BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PWRD 29MM CURVED CIRCULAR, 18CM SHAFT

    MDR report key: 8784750 · Received July 12, 2019

    Report

    Report Number
    3005075853-2019-20353
    Event Type
    Injury
    Date Received
    July 12, 2019
    Date of Event
    June 21, 2019
    Report Date
    June 21, 2019
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    UDI-DI
    10705036015383
    PMA / PMN Number
    K163523
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT #: (B)(4). BATCH # UNK. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER, AND NO NON-CONFORMANCES WERE IDENTIFIED. ADDITIONAL INFORMATION WAS REQUESTED AND THE FOLLOWING WAS OBTAINED: WHAT WERE THE INDICATIONS FOR SURGERY? LEFT COLON CANCER. WERE THERE ANY ISSUES IN REGARDS TO DEVICE PERFORMANCE AT ALL DURING THE SURGICAL PROCEDURE? NO. WHAT HEALTHCARE PROFESSIONAL FIRED THE DEVICE AND WHAT IS HIS/HER EXPERIENCE WITH THE DEVICE? DR (B)(6), SURGEON DIRECTOR. WHERE IN THE GREEN GAP SETTING SCALE WAS THE INDICATOR LOCATED PRIOR TO FIRING (LOW-B, MIDDLE-B, OR HIGH-B)? MIDDLE. DID THE HEALTHCARE PROFESSIONAL WAIT 15 SECONDS AFTER CLOSING THE DEVICE AND THEN RETIGHTEN PRIOR TO FIRING? YES. WERE THERE ANY ISSUES WITH DEVICE USE/FIRING? NO. WAS THE GREEN CHECKMARK VISIBLE AT THE END OF THE FIRING? YES. WAS THERE ANY DIFFICULTY REMOVING THE DEVICE? NO. WAS A COMPLETE TRANSECTION OF THE WHITE BREAKAWAY WASHER VISUALLY CONFIRMED? YES. WERE THE DONUTS INSPECTED? IF SO, PLEASE DESCRIBE. WELL DONE. WAS A LEAK TEST PERFORMED? IF SO, WHAT WAS THE RESULT? BUBBLE TEST WITH AIR WAS OK. DID THE PATIENT EXPERIENCE A POSTOPERATIVE LEAK OR BLEEDING OR BOTH? BOOTH. HOW WERE THE POSTOPERATIVE ISSUES IDENTIFIED? DRAINAGE. CAN MORE INFORMATION BE PROVIDED ON WHAT WAS MEANT BY ¿FAILURE OF THE ANASTOMOSIS AND CLIPS WERE ALL ON THE SIDE OF THE COLON¿? WHEN THEY ONE THEY FIND 30% OF GRAFS (STAPLES) ON THE PELVIC FLOOR. WERE ANY STAPLE FORMATION ISSUES IDENTIFIED? IF SO, PLEASE DESCRIBE THE SHAPE AND SPECIFIC LOCATION. THEY WERE CLOSED. WHAT WAS DONE DURING THE REOPERATION? STOMIA. WAS ANY OTHER TREATMENT REQUIRED? WHAT IS THE CURRENT STATUS OF THE PATIENT? STILL IN HOSPITAL. WOULD THE SURGEON BE INTERESTED IN SPEAKING WITH ETHICON MEDICAL AND ENGINEERING PERSONNEL? HE SPOKE WITH OUR MEDICAL DIRECTOR. INFORMATION RECEIVED FROM LOCAL MEDICAL AFFAIRS: ACCORDING TO DR. (B)(6) HE AND HIS TEAM HAVE PERFORMED ABOUT 250 CONSECUTIVE ANASTOMOSES ALL FOLLOWING THE SAME SOP. IN ALL THOSE CASES THEY HAVE NOT OBSERVED A SINGLE (ZERO) ANASTOMOTIC LEAK. THE CASE DISCUSSED WAS LAPAROSCOPIC LAR (LOWER ANTERIOR RESECTIONS) FOR COLON CANCER. THE CASE FOLLOWED A STRICT INTERNAL SOP (E.G. ERAS PROTOCOL IN PLACE / CENTRAL LIGATURE OF SUPPLYING ARTERY / DOPPLER-ULTRASOUND BEFORE AND AFTER THE ANASTOMOSIS TO DOCUMENT ARTERIAL BLOOD SUPPLY / ANASTOMOSES PERFORMED AS TERMINO-LATERAL ANASTOMOSES / BUBBLE-TEST AND ENDOSCOPY FOR LEAKAGE IDENTIFICATION / EARLY MOBILIZATION / FOOD 2ND DAY) THE PATIENT PRESENTED INCREASING SIGNS OF INFECTION ON DAY 8 AND WAS BROUGHT BACK TO OR AFTER RADIOLOGICAL SIGNS OF ANASTOMOTIC LEAKAGE. INTRAOP 70% OF CIRCUMFERENCE OF ANASTOMOSIS WAS WIDE OPEN. B-FORMED STAPLES WERE FOUND IN CAVITY AND APPEARED TO BE FULLY FORMED STAPLES. PATIENT UNDERWENT HARTMANN-PROCEDURE AND IS RECOVERING WELL.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT FOLLOWING A LAPAROSCOPIC LEFT HEMICOLECTOMY WITH LATERO / TERMINAL ANASTOMOSIS PROCEDURE ON (B)(6) 2019, THERE WAS ANASTOMOTIC LEAKAGE AND BLEEDING AFTER NINE DAYS. PATIENT HAD TO BE RE-OPERATED. INTRAOPERATIVE DOPPLER CONTROL WAS USED TO VERIFY PERFUSION AND ENDOSCOPIC CONTROL TO VERIFY ANASTOMOSIS FORMATION. THE ANASTOMOSIS WAS OPTIMAL. THE OPERATOR HAD PROCEEDED SLOWLY APPROACHING THE TISSUE, HAD WAITED MORE THAN 15 SECONDS BEFORE FIRING AND CAME OUT VASCULATING AFTER OPENING 2 WHOLE LAPS. ON (B)(6) 2019, THE PATIENT WAS REOPERATED DUE TO FAILURE OF THE ANASTOMOSIS; CLIPS WERE ALL ON THE SIDE OF THE COLON. THE PATIENT IS STILL HOSPITALIZED FOLLOWING REOPERATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    578960 PWRD 29MM CURVED CIRCULAR, 18CM SHAFT STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. T92J8X 10705036015383

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R