BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PWRD 29MM CURVED CIRCULAR, 18CM SHAFT

    MDR report key: 11615831 · Received April 5, 2021

    Report

    Report Number
    3005075853-2021-01768
    Event Type
    Malfunction
    Date Received
    April 5, 2021
    Date of Event
    March 10, 2021
    Report Date
    March 11, 2021
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    UDI-DI
    10705036015383
    PMA / PMN Number
    K163523
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). DATE SENT: 05/03/2021. D4: BATCH # U5CF6M. H6: COMPONENT CODE = OTHERS (G07). DEVICE ANALYSIS: THE PRODUCT WAS RETURNED FOR EVALUATION. VISUAL INSPECTION AND FUNCTIONAL TESTING WERE CONDUCTED ON THE RETURNED DEVICE. VISUAL ANALYSIS OF THE RETURNED SAMPLE REVEALED THAT THE CDH29P DEVICE ARRIVED WITH NO APPARENT DAMAGE. THE DEVICE WILL NOT FIRE IF THE ANVIL IS NOT PROPERLY ATTACHED OR IF THE ORANGE STAPLE HEIGHT INDICATOR IS NOT FULLY WITHIN THE GREEN RANGE OF THE TISSUE COMPRESSION SCALE. TO FIRE THE DEVICE, DRAW THE RED SAFETY BACK TOWARD THE HANDLE. TO ENSURE THE DEVICE REMAINS IN THE SAFE FIRING RANGE, ONCE THE RED SAFETY HAS BEEN RELEASED, DO NOT TURN THE ADJUSTING KNOB. ACTIVATE THE FIRING SEQUENCE BY COMPLETELY DEPRESSING THE FIRING TRIGGER. REMAIN STILL UNTIL THE FULL FIRING SEQUENCE IS COMPLETED WHICH WILL BE INDICATED BY THE ILLUMINATED GREEN CHECK MARK ON THE INDICATOR WINDOW. IT IS NOT NECESSARY TO HOLD THE TRIGGER ONCE THE FIRING SEQUENCE HAS INITIATED. THE USER MAY NOTICE AUDIBLE FEEDBACK DURING THE FIRING SEQUENCE WHEN CUTTING THROUGH THE BREAKAWAY WASHER. ONCE FIRED, THE DEVICE CANNOT BE FIRED AGAIN. AS PART OF ETHICON ENDO SURGERY¿S QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. ALTHOUGH NO CONCLUSION COULD BE REACHED ON THE CAUSE OF THE REPORTED EVENT, THE INSTRUCTIONS FOR USE DO CONTAIN THE FOLLOWING CAUTION: THE DEVICE WILL NOT FIRE IF THE ANVIL IS NOT PROPERLY ATTACHED OR IF THE ORANGE STAPLE HEIGHT INDICATOR IS NOT FULLY WITHIN THE GREEN RANGE OF THE TISSUE COMPRESSION SCALE. TO FIRE THE DEVICE, DRAW THE RED SAFETY BACK TOWARD THE HANDLE. TO ENSURE THE DEVICE REMAINS IN THE SAFE FIRING RANGE, ONCE THE RED SAFETY HAS BEEN RELEASED, DO NOT TURN THE ADJUSTING KNOB. ACTIVATE THE FIRING SEQUENCE BY COMPLETELY DEPRESSING THE FIRING TRIGGER. REMAIN STILL UNTIL THE FULL FIRING SEQUENCE IS COMPLETED WHICH WILL BE INDICATED BY THE ILLUMINATED GREEN CHECK MARK ON THE INDICATOR WINDOW. IT IS NOT NECESSARY TO HOLD THE TRIGGER ONCE THE FIRING SEQUENCE HAS INITIATED. THE USER MAY NOTICE AUDIBLE FEEDBACK DURING THE FIRING SEQUENCE WHEN CUTTING THROUGH THE BREAKAWAY WASHER. ONCE FIRED, THE DEVICE CANNOT BE FIRED AGAIN. THE EVENT DESCRIBED COULD NOT BE CONFIRMED AS THE DEVICE PERFORMED WITHOUT ANY DIFFICULTIES NOTED. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE BATCH NUMBER, AND NO NON-CONFORMANCES WERE IDENTIFIED.

    Additional Manufacturer Narrative · 1

    (B)(4). BATCH #: UNKNOWN. THE LOT/BATCH WAS NOT PROVIDED; THEREFORE, THE MANUFACTURING RECORD EVALUATION COULD NOT BE PERFORMED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A ROBOTIC COLOSTOMY TAKEDOWN, EXTREMELY CHALLENGING CASE, PATIENT, ANATOMY, TISSUE WAS THICK AND FIBROTIC. ROBOTIC STAPLER STRUGGLED WITH PROXIMAL COLON TRANSECTIONS, BOTH WITH GREEN AND BLACK RELOADS. THE SURGEON RE-CLAMPED ABOUT 1 DOZEN TIMES ON 2 PROXIMAL TRANSECTIONS. THE ROBOTIC STAPLER COMPRESSION TOOK LONGER THAN USUAL AND PAUSED TO RECALIBRATE AT MULTIPLE POINTS. WHEN THE TIME CAME TO INSERT POWERED CIRCULAR, DR. X STRUGGLED TO INSERT THE STAPLER THE FULL DISTANCE IN THE RECTUM. DR. X CALLED IN DR. K FOR SUPPORT. STAPLER WAS REMOVED AND DR. X RETURNED TO CONSOLE TO EXPLORE ISSUE. HE ULTIMATELY TRANSECTED THE BLOCKAGE, SO THAT THEY COULD ACCESS THE POINT WHERE THE CIRCULAR STAPLER COULD REACH. ON 2ND ATTEMPT, DR. K INSERTED STAPLER, AND PROCEEDED TO EXTEND CIRCULAR TROCAR AND CONNECT TO ANVIL. SURGEON WAS ABOUT HALFWAY DOWN THE GREEN ZONE OF THE COMPRESSION SCALE, WAITED 15 SECONDS, AND PROCEEDED TO REMOVE SAFETY AND FIRE. HOWEVER, NOTHING HAPPENED. THE CHECKMARK WAS BRIGHT GREEN. HE SAID THE CHECKMARK WAS ALREADY BRIGHT GREEN EVEN BEFORE HE ATTEMPTED TO FIRE. SO, LIGHT WAS ON THUS BATTERY APPEARED TO HAVE POWER, BUT THE DEVICE DID NOT FIRE. ATTEMPTED TRIGGER 2 TIMES. DR. K PROCEEDED TO RELEASE STAPLER TO CONFIRM, NO STAPLES DEPLOYED. THEN, WE REMOVED STAPLER FROM PATIENT, AND USED A 2ND DEVICE TO FIRE. DR. K WAITING LONGER THAN 15 SECONDS, THEN FIRED THE NEW DEVICE, AND ALL WORKED APPROPRIATELY. 2 PERFECT DONUTS AND 0 BUBBLES UPON LEAK TEST. THE ANVIL WILL SHOW A BROKEN WASHER, BECAUSE IT WAS USED WITH THE 2ND DEVICE. THE CASE STARTED AT 2PM AND ENDED AFTER 7PM BECAUSE OF MULTIPLE ISSUES. THE SWITCH OUT OF CIRCULAR STAPLERS ONLY DELAYED ABOUT 5 MINUTES. THERE WERE NO PATIENT CONSEQUENCES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    511523 PWRD 29MM CURVED CIRCULAR, 18CM SHAFT STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. CDH29P 10705036015383

    Patients

    Seq Age Sex Outcome Treatment
    1