BEUDAMED
    FDA Adverse Event Injury Summary report: N

    POWERED 60 ECHELON +, 440MM SHAFT

    MDR report key: 10102754 · Received May 29, 2020

    Report

    Report Number
    3005075853-2020-02748
    Event Type
    Injury
    Date Received
    May 29, 2020
    Date of Event
    March 17, 2020
    Report Date
    May 2, 2020
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    UDI-DI
    10705036014614
    PMA / PMN Number
    K110385
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    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. WE DID NOT RECEIVE A BATCH OR LOT NUMBER FOR THE PRODUCT INVOLVED IN THIS COMPLAINT. THEREFORE, WE WERE UNABLE TO CHECK MANUFACTURING RECORDS FOR ANY RELATED NON-CONFORMANCE. ADDITIONAL INFORMATION WAS REQUESTED, AND THE FOLLOWING WAS OBTAINED: WHAT COLOR CARTRIDGES WERE USED AND ANATOMICAL STRUCTURE FOR EACH FIRING? WAS BUTTRESSING MATERIAL USED? DOES THE SURGEON ROUTINELY WAIT 15 SECONDS PRIOR TO FIRING? WAS THE BLEEDING AT THE G-J OR J-J ANASTOMOSIS? WAS THE BLEEDING INTRALUMINAL OR INTRA-ABDOMINAL? HOW WAS THE BLEEDING IDENTIFIED AND ADDRESSED? WHAT WAS THE APPROXIMATE BLOOD LOSS? WAS A TRANSFUSION REQUIRED? WERE THERE ANY DIFFICULTIES WITH DEVICE INTRAOPERATIVELY? WERE ANY STAPLE FORMATION ISSUES NOTED THROUGHOUT CARE OF PATIENT? WHAT WAS THE ADDITIONAL PROCEDURE PERFORMED? WHAT IS THE CURRENT PATIENT STATUS? ACTIVE ARTERIAL BLEEDING ON THE JEJUNAL STAPLING AREA + 1 CLIP 5MM, WASHING, DRAINAGE INTERVENTION FOR HYPOTENSION, TACHYCARDIA AND PAIN, AFTER REINTERVENTION FAVORABLE EVOLUTION. IT WAS 24 HOURS POSTOPERATIVE THAT THERE WAS AN ACTIVE BLEEDING (WITH HAEMOPERITONEUM AND HYPOTENSION) ON A JEJUNAL STAPLING (STAPLING BETWEEN THE GASTRO-JEJUNAL ANASTOMOSIS AND THE JEJUNO-JEJUNAL ANASTOMOSIS IN A GASTRIC BYPASS).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS A POST-OPERATIVE BLEEDING OF THE STAPLE LINE (JEJUNUM) 24H AFTER THE BYPASS PROCEDURE (CONVERSION NISSEN TO BYPASS). ADDITIONAL INTERVENTION/ PROCEDURE WAS NEEDED AND ADDITIONAL HOSPITALIZATION OF THE PATIENT WAS REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    563553 POWERED 60 ECHELON +, 440MM SHAFT STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. PLEE60A 10705036014614

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention