BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROX ACCESS 55MM ART STAP THIC

    MDR report key: 2150415 · Received July 6, 2011

    Report

    Report Number
    3005075853-2011-02762
    Event Type
    Malfunction
    Date Received
    July 6, 2011
    Date of Event
    May 10, 2011
    Report Date
    May 10, 2011
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K020779
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DAMAGED OR MISSING CLOSURE LINK THE ANALYSIS RESULTS SHOWED THAT DEVICE (A) ARRIVED WITH THE CLOSING MECHANISM DAMAGED AND FULLY LOADED WITH STAPLES. NO FUNCTIONAL TEST WAS PERFORMED DUE TO THE CONDITION OF THE DEVICE AS THE CLOSURE LINK WAS FOUND DAMAGED. WHILE NO CONCLUSION COULD BE REACHED AS TO HOW THE CLOSURE LINK BECAME DAMAGED, IT SHOULD BE NOTED THAT A 100% INSPECTIONS TAKES PLACE DURING MANUFACTURING TO ENSURE THE DEVICE MEETS THE REQUIRED SPECIFICATIONS. IN ADDITION, A SAMPLE OF THE BATCH IS INSPECTED AT (B)(4). A BATCH RECORD REVIEW WAS PERFORMED AND NO ANOMALIES WERE FOUND DURING THE MANUFACTURING PROCESS.

    Additional Manufacturer Narrative · 1

    (B)(4). (DAMAGED OR MISSING CLOSURE LINK)- CONCLUSIONS: DEVICE (B) ARRIVED WITH THE CLOSING MECHANISM DAMAGED AND FULLY LOADED WITH STAPLES. NO FUNCTIONAL TEST WAS PERFORMED DUE TO THE CONDITION OF THE DEVICE AS THE CLOSURE LINK WAS FOUND DAMAGED. WHILE NO CONCLUSION COULD BE REACHED AS TO HOW THE CLOSURE LINK BECAME DAMAGED, IT SHOULD BE NOTED THAT A 100% INSPECTION TAKES PLACE DURING MANUFACTURING TO ENSURE THE DEVICE MEETS THE REQUIRED SPECIFICATIONS. IN ADDITION, A SAMPLE OF THE BATCH IS INSPECTED AT (B)(4). A BATCH RECORD REVIEW WAS PERFORMED AND NO ANOMALIES WERE FOUND DURING THE MANUFACTURING PROCESS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING LOW ANTERIOR RESECTION PROCEDURE, THE SURGEON PLACED THE AX55G ACROSS THE COLON AND TRIED TO CLOSE THE DEVICE AND THE DEVICE BROKE; THEY THEN TRIED A (B)(4) DEVICE AND THEY COULD NOT GET THE TISSUE IN PARALLEL TO PROPERLY CLOSE THE DEVICE. THEY THEN TRIED AN (B)(4) WITH A (B)(4) GREEN RELOAD AND WHEN IT CLOSED ON THE TISSUE IT WAS MILKING THE TISSUE AND DID NOT FIRE THE DEVICE. THEY REMOVED THE DEVICE AND TRIED TO USE A SECOND AX55G DEVICE AND IT BROKE WHEN THEY TRIED TO CLOSE THE DEVICE. THE SURGEON NOW DECIDED TO USE A (B)(4) DEVICE WITH (B)(4) RELOADS; WITH THE FIRST AND SECOND RELOAD, THE DEVICE WOULD NOT CLOSE; THE THIRD RELOAD FIRED AND HE COMPLETED THE PROCEDURE BY HAND SEWN END-TO-END ANASTOMOSIS THERE WAS NO PATIENT CONSEQUENCE REPORTED. THE SIGMOID COLON OF THE PATIENT WAS VERY LARGE AND THE TISSUE WAS THICK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROX ACCESS 55MM ART STAP THIC STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR