BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOPATH ETS

    MDR report key: 280838 · Received June 1, 2000

    Report

    Report Number
    1527736-2000-02391
    Event Type
    Malfunction
    Date Received
    June 1, 2000
    Date of Event
    April 27, 2000
    Report Date
    May 5, 2000
    Manufacturer
    ETHICON ENDO-SURGERY
    Product Code
    KOG
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE RISK MANAGER THAT THE PRODUCT WAS USED IN A LAPAROSCOPIC APPENDECTOMY. IT WAS REPORTED THAT THE INSTRUMENT (TSB45) WAS FIRED ACROSS THE APPENDIX AND THERE WAS BLEEDING. THE BLEEDING STOPPED AFTER A CLIP APPLIER WAS USED. THERE WAS NO CONSEQUENCE TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOPATH ETS LINEAR CUTTERS - ENDOSCOPIC KOG ETHICON ENDO-SURGERY NA NEGD99

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other