BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GST GREEN RELOAD, 60MM, 6 ROW

    MDR report key: 8379728 · Received February 28, 2019

    Report

    Report Number
    3005075853-2019-16945
    Event Type
    Malfunction
    Date Received
    February 28, 2019
    Date of Event
    January 1, 2019
    Report Date
    January 30, 2019
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    UDI-DI
    10705036014713
    PMA / PMN Number
    K110385
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). ADDITIONAL INFORMATION: ACTUAL DEVICE WAS NOT RETURNED, ONE PHOTO WAS PROVIDED. THE PICTURE SHOWS A GREEN RELOAD FROM THE TOP VIEW. THE RELOAD CAN BE SEEN PARTIALLY FIRED FROM THE LEFT SIDE AND FULLY FIRED FROM THE RIGHT SIDE. THE SLED APPEARS TO BE IN THE DISTAL END OF THE RELOAD. BASED ON THE PHOTO REVIEWED THE EVENT DESCRIBE IS CONFIRMED. HANDS ON DEVICE ANALYSIS MAY PROVIDE THE ADDITIONAL EVIDENCE NECESSARY TO CONFIRM THE ROOT CAUSE OF THE REPORTED EVENT.

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT #: (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 MANUFACTURING RECORD EVALUATION WAS PERFORMED, AND THE MANUFACTURING CRITERIA WAS MET PRIOR TO THE RELEASE OF THIS BATCH/LOT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC GASTRIC SLEEVE PROCEDURE, ON THE FINAL FIRING ON THE FUNDUS, DR HEARD A CRACK WHEN FIRING ON THE FINAL FIRING AND THE STAPLES ON THE PATIENT SIDE DID NOT FORM PROPERLY, EVIDENCE BELOW. THE TISSUE WAS NO THICKER THAN NORMAL, HE WAS NOT USING BUTTRESSING. NOTHING ELSE UNTOWARD. HE OVERSEWED THE STAPLE LINE. THERE WAS NO LEAK THE PATIENT WAS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    170337 GST GREEN RELOAD, 60MM, 6 ROW STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. R40W68 10705036014713

    Patients

    Seq Age Sex Outcome Treatment
    1