BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROXIMATE** RELOADABLE LINEAR CUTTER WITH SAFTEY LOCK-OUT

    MDR report key: 1932687 · Received December 20, 2010

    Report

    Report Number
    3005075853-2010-07242
    Event Type
    Malfunction
    Date Received
    December 20, 2010
    Date of Event
    December 2, 2010
    Report Date
    December 6, 2010
    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
    KS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). SWING TAB DETACHED/MISSING. THE ANALYSIS RESULTS FOUND THAT THE RELOAD WAS RECEIVED WITH THE TWO MOST PROXIMAL DRIVERS UP AND THE SWING TAB DETACHED, MAKING THE RELOAD NONFUNCTIONAL. THE DEVICE WAS TESTED FOR FUNCTIONALITY WITH A TEST RELOAD AND IT FIRED, CUT AND FORMED ALL THE STAPLES AS INTENDED. THE DEVICE FIRED AND CUT WITHOUT ANY DIFFICULTIES, THE STAPLE LINE WAS COMPLETE, THE CUT LINE WAS COMPLETE AND THE STAPLES WERE NOTED TO HAVE THE PROPER B-FORMED SHAPE. ALTHOUGH NO CONCLUSION COULD BE REACHED ON WHAT CAUSED THE SWING TAB TO DETACH, IT SHOULD BE NOTED THAT EACH RELOAD IS 100% INSPECTED THROUGH AN AUTOMATED VISION SYSTEM TO ENSURE THAT THE SWING TAB IS PRESENT AND IN THE CORRECT POSITION PRIOR TO SHIPMENT. EVENT COULD NOT BE CONFIRMED AS THE DEVICE OPENED AS INTENDED. A BATCH RECORD REVIEW WAS PERFORMED AND NO ANOMALIES WERE FOUND DURING THE MANUFACTURING PROCESS.

    Additional Manufacturer Narrative · 1

    (B)(4): INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PROCEDURE, THE SURGEON WAS PREPARING TO OPEN THE DEVICE TO USE ON THE PATIENT AND IT WOULD NOT OPEN. A NEW DEVICE WAS USED TO CONTINUE THE PROCEDURE. THERE WAS NO PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROXIMATE** RELOADABLE LINEAR CUTTER WITH SAFTEY LOCK-OUT STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 CARTRIDGE