BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOPATH ENDOSCOPIC VASCULAR LINEAR CUTTER

    MDR report key: 56421 · Received September 25, 1996

    Report

    Report Number
    1527736-1996-00131
    Event Type
    Malfunction
    Date Received
    September 25, 1996
    Date of Event
    August 1, 1996
    Report Date
    September 12, 1996
    Manufacturer
    ETHICON ENDO-SURGERY, INC.
    Product Code
    GAG
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE DEVICE WAS USED DURING A L.A.V.H. PROCEDURE. IT WAS REPORTED THE SURGEON ATTEMPTED TO FIRE THE EZ35W, BUT IT WOULD NOT FIRE. ANOTHER EZ35W WAS OPENED TO COMPLETE THE PROCEDURE. THERE WAS NO CONSEQUENCE TO THE PT. 09/04/96 0715 IT WAS REPORTED NO BUTTRESSING MATERIAL WAS USED DURING THIS PROCEDURE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN