BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOPATH ENDOSCOPIC MULTIFEED STAPLER

    MDR report key: 280921 · Received June 5, 2000

    Report

    Report Number
    1527736-2000-02426
    Event Type
    Malfunction
    Date Received
    June 5, 2000
    Date of Event
    May 17, 2000
    Report Date
    May 17, 2000
    Manufacturer
    ETHICON ENDO-SURGERY, INC.
    Product Code
    GAG
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT (1) EMS WAS USED DURING A LAP HERNIA PROCEDURE. IT WAS REPORTED BY THE REP THAT THE INSTRUMENT MISFIRED AND JAMMED. REMOVED STAPLE WITH HEMOSTAT. THE SURGEON REPEATED SEVERAL TIMES UNTIL INSTRUMENT WOULD NOT FEED NEW STAPLE AT ALL. OPENED A NEW INSTRUMENT TO COMPLETE THE CASE. THERE WAS NO PT CONSEQUENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOPATH ENDOSCOPIC MULTIFEED STAPLER STAPLERS - ENDOSCOPIC GAG ETHICON ENDO-SURGERY, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other