BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PWRD 31MM CURVED CIRCULAR, 18CM SHAFT

    MDR report key: 9987880 · Received April 22, 2020

    Report

    Report Number
    3005075853-2020-02289
    Event Type
    Injury
    Date Received
    April 22, 2020
    Date of Event
    April 7, 2020
    Report Date
    April 8, 2020
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    UDI-DI
    10705036015390
    PMA / PMN Number
    K163523
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). BATCH # UNK. THE LOT/BATCH WAS NOT PROVIDED; THEREFORE, THE MANUFACTURING RECORDS EVALUATION COULD NOT BE PERFORMED. ADDITIONAL INFORMATION RECEIVED: THE SURGEON HAD AN LAR CASE TUESDAY, (B)(6) 2020 IN THE AFTERNOON AT 4 PM PATIENT HAD AN ANASTOMOTIC LEAK AFTER FIRING THE CDH31P STAPLER. HE HAD TO SUTURE THE LEFT ANTERIOR LATERAL PORTION OF THE ANASTOMOSIS TO REPAIR THE LEAK. HE SUTURED SUPPOSEDLY FROM 9-1. THIS PATIENT HAD TO HAVE AN ILIOSTOMY BECAUSE OF THIS DIFFICULTY. IN ADDITION, THIS FEMALE PATIENT HAD A HYSTERECTOMY PROCEDURE AT ANOTHER HOSPITAL 4 YEARS AGO IF I UNDERSTOOD THE SURGEON CORRECTLY. SHE HAD POST OP COMPLICATIONS THAT BROUGHT HER TO DR. K - NICKED URETER, DAMAGE TO HER SIGMOID COLON THAT TURNED INTO DR. K GIVING HER A COLOSTOMY. FAST FORWARD 4 YEARS, SHE HAD A COLORECTAL STRICTURE IN HER DISTAL COLON OF SOME SORT THAT BROUGHT HER BACK TO DR. K TO DO A COLOSTOMY TAKE DOWN, RESECTION OF THE STRICTURE AND A LAR. HE HAD EVERY INTENTION TO PUT HER BACK TOGETHER WITH NO MORE COLOSTOMY AND THEN THE CDH31P HAD INCOMPLETE STAPLE LINES THAT POSED A LEAK. THEREFORE, HE REPAIRED THE LEAK AND HAD TO GIVE HER A ILIOSTOMY. PER THE ORMM CIRCULATOR THEY DID NOT SAVE THE CDH31P NOR DID THEY HAVE THE LOT #. I HAVE BEEN VERY RESPONSIVE TO THIS SITUATION AND HAVE SPOKE TO THE SURGEON THE MORNING AFTER THIS INCIDENT. ATTEMPTS ARE BEING MADE TO GET MORE DETAILS ABOUT THE CASE SPECIFICALLY THE STAPLE LINE ¿ (COMPLETE OR NOT COMPLETE, STAPLES B-FORMED OR NOT, ETC¿). HAVE YOU BEEN IN SURGERY WITH THIS CUSTOMER SINCE THIS REPORT TO BETTER UNDERSTAND THIS ISSUE? (Y/N) NO. SURGEON EXPERIENCE WITH THE DEVICE? 5 + YEARS. ADDITIONAL INFORMATION RECEIVED: THE SURGEON REVIEWED WHAT WAS ORIGINALLY REPORTED AND ADDED THAT THE PROXIMAL BOWEL WAS EXTREMELY DISTENDED. THE UNDERLYING DISEASE RELATED TO THE HYSTERECTOMY WAS FIBROIDS. THE SURGEON USUALLY USES A SIZE 29 BUT HE CHOSE A 31 BECAUSE THE DISTAL RECTUM ACCOMMODATED WITHOUT ISSUE. THERE WAS NO ISSUE WITH FIRING. THE SURGEON STATED THAT HE DOES NOT REMEMBER ABOUT THE STAPLES, IF HE SAW THEM OR THEIR SHAPE BUT THE REST SEEMED TO BE PROPERLY FORMED AND DOING THEIR JOB. THE PA HAD NO RESISTANCE WITH RELEASING THE DEVICE. TO REMOVE, 2 FULL 360- DEGREE COUNTER-CLOCKWISE ROTATIONS WERE DONE, AND THE DEVICE WAS FISHTAILED OUT. IT WAS SHARED THAT THE DEVICE WAS DISCARDED AND UNFORTUNATELY, WE WOULD NOT BE ABLE TO PERFORM AN EVALUATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAR TO RE-ANASTOMOSE A COLOSTOMY, THE SURGEON HAD AN ANTERIOR, LATERAL LEAK FROM APPROXIMATELY 9:00 TO 1:00. THE SURGEON HAND SEWED THE ANASTOMOSIS. THE PATIENT HAD TO HAVE AN ILIOSTOMY. PROCEDURE WAS DELAYED ONE HOUR DUE TO THE REPORTED EVENT. THIS PATIENT HAD A COLOSTOMY, HAD A STRICTURE AND THEY WENT IN TO FIX STRICTURE AND RECONNECT HER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    448797 PWRD 31MM CURVED CIRCULAR, 18CM SHAFT STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. CDH31P 10705036015390

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention