BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ETS LINEAR CUTTER

    MDR report key: 4232201 · Received November 6, 2014

    Report

    Report Number
    3005075853-2014-07677
    Event Type
    Malfunction
    Date Received
    November 6, 2014
    Date of Event
    October 21, 2014
    Report Date
    October 21, 2014
    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
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION: THE ANALYSIS SHOWED THAT THE ATS45 DEVICE WAS RECEIVED IN GOOD VISUAL CONDITION AND WITH A TR45W CARTRIDGE LOADED IN THE DEVICE. THE RELOAD WAS RECEIVED PARTIALLY FIRED 1/8 AND WITH THE RELOAD LOCK OUT SPRING DAMAGED. THE DAMAGE TO THE RELOAD LOCKOUT SPRING IS CONSISTENT WITH DAMAGE OBSERVED WHEN THE FIRING CYCLE IS STARTED, INTERRUPTED, RELEASED, AND RESTARTED. WHEN FIRING THE DEVICE MAKE SURE THAT THE FIRING STROKE IS COMPLETED. DO NOT PARTIALLY FIRE THE DEVICE. FIRE THE DEVICE BY SQUEEZING THE FIRING TRIGGER COMPLETELY UNTIL IT RESTS ON THE CLOSING TRIGGER. ONCE THE FIRING CYCLE HAS BEEN INITIATED, IT MUST BE COMPLETED. IF RE-INITIATION OF FIRING IS RESUMED, THE DEVICE WILL LOCKOUT. FIRING THROUGH THE LOCKOUT MECHANISM WILL BREAK THE DEVICE. PLEASE REFERENCE THE INSTRUCTION FOR USE FOR MORE INFORMATION. THE RETURNED DEVICE WAS TESTED FOR FUNCTIONALITY WITH A TEST RELOAD AND IT FIRED, CUT AND FORMED ALL THE STAPLES AS INTENDED. THE DEVICE FIRED WITHOUT ANY DIFFICULTIES, THE STAPLE LINE WAS COMPLETE AND THE STAPLES WERE NOTED TO HAVE THE PROPER B-FORMED SHAPE. NO SHORT CUT OR MALFORMED STAPLES WERE NOTED DURING FUNCTIONAL TESTING. THE BATCH RECORD WAS REVIEWED AND NO ANOMALIES WERE NOTED DURING THE MANUFACTURING PROCESS.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC APPENDECTOMY PROCEDURE, THE DOCTOR FIRED THE FIRST FIRING WITH A GREY LOAD. THE BLADE ADVANCED AND MADE A LOUD NOISE AND DIDN'T "FEEL RIGHT". HE OPENED THE JAW AND IT DID NOT APPEAR THE STAPLES FORMED CORRECTLY. THE BLADE ALSO DID NOT ADVANCE FAR ENOUGH TO CUT TISSUE. THEY DECIDED TO OPEN A SECOND GUN AND USE A WHITE LOAD. WITH THIS FIRING THE GUN LOCKED UP. THEY DECIDED TO REMOVE THE GUN OFF TISSUE AND FINISH THE CASE WITH A CLIP APPLIER. THERE WERE NO PATIENT CONSEQUENCES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    712997 ETS LINEAR CUTTER STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. NA L4F13G

    Patients

    Seq Age Sex Outcome Treatment
    1