BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOPATH ENDOSCOPIC LINEAR CUTTER

    MDR report key: 44095 · Received October 17, 1996

    Report

    Report Number
    1527736-1996-00288
    Event Type
    Malfunction
    Date Received
    October 17, 1996
    Date of Event
    September 19, 1996
    Report Date
    October 17, 1996
    Manufacturer
    ETHICON ENDO-SURGERY, INC.
    Product Code
    GAG
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    9/24/96 THE SURGEON STATED HE ACCIDENTALLY PARTIALLY FIRED THE BLACK HANDLE. IT WOULD NOT STAPLE OR CUT. HE FELT THERE SHOULD BE A SAFETY MECHANISM IN PLACE TO PREVENT THIS. HE OPENED ANOTHER DEVICE AND IT WORKED FINE. KJB

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOPATH ENDOSCOPIC LINEAR CUTTER ENDOSCOPIC LINEAR CUTTER GAG ETHICON ENDO-SURGERY, INC. NA H41E2M

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other