BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROXIMATE** RELOADABLE LINEAR CUTTER WITH SAFTEY LOCK-OUT

    MDR report key: 1873385 · Received October 19, 2010

    Report

    Report Number
    3005075853-2010-05924
    Event Type
    Malfunction
    Date Received
    October 19, 2010
    Date of Event
    September 13, 2010
    Report Date
    September 24, 2010
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K020779
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INCOMPLETE/INTERRUPTED CYCLE THE ANALYSIS RESULTS FOUND THAT THE DEVICE WAS RECEIVED IN GOOD VISUAL CONDITIONS AND WITH TWO CARTRIDGE RELOADS PRESENT. CARTRIDGE A HAD THE PROXIMAL 25 DRIVERS UP WITHOUT STAPLES, AND THE REMAINING DRIVERS DOWN WITH STAPLES PRESENT. RELOAD B WAS RECEIVED WITH 32 DRIVERS UP. THE RETURNED CARTRIDGE RELOADS HAD THE SWING TABS IN THE LOCKED POSITION, WHICH INDICATES THAT THE DEVICE'S FIRING CYCLE WAS INTERRUPTED. IT SHOULD BE NOTED THAT THE CARTRIDGE RELOAD IS DESIGNED TO LOCKOUT, AS A SAFETY FEATURE, IF ANY STAPLES HAVE BEEN FIRED FROM THE CARTRIDGE RELOAD. IN ADDITION, FAILURE TO COMPLETE THE STROKE MAY RESULT IN AN INCOMPLETE STAPLE LINE. FOR ADDITIONAL INFORMATION, PLEASE REFER TO THE INSTRUCTIONS FOR USE. THE RETURNED CARTRIDGE RELOADS A AND B, WERE MANUALLY UNLOCKED AND THE DEVICE WAS TESTED FOR FUNCTIONALITY WITH THE RETURNED CARTRIDGE RELOADS AND THE DEVICE FIRED, CUT, AND FORMED ALL THE REMAINING STAPLES AS INTENDED. THE DEVICE FIRED WITH NO DIFFICULTIES AND THE STAPLES WERE NOTED TO HAVE THE PROPER B-FORMED SHAPE. 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 LAPAROTOMY, THE STAPLES FELL OUT. THE PROCEDURE WAS PERFORMED ON A RECTAL CARCINOMA BY LAPAROTOMY, ON A CORPULENT PATIENT (DIFFICULT ACCESS). THE PROCEDURE WAS FINALLY PERFORMED WITH A COMPETITOR DEVICE. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT.

    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. G4TF1E

    Patients

    Seq Age Sex Outcome Treatment
    1 RELOAD - (B)(4)