BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ETS LINEAR CUTTER

    MDR report key: 3905060 · Received July 1, 2014

    Report

    Report Number
    3005075853-2014-04531
    Event Type
    Malfunction
    Date Received
    July 1, 2014
    Date of Event
    June 6, 2014
    Report Date
    June 6, 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
    OK, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION: THE ANALYSIS SHOWED THAT THE ATW35 DEVICE WAS RECEIVED IN GOOD VISUAL CONDITION AND WITH A TR35W CARTRIDGE NOT LOADED IN THE DEVICE. THE RELOAD WAS RECEIVED PARTIALLY FIRED 1/10 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 CARTRIDGE WAS LOADED INTO THE DEVICE WITHOUT DIFFICULTIES DURING THE VISUAL AND FUNCTIONAL TESTING. 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. THE BATCH RECORD WAS REVIEWED AND NO ANOMALIES WERE NOTED DURING THE MANUFACTURING PROCESS.

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME. ADDITIONAL INFORMATION WAS REQUESTED AND THE FOLLOWING WAS OBTAINED: JUST TO CONFIRM, DID THE TR35W RELOAD COME OUT OF THE ATW35 AND GO ACROSS THE ROOM? ON WHICH FIRING(S) DID THIS EVENT OCCUR (1ST, 2ND, 12TH, ETC.)? YES. IT WAS FIRST FIRING SO IT WAS PRE-LOADED. THEY COULDN'T GET IT TO FIRE ON THE TISSUE ONCE THEY CLOSED THE DEVICE SO THEY TOOK DEVICE OUT OF PATIENT AND FIRED ON MAYO STAND BAD IT FLEW ACROSS THE ROOM. MAYBE WHEN TECH TOOK RETAINING CAP OFF IT MOVED THE STAPLE OFF TRACK?

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A ROBOTIC NEPHRECTOMY PROCEDURE, THE SURGEON WAS PERFORMING THE PROCEDURE. THE RESIDENT WENT TO FIRE THE STAPLER AND IT WOULDN'T FIRE. TOOK STAPLER OUT OF THE PATIENT AND FIRED IT ON THE MAYO STAND. THE STAPLE CAME OUT THE END OF THE STAPLER AND ACROSS THE ROOM. THERE WERE NO PATIENT CONSEQUENCES. CASE COMPLETED WITH ANOTHER DEVICE AND RELOAD OF THE SAME PRODUCT CODE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    384884 ETS LINEAR CUTTER STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 RELOAD - TR35W