BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RELIATACK

    MDR report key: 8434249 · Received March 19, 2019

    Report

    Report Number
    1219930-2019-01627
    Event Type
    Malfunction
    Date Received
    March 19, 2019
    Date of Event
    February 21, 2019
    Report Date
    April 30, 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
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    EVALUATION SUMMARY: POST MARKET VIGILANCE (PMV) LED AN EVALUATION OF ONE DEVICE. THE VISUAL INSPECTION NOTED NO ABNORMALITIES. TWO FULLY APPLIED 5R DEVICE LOADING UNIT (DLU)S WERE RECEIVED. ONE NOTED PROPER TIMING AND ONE NOTED DISRUPTED TIMING. ONE 5R DLU WITH PROPER TIMING AND A FULL COMPLEMENT OF TACKS WAS RECEIVED. SCRATCHES WERE NOTED ON THE INNER TUBE OF ALL THREE DLUS. THE ARTICULATION KNOB FUNCTIONED PROPERLY. THE RETURNED DLU COULD BE LOADED ONTO THE RETURNED DEVICE. ALL FIVE TACKS DEPLOYED AND SEATED PROPERLY IN THE TEST MEDIA. 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 DLU INDICATED BY THE SCRATCHES ON THE INNER TUBE OF THE DLU. 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, DURING ABDOMINAL WALL HERNIA PROCEDURE, THERE WAS NO PROBLEM UNTIL THE SECOND CARTRIDGE. IT WAS STATED THAT WHEN TRYING TO PUT CARTRIDGE OUT OF THE PORT, THE CARTRIDGE SUDDENLY DISENGAGED FROM THE TACKER ALTHOUGH IT WAS NOT IN REMOVAL OR ATTACHMENT MODE. THE PART FELL INTO THE PATIENT'S CAVITY AND WAS RETRIEVED WITH FORCEPS. ANOTHER FIVE TACKS CARTRIDGE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    226532 RELIATACK STAPLE, IMPLANTABLE GDW COVIDIEN LP LLC NORTH HAVEN RELTACK3X10 8198036NH 10884521202399

    Patients

    Seq Age Sex Outcome Treatment
    1