BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ILS CURVED CIR STAPLER

    MDR report key: 2142571 · Received June 28, 2011

    Report

    Report Number
    3005075853-2011-02654
    Event Type
    Malfunction
    Date Received
    June 28, 2011
    Date of Event
    May 25, 2011
    Report Date
    June 1, 2011
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K983536
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME. ADDITIONAL INFORMATION WAS REQUESTED.

    Additional Manufacturer Narrative · 1

    (B)(4). DISLODGED COMPONENT. THE ANALYSIS RESULTS FOUND THAT THE INSTRUMENT ARRIVED IN GOOD VISUAL CONDITION WITHOUT STAPLES PRESENT AND WITH THE WASHER CUT. AFTER FURTHER INSPECTION, IT WAS NOTED THAT THE GUIDE FACE WAS DETACHED FROM THE DEVICE AND WAS PROTRUDING FROM THE CASING. NO FUNCTIONAL TEST WAS PERFORMED DUE TO THE CONDITION OF THE DEVICE. WHILE NO CONCLUSION COULD BE REACHED AS TO HOW THE GUIDE FACE WAS DETACHED FROM THE CASING, IT IS POSSIBLE THAT THERE WAS NOT SUFFICIENT ADHESIVE APPLIED. IT SHOULD BE NOTED THAT A 100% INSPECTION TAKES PLACE DURING MANUFACTURING TO ENSURE THE DEVICE MEETS THE REQUIRED SPECIFICATIONS PRIOR TO SHIPMENTS. 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 AN OPEN GASTRECTOMY PROCEDURE, THE DEVICE WAS USED TO ANASTOMOSE BETWEEN THE STOMACH AND THE DUODENUM. THE DEVICE COULD NOT ANASTOMOSE PROPERLY. ADDITIONAL SUTURE WAS PERFORMED BY HAND. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. WHEN THE SALES REP CHECKED THE DEVICE AFTER THE OPERATION, IT WAS FOUND THAT THE WASHER WAS UNCUT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ILS CURVED CIR STAPLER STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1