BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROXIMATE RELOADABLE LINEAR STAPLER

    MDR report key: 1619017 · Received February 19, 2010

    Report

    Report Number
    3005075853-2010-00663
    Event Type
    Malfunction
    Date Received
    February 19, 2010
    Date of Event
    January 27, 2010
    Report Date
    January 27, 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
    CT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE ANALYSIS RESULT FOUND THAT THE DEVICE WAS RECEIVED IN GOOD VISUAL CONDITIONS AND WITH A RELOAD LOADED IN THE DEVICE; THE RELOAD WAS RECEIVED FULLY FIRED. IT SHOULD BE NOTED THAT AN INADVERTENT MOVEMENT OF THE FIRING TRIGGER AFTER DISENGAGING THE SAFETY MIGHT CAUSE 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. THE DEVICE WAS TESTED WITH A TEST CARTRIDGE, AND IT CYCLED, FIRED, AND FORMED ALL THE STAPLES AS INTENDED. 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 LOW ANTERIOR RESECTION, THE DEVICE WAS FIRED TO MAKE THE DISTAL TRANSECTION; THE COLON WAS THEN CUT WITH A COLD SCALPEL. NO STAPLES DEPLOYED FROM THE DEVICE. THE SCRUB PLACED THE DEVICE ON THE BACK TABLE. THE SURGEON TOOK ANOTHER DEVICE MORE DISTALLY DOWN THE RECTUM AND THE DEVICE FIRED PROPERLY. THERE WAS NO BLOOD LOSS. LATER IN THE CASE, ANOTHER SCRUB NOTICED AND POINTED OUT THE STAPLES FROM THE FIRST DEVICE WERE LAYING BY THE DEVICE ON THE BACK TABLE AND WAS NOT FIRED BY THE SCRUB. THERE WAS NO ADVERSE CONSEQUENCE TO THE PATIENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROXIMATE RELOADABLE LINEAR STAPLER GDW STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC NA F4P55P

    Patients

    Seq Age Sex Outcome Treatment
    1 CARTRIDGE