BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOPATH ENDOSCOPIC LINEAR CUTTER - ETS45MM

    MDR report key: 612869 · Received July 21, 2004

    Report

    Report Number
    1527736-2004-02246
    Event Type
    Malfunction
    Date Received
    July 21, 2004
    Date of Event
    June 28, 2004
    Report Date
    June 28, 2004
    Manufacturer
    ETHICON ENDO-SURGERY, INC. (CINCINNATI)
    Product Code
    KOG
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A MNI BYPASS PROCEDURE, THE DEVICE DELIVERED MALFORMED STAPLES. THE OPERATING ROOM TIME WAS EXTENDED BY AN UNK AMOUNT OF TIME. THERE WAS NO REPORTED PT CONSEQUENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOPATH ENDOSCOPIC LINEAR CUTTER - ETS45MM ENDOSCOPIC LINEAR CUTTER KOG ETHICON ENDO-SURGERY, INC. (CINCINNATI) NA V4ZV2P

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN