BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ECHELON 60MM REINFORCEMENT

    MDR report key: 11994994 · Received June 14, 2021

    Report

    Report Number
    3005075853-2021-03293
    Event Type
    Injury
    Date Received
    June 14, 2021
    Date of Event
    May 1, 2021
    Report Date
    May 17, 2021
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    OXC
    UDI-DI
    10705036023296
    PMA / PMN Number
    K190937
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). BATCH #: UNKNOWN. AS THE DEVICE WAS NOT RETURNED, AN ANALYSIS INVESTIGATION COULD NOT BE PERFORMED. A CONCLUSION COULD NOT BE REACHED AS TO WHAT MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT. 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 RECEIVED: THE SURGEON HAS HAD 4 POST-OP LEAKS THAT REQUIRED STENTS INVOLVING 2 BYPASSES AND 2 SLEEVES. ONE BUTTRESS ONLY USED ON VERTICAL FIRING OF THE POUCH CREATION. RIGHT AROUND BEGINNING OF VERTICAL PORTION IS WHERE LEAKS OCCUR. THE SURGEONS USE ONE CONTINUOUS FIRING-NO PULSE FIRING AND ALWAYS WAITS 15 SECONDS. ANOTHER SURGEON HAD ONE COMPLICATION AND USES BLUE ALL OF THE WAY FOR SLEEVES. THIS SURGEON USES THE FOLLOWING CARTRIDGE SELECTION: BLACK, GOLD, GREEN, SOMETIMES BLUE NEAR FUNDUS. ADDITIONAL INFORMATION WAS REQUESTED, AND THE FOLLOWING WAS OBTAINED: WERE THERE ANY ISSUES EXPERIENCED WITH THE DEVICE IN THE INITIAL SURGICAL PROCEDURE? WAS A LEAK TEST PERFORMED? IF SO, WHAT TYPE AND WHAT WAS THE RESULT? HOW WAS THE LEAK IDENTIFIED? WHAT WAS OBSERVED AT THE SITE OF THE LEAK UPON REOPERATION? 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. RESPONSE RECEIVED: NO TO ALL QUESTIONS AND LEAK WAS FOUND 8 DAYS LATER

    Description of Event or Problem · 1

    IT WAS REPORTED THAT TWELVE DAYS POST OP AFTER A GASTRIC SLEEVE THE PATIENT WAS BROUGHT BACK TO THE OR FOR A LEAK. THE PATIENT WAS DRAINED AND STINTED. THERE IS NO ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    891513 ECHELON 60MM REINFORCEMENT SURGICAL MESH OXC ETHICON ENDO-SURGERY, LLC. 10705036023296

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention