BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PWRD 29MM CURVED CIRCULAR, 18CM SHAFT

    MDR report key: 10123130 · Received June 5, 2020

    Report

    Report Number
    3005075853-2020-02870
    Event Type
    Injury
    Date Received
    June 5, 2020
    Date of Event
    May 11, 2020
    Report Date
    May 14, 2020
    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 · 0

    (B)(4). DATE SENT: 06/17/2020. ADDITIONAL INFORMATION WAS REQUESTED, AND FOLLOWING WAS RECEIVED: 1.WAS THE LEAK FOUND AND RESOLVED IN THE INITIAL SURGERY (NO RE-OPERATION REQUIRED)? OR, WAS THE LEAK FOUND AFTER THE INITIAL SURGERY WAS COMPLETED AND A RE-OPERATION WAS REQUIRED)? THE FOUND THE LEAK IN THE INITIAL SURGERY. PER PHOTOGRAPHIC EVALUATION: UPON VISUAL INSPECTION OF ONE PHOTO, THE FOLLOWING WAS OBSERVED: THE PHOTO SHOWS TISSUE AND BLEEDING COULD BE OBSERVED ON THE TISSUE. IN ADDITION, NO MALFORMED STAPLES WERE OBSERVED. BASED ON THE PHOTO NO CONCLUSION COULD BE REACHED AS TO WHAT MAY HAVE CAUSED THE REPORTED INCIDENT, THE ASSIGNABLE CAUSE OF THE REPORTED COMPLAINT COULD NOT BE DETERMINED. HANDS ON DEVICE ANALYSIS MAY PROVIDE THE ADDITIONAL EVIDENCE NECESSARY TO CONFIRM THE ROOT CAUSE OF THE REPORTED EVENT. NO DEVICE HAS BEEN RECEIVED TO DATE.

    Additional Manufacturer Narrative · 1

    (B)(4). BATCH # UNK. ATTEMPTS HAVE BEEN MADE TO RETRIEVE THE DEVICE. TO DATE THE DEVICE HAS NOT BEEN RETURNED. IF THE DEVICE OR FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. THE LOT/BATCH WAS NOT PROVIDED; THEREFORE, THE MANUFACTURING RECORD EVALUATION COULD NOT BE PERFORMED. ADDITIONAL INFORMATION WAS REQUESTED, AND THE FOLLOWING WAS RECEIVED: WHAT IS THE PRODUCT CODE FOR THE DEVICE THAT WAS USED IN THE SURGERY? CDH29P. WHAT WERE THE INDICATIONS FOR SURGERY? THEY PERFORMED AN ANASTOMOSES. WHAT SURGICAL PROCEDURE WAS PERFORMED? LAR. DID THE PATIENT RECEIVE ANY PREOPERATIVE CHEMOTHERAPY OR RADIATION? YES. HOW MANY DAYS POST-OP WAS THE LEAK IDENTIFIED? DURING SURGERY ¿ RIGHT AWAY. WHAT WERE THE FORMATION OF THE LOOSE STAPLES THAT WERE IDENTIFIED AT THE ANASTOMOSIS? THEY SAW AT LEAST 3 LOOSE STAPLES. WERE THERE STAPLES MISSING FROM THE ANASTOMOSIS? DO NOT KNOW. WERE THERE DIFFICULTIES IN MOBILIZATION OF THE COLON OR RECTUM? NO. WAS A LEAK TEST PERFORMED? IF SO, WHAT TYPE AND WHAT WAS THE RESULT? IT WAS NOT NECESSARY AS THEY SAW THE LEAK BOBBLES RIGHT AWAY. WAS THE STAPLE LINE VISUALIZED ENDOSCOPICALLY DURING THE INITIAL SURGICAL PROCEDURE? YES. HOW MANY DAYS POSTOPERATIVE DID THE LEAK OCCUR? DURING SURGERY ¿ RIGHT AWAY. HOW WAS THE LEAK IDENTIFIED? BUBBLES AT AFTER STAPLING. WHAT WAS OBSERVED AT THE SITE OF THE LEAK UPON REOPERATION? NO ANSWER. HOW WAS THE LEAK ADDRESSED? THEY PERFORMED A NEW ANASTOMOSE WITH AT NEW CDH29P. WHAT IS THE CURRENT STATUS OF THE PATIENT? HI IS DOING OK. IF A CIRCULAR DEVICE WAS USED, PLEASE ANSWER THE FOLLOWING QUESTIONS: WERE THERE ANY ISSUES EXPERIENCED WITH THE DEVICE IN THE INITIAL SURGICAL PROCEDURE? NO. WHAT HEALTHCARE PROFESSIONAL FIRED THE DEVICE AND WHAT IS HIS/HER EXPERIENCE WITH THE DEVICE? A VERY SKILLED SURGEON. WHERE IN THE GREEN GAP SETTING SCALE WAS THE INDICATOR LOCATED PRIOR TO FIRING (LOW-B, MIDDLE-B, OR HIGH-B)? HE DO NOT RECALL. DID THE HEALTHCARE PROFESSIONAL WAIT 15 SECONDS AFTER CLOSING THE DEVICE AND THEN RETIGHTEN PRIOR TO FIRING? YES. WAS THE DEVICE DIFFICULT TO CLOSE? NO. WAS THE DEVICE DIFFICULT TO FIRE? NO. DID THE HEALTHCARE PROFESSIONAL RECEIVE AUDIBLE & TACTILE FEEDBACK WHEN FIRING THE DEVICE? YES. WERE THE DONUTS INSPECTED? IF SO, PLEASE DESCRIBE. THEY WERE FINE. WAS A COMPLETE TRANSECTION OF THE WHITE BREAKAWAY WASHER VISUALLY CONFIRMED? YES WERE THERE ANY ISSUES NOTED WITH STAPLE FORMATION AT ANY POINT THROUGHOUT THE CARE OF THE PATIENT? IF SO, PLEASE DESCRIBE THE SHAPE AND LOCATION. NO ANSWER. CLARIFICATION IS NEEDED. IT WAS REPORTED THAT THE LEAK OCCURRED DAYS LATER. BASED ON FOLLOW-UP RECEIVED THE LEAK WAS IDENTIFIED RIGHT AWAY. WAS THE LEAK FOUND AND RESOLVED IN THE INITIAL SURGERY (NO RE-OPERATION REQUIRED)? OR, WAS THE LEAK FOUND AFTER THE INITIAL SURGERY WAS COMPLETED AND A RE-OPERATION WAS REQUIRED)?

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC ANTERIOR RESECTION, AS THEY WERE DOING A COLON-RECTAL ANASTOMOSES THE STAPLER WOULD NOT LET GO BEFORE AFTER SERVAL CENTIMETERS OF WITHDRAWAL FROM THE ANASTOMOSES (THE DID THE 2 ENTIRE OPENING AS THEY ARE SUPPOSED TO DO AND THEY ARE VERY USED TO USE OUR STAPLER). THIS GAVE A TREMENDOUS MOVEMENT IN THE INTESTINE WHICH RESULTED IN A BIG DEFECT ON THE BACK OF THE ANASTOMOSE WHICH RESULTED IN THE FACT THAT THEY HAD TO DO A NEW ANASTOMOSE WITH A NEW STAPLER. THEY DISCOVERED THAT THERE WERE SERVAL LOOSE CLIPS AT THE ANASTOMOSE AS THEY ARE VERY SURE ABOUT THE FACT THAT THIS STAPLER WAS DEFECT. (THERE WAS NO STRETCHING ON THE ANASTOMOSE). THE PATIENT HAD A LEAKAGE TO DAYS LATER AND HAD TO GET OPERATED AGAIN. THE PATIENT DOING GOOD NOW AFTER THE SECOND SURGERY. THE PATIENT HAS BEEN UNDERGOING CHEMOTHERAPY, LEVER RESECTION DUE TO METASTASES AND ADDITIONALLY TO THIS, THE PATIENT HAS HAD COLITIS ULCEROUS FOR MANY YEARS ¿ SO THIS PATIENT IS A HIGH-RISK PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    586621 PWRD 29MM CURVED CIRCULAR, 18CM SHAFT STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. CDH29P 10705036015383

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention