BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOPATH** ETS45 ENDOSCOPIC LINEAR CUTTER

    MDR report key: 1881183 · Received October 25, 2010

    Report

    Report Number
    3005075853-2010-06031
    Event Type
    Malfunction
    Date Received
    October 25, 2010
    Date of Event
    September 22, 2010
    Report Date
    September 29, 2010
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K020779
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE ANALYSIS RESULTS FOUND THAT THE ETS45 DEVICE WAS RECEIVED IN GOOD VISUAL CONDITION AND WITH A RELOAD LOADED ON THE DEVICE. THE RELOAD WAS RECEIVED FULLY LOADED WITH STAPLES. THE DEVICE WAS TESTED FOR FUNCTIONALITY WITH THE RETURNED RELOAD AND IT FIRED, CUT AND FORMED THE STAPLES AS INTENDED. THE CARTRIDGE WAS TAKEN OFF OF THE DEVICE AND PLACED BACK ON AND IT CLICK INTO PLACE. THE DEVICE FIRED WITHOUT ANY DIFFICULTIES, THE STAPLE LINE WAS COMPLETE 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

    PT WAS REVISED TO ADDRESS OSTEOLYSIS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC APPENDECTOMY PROCEDURE, THEY OPENED AND CLOSED THE STAPLER TWICE TO CHECK THAT THE INSTRUMENT WORKED WELL. DURING THE FIRING THEY DIDN¿T FEEL RESISTANCE. THEY OPENED THE JAW, THE STAPLER CUT BUT DIDN'T STAPLE. THEY RE-STAPLED USING A COMPETITIVE DEVICE. THEY USED AN EXTRA 5MM TROCAR TO REACH THE PLACE BETTER. AFTER THE SURGERY THEY TOOK ANOTHER RELOAD TO TEST THE STAPLER AND THAT WENT WELL. SO THE PROBLEM IS PROBABLY THE RELOAD AND NOT THE DEVICE. THE PROCEDURE WAS PROLONGED 60 MINUTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOPATH** ETS45 ENDOSCOPIC LINEAR CUTTER STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. UNK G4TBN54

    Patients

    Seq Age Sex Outcome Treatment
    1 6R45B, LOT#- G4RA5X