BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOPATH ENDOSCOPIC VASCULAR LINEAR CUTTER

    MDR report key: 83077 · Received April 3, 1997

    Report

    Report Number
    1527736-1997-00474
    Event Type
    Malfunction
    Date Received
    April 3, 1997
    Date of Event
    March 14, 1996
    Report Date
    April 3, 1997
    Manufacturer
    ETHICON ENDO-SURGERY, INC.
    Product Code
    GAG
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    RECEIVED MEDWATCH #1010737 3/3/97 STATING "ENDOSCOPIC RELOADABLE LINEAR CUTTER RELOADED TWICE AND FUNCTIONED CORRECTLY. MISFIRED ON THIRD RELOAD. MALFUNCTION NECESSITATED ADDITIONAL ARTERY REPAIR, AND RESULTING BLOOD LOSS NOTED." 3/13/97 SPOKE WITH SALES REP WHO WAS ADVISED BY RISK MANAGER REPORTED THESE TO FDA IN APRIL OF 96 AND INSTRUMENTS ARE NO LONGER AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOPATH ENDOSCOPIC VASCULAR LINEAR CUTTER ENDOSCOPIC LINEAR CUTTER GAG ETHICON ENDO-SURGERY, INC. NA J41W8D

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Other