BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOPATH STEALTH CIR STAPLER

    MDR report key: 2082656 · Received May 10, 2011

    Report

    Report Number
    3005075853-2011-01895
    Event Type
    Malfunction
    Date Received
    May 10, 2011
    Date of Event
    April 18, 2011
    Report Date
    April 20, 2011
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    KOG
    PMA / PMN Number
    K940967
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    (B)(4). INCOMPLETE FIRING CYCLE. THE ANALYSIS RESULTS FOUND THAT ONE WAS RECEIVED IN GOOD VISUAL CONDITION. THE BREAKAWAY WASHER WAS PRESENT AND CUT; THE DEVICE WAS RECEIVED WITH ONLY FOUR STAPLES PRESENT AND PROTRUDING, INDICATING THAT THE DEVICE HAD NOT BEEN FIRED THROUGH A FULL FIRING STROKE. WHILE NO CONCLUSION COULD BE REACHED AS TO HOW THE WASHER WAS CUT WITHOUT THE INSTRUMENT DEPLOYING ALL THE STAPLES, IT IS POSSIBLE THAT THE RETURNED ANVIL DOES NOT BELONG TO THE RETURNED DEVICE. THE DEVICE WAS RELOADED WITH STAPLES, A NEW WASHER WAS PLACED ON THE DEVICE AND IT WAS TESTED FOR FUNCTIONALITY. IT FIRED AND FORMED ALL THE STAPLES AS WELL AS COMPLETELY CUT THE TEST MEDIA AND THE BREAKAWAY WASHER WITHOUT INCIDENT. THE STAPLE LINE WAS COMPLETE AND THE STAPLES WERE NOTED TO HAVE THE PROPER B-FORMED SHAPE. THE ANVIL WAS PLACED ON THE DEVICE COMPLETELY AND WITHOUT ANY DIFFICULTIES AND DID NOT DISENGAGE DURING FUNCTIONAL TESTING. ALTHOUGH THERE IS NO CONCLUSION AS TO WHAT CAUSED THE REPORTED INCIDENT, IT IS POSSIBLE THAT THE ANVIL WAS GRIPPED BY THE LOCKING SPRINGS WHILE TRYING TO REATTACH TO THE DEVICE. IT SHOULD BE NOTED THAT WHEN ATTEMPTING TO REATTACH THE DETACHABLE HEAD OR ANVIL, DO NOT CLAMP ACROSS OR GRIP ON THE LOCKING SPRINGS AS IT MIGHT NOT CLICK INTO PLACE. WHEN THIS HAPPENS, THE ANVIL WILL NOT SIT CORRECTLY/COMPLETELY IN THE DEVICE. 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 LAPAROSCOPIC GASTRIC BYPASS PROCEDURE, THE DEVICE WAS BEING FIRED ON THE JEJUNOSTOMY AND THE DEVICE DID NOT FIRE. THE REP STATED THAT THE ANVIL POPPED OFF. THE DEVICE WAS REMOVED AND ANOTHER DEVICE WAS USED TO COMPLETE THE CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOPATH STEALTH CIR STAPLER CIRCULAR STAPLERS KOG ETHICON ENDO-SURGERY, LLC. NA G4U888

    Patients

    Seq Age Sex Outcome Treatment
    1