BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOPATH** ILS ENDOSCOPIC CURVED INTRALUMINAL STAPLER - 29 MM

    MDR report key: 1873496 · Received October 19, 2010

    Report

    Report Number
    3005075853-2010-05927
    Event Type
    Malfunction
    Date Received
    October 19, 2010
    Date of Event
    September 23, 2010
    Report Date
    September 24, 2010
    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
    SW
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE ANALYSIS RESULTS FOUND THAT THE DEVICE ARRIVED IN GOOD VISUAL CONDITION. THE BREAKAWAY WASHER WAS PRESENT AND CUT AND THERE WERE NO STAPLES PRESENT, INDICATING THAT THE DEVICE ACHIEVED A FULL FIRING STROKE. 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. 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; THIS WOULD PREVENT THE ANVIL LOCKING ONTO 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 AN UNKNOWN PROCEDURE, THE ANVIL DID NOT FIX. IT CAME OFF WHEN THEY TRIED TO CLOSE THE ANVIL. IT IS UNKNOWN HOW THE PROCEDURE WAS COMPLETED. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOPATH** ILS ENDOSCOPIC CURVED INTRALUMINAL STAPLER - 29 MM CIRCULAR STAPLERS KOG ETHICON ENDO-SURGERY, LLC. NA F4PP5X

    Patients

    Seq Age Sex Outcome Treatment
    1