BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOPATH ENDOSCOPIC ARTICULATING LINEAR CUTTER - 35 MM

    MDR report key: 639134 · Received July 25, 2005

    Report

    Report Number
    1527736-2005-03258
    Event Type
    Malfunction
    Date Received
    July 25, 2005
    Date of Event
    January 4, 2005
    Report Date
    July 12, 2005
    Manufacturer
    ETHICON ENDO SURGERY, INC. (CINCINNATI)
    Product Code
    KOG
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN OPERATIVE LAPAROSCOPY WITH LSO PROCEDURE, THE HANDLE WOULD NOT RELEASE WITH THE FOURTH RELOAD IN IT. THE CASE WAS COMPLETED WITH ANOTHER DEVICE OF THE SAME PRODUCT CODE. NO PT CONSEQUENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOPATH ENDOSCOPIC ARTICULATING LINEAR CUTTER - 35 MM ENDOSCOPIC LINEAR CUTTERS KOG ETHICON ENDO SURGERY, INC. (CINCINNATI) NA V4334T

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN