BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOPATH ETS FLEX45 ENDOSCOPIC ARTICULATING LINEAR

    MDR report key: 599354 · Received May 2, 2005

    Report

    Report Number
    1527736-2005-01901
    Event Type
    Malfunction
    Date Received
    May 2, 2005
    Date of Event
    April 8, 2005
    Report Date
    April 11, 2005
    Manufacturer
    ETHICON ENDO-SURGERY, INC.
    Product Code
    GCJ
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAP HSO PROCEDURE, THE SURGEON STATES TAH THE DEVICE CRUNCHED WHILE FIRING AND THE STAPLES DID NOT FORM PROPERLY. CASE COMPLETED WITH ANOTHER DEVICE OF THE SAME PRODUCT CODE. NO PATIENT CONSEQUENCE. ONE DEVICE RETURNING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOPATH ETS FLEX45 ENDOSCOPIC ARTICULATING LINEAR ENDO LINEAR CUTTERS - ETS45MM GCJ ETHICON ENDO-SURGERY, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN