BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ETS-FLEX - ENDOSCOPIC

    MDR report key: 2872495 · Received December 13, 2012

    Report

    Report Number
    3005075853-2012-05681
    Event Type
    Malfunction
    Date Received
    December 13, 2012
    Date of Event
    November 28, 2012
    Report Date
    November 28, 2012
    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
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). A SURGICAL PHOTOGRAPH WAS RECEIVED AND REVIEWED. THE TYPE OF STAPLE FORMS SEEN IN THE SUBJECT PHOTOGRAPH ARE REPRESENTATIVE OF THOSE EXPECTED TO SEE IF THERE WAS A CONSIDERABLE ALIGNMENT MISMATCH BETWEEN THE STAPLE POCKETS AND THE ANVIL POCKETS. THIS TYPE OF ALIGNMENT ISSUE CAN BE CAUSED WHEN THE STAPLE CARTRIDGE IS NOT PLACED AND SEATED PROPERLY IN THE CARTRIDGE CHANNEL. THE STAPLE CARTRIDGE WOULD BE NOT POSITION ALL THE WAY BACK INTO THE DEVICE JAWS. THIS IS REFERRED TO AS A LONG LOAD, WHERE THE TAB ON THE STAPLE CARTRIDGE IS IN FRONT OF THE CHANNEL AND NOT SNAPPED INTO THE SLOT ON THE CHANNEL. BASED ON THE EVENT DESCRIPTION AND THE PHOTOGRAPHIC EVIDENCE, IT IS BELIEVED THAT THE DEVICE COMPLICATION WAS THE RESULT OF THE CARTRIDGE BEING IMPROPERLY PLACED AND SEATED IN THE CARTRIDGE CHANNEL, CREATING A STAPLE POCKET TO ANVIL POCKET ALIGNMENT ISSUE.

    Additional Manufacturer Narrative · 1

    (B)(4). DAMAGED CARTRIDGE AND DAMAGED CARTRIDGE LOCKOUT TAB. THE ANALYSIS SHOWED THAT THE DEVICE WAS RECEIVED IN GOOD VISUAL CONDITION AND WITH A RELOAD LOADED IN THE DEVICE. THE RELOAD WAS RECEIVED PARTIALLY FIRED 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. IN ADDITION, THE CARTRIDGE PAN WAS DISENGAGED FROM THE DISTAL PART AS THE DISTAL HEAT STAKE WAS BROKEN. 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 NOTE TO HAVE THE PROPER B-FORMED SHAPE. WHILE NO CONCLUSION COULD BE REACHED AS TO HOW THE DAMAGE TO THE CARTRIDGE OCCURRED, IT SHOULD BE NOTED THAT AS PART OF OUR QUALITY PROCESS, EACH DEVICE IS VISUALLY INSPECTED AND FUNCTIONALLY TESTED DURING MANUFACTURING TO ENSURE THAT THE DEVICE MEETS THE REQUIRED SPECIFICATIONS PRIOR TO SHIPMENT. THE BATCH RECORD WAS REVIEWED AND NO ANOMALIES WERE NOTED DURING THE MANUFACTURING PROCESS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN AUTO NEPHRECTOMY PROCEDURE, ON THE FIRST FIRING WITH A WHITE RELOAD ON THE RENAL ARTERY, THE CLIPS DID NOT FORM THE B-SHAPE, THEY WERE MALFORMED. THERE WERE NO STAPLE LINES OR CLIPS IN THE AREA. IT WAS NOTED THAT THE RELOAD DID NOT SEEM TO FIT PROPERLY AND THEY DID NOT HEAR THE CLICK SOUND AS IT WAS PUT INTO PLACE. THERE WAS A TEN MINUTE DELAY TO THE PROCEDURE WHILE THEY MANAGED THE SITUATION. APPROXIMATELY 10 ML OF BLOOD LOSS. THERE WAS NO INJURY TO THE PATIENT AND THE PATIENT DID WELL. PROCEDURE COMPLETED WITH SAME/LIKE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ETS-FLEX - ENDOSCOPIC STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1