BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROXIMATE RELOADABLE LINEAR STAPLER

    MDR report key: 1181730 · Received September 30, 2008

    Report

    Report Number
    3005075853-2008-01987
    Event Type
    Malfunction
    Date Received
    September 30, 2008
    Date of Event
    September 3, 2008
    Report Date
    September 4, 2008
    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
    SW
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE ANALYSIS RESULTS SHOWED THAT THE DEVICE ARRIVED IN GOOD VISUAL CONDITION AND WITH A CARTRIDGE LOADED ON THE DEVICE. THE CARTRIDGE WAS RETURNED VOID OF STAPLES. THE DEVICE WAS TESTED FOR FUNCTIONALITY WITH A TEST CARTRIDGE AND IT CYCLED, FIRED, AND ALL THE STAPLES FORMED AS INTENDED. THE DEVICE FIRED WITHOUT ANY DIFFICULTIES AND THE STAPLES WERE NOTED TO HAVE THE PROPER B-FORMED SHAPE. IT IS POSSIBLE THAT AN INADVERTENT MOVEMENT OF THE FIRING TRIGGER AFTER DISENGAGING THE SAFETY MIGHT HAVE CAUSED THE STAPLES TO FALL OUT. IT IS IMPORTANT TO ENSURE THAT THE TISSUE IS SECURED WITH THE RETAINING PIN AND THE ADJUSTING KNOB IS SET IN THE FIRING RANGE BEFORE DISENGAGING THE SAFETY. THEREFORE, IT IS IMPERATIVE THAT DISENGAGING THE SAFETY BE THE LAST STEP PRIOR TO FIRING. IN ADDITION, COMPLAINT INFORMATION IS TRENDED ON A REGULAR BASIS TO DETERMINE IF FURTHER INVESTIGATION IS WARRANTED. 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 A ULCERUS COLITIS, LAR PROCEDURE, THE SURGEON WAS GOING TO STAPLE THE RECTUM LOW DOWN IN THE PELVIS, PERFORMING A COLON RESECTION DUE TO ULCERUS COLITIS. THE SURGEON PROCEEDED TO PLACE THE DEVICE AND DIALED DOWN ON THE DEVICE UNTIL IT WAS "IN THE GREEN ABOUT HALF WAY DOWN THE SCALE". HE THEN CONTINUED TO FIRE THE DEVICE, AND AFTER THAT CUT OF THE RECTUM PROXIMAL. THE MALFUNCTION WAS NOT DISCOVERED IMMEDIATELY, BUT BECAME EVIDENT WHEN THE ASSISTANT SURGEON PUT HIS FINGER UP THE RECTUM TO CHECK ON THE ANASTOMOSIS. IT WENT STRAIGHT THROUGH. THEY EXAMINED THE AREA AND COULD NOT FIND ANY TRACES OF STAPLES IN OR AROUND THE RECTUM OR IN THE PELVIS AND CONCLUDED THAT THE INSTRUMENT HAD BEEN EMPTY WHEN FIRED. THEY SUTURED THE ANASTOMOSIS BY HAND, WHICH CAUSED THE OP TIME TO GO UP TO 6 HOURS INSTEAD OF 3 HOURS. THE OPERATION WAS COMPLETED WITHOUT ANY FURTHER INCIDENTS, AND THE PATIENT WAS 24 HOURS AFTER OPERATION RECOVERING AS EXPECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROXIMATE RELOADABLE LINEAR STAPLER GDW ETHICON ENDO-SURGERY, LLC NA E4KF6A

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR