE GDW COVIDIEN LP LLC NORTH HAVEN RELTACK3X10 N7E0834UX 10884521202399

    Patients

    Seq Age Sex Outcome Treatment
    1