BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GST BLUE RELOAD, 45MM, 6 ROW

    MDR report key: 7260790 · Received February 9, 2018

    Report

    Report Number
    3005075853-2018-07911
    Event Type
    Malfunction
    Date Received
    February 9, 2018
    Date of Event
    January 1, 2018
    Report Date
    January 18, 2018
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K163454
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). PHOTOGRAPHIC ANALYSIS: TWO PICTURES WERE PROVIDED; FIRST PICTURE SHOWS A DRAWING OF THE STOMACH, SIMULATING THE DISSECTION OF THE FUNDUS IN A PERPENDICULAR ANGLES. SECOND PICTURE SHOWS TISSUE WITH A STAPLE LINE, ON THE BOTTOM APPEARS TO BE STAPLE LEGS. BASED ON THE PHOTO ALONE 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

    (B)(4). BATCH # UNK. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT FOR STOMACH BYPASS SURGERY, PROF. USED GST45 RELOADS. WHEN HE DISSECT THE FUNDUS OF STOMACH IN A PERPENDICULAR ANGLES USING TWO GST45B AND TWO GST45D, HE FOUND FLAT STAPLES STICKING OUT (AT THE DISTAL PART OF RELOAD). FROM PROXIMAL TO THE NEAR DISTAL RELOADS ARE FINELY STAPLED. HE REMOVED MAL-FORMED STAPLES FROM THE BODY USING ENDO-GRASPERS. AND, HE FINISHED THE SURGERY SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    102701 GST BLUE RELOAD, 45MM, 6 ROW STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC.

    Patients

    Seq Age Sex Outcome Treatment
    1