BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROXIMATE

    MDR report key: 13235564 · Received January 12, 2022

    Report

    Report Number
    13235564
    Event Type
    Malfunction
    Date Received
    January 12, 2022
    Date of Event
    June 18, 2021
    Report Date
    January 5, 2022
    Manufacturer
    ETHICON ENDO-SURGERY, LLC
    Product Code
    GDW
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    MD WAS USING THE TLC75 75MM LINEAR CUTTER, DURING THE 3RD USE, IT MISFIRED, BLADE WOULD NOT ADVANCE DURING MID-DEPLOYMENT. THE STAPLES WERE NOT FIRED, THE STAPLES CAME OUT IN AN "U" SHAPE NOT THE "B" SHAPE. THIS IS A DISPOSABLE, STAPLER, THEREFORE ANOTHER STAPLER WAS OPENED AND NOT CHARGED TO PATIENT. THIS PARTICULAR STAPLER: LOT#U40T59, #TLC75. TYPE OF SURGERY/PROCEDURE SCHEDULED: ILEOSTOMY TAKEDOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    802836 PROXIMATE STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC TLC75 U40T59

    Patients

    Seq Age Sex Outcome Treatment
    1 29200 DA Female