BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOPATH ETS

    MDR report key: 131169 · Received November 7, 1997

    Report

    Report Number
    1527736-1997-02899
    Event Type
    Malfunction
    Date Received
    November 7, 1997
    Date of Event
    October 7, 1997
    Report Date
    October 9, 1997
    Manufacturer
    ETHICON ENDO-SURGERY, INC.
    Product Code
    KOG
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED DURING A LAPAROSCOPIC APPENDECTOMY THE DOCTOR FIRED THE FIRST FIRING OK. ON THE SECOND FIRING THE GUN APPEARED NOT TO FIRE PROPERLY. WHEN THE JAWS WERE OPENED THE HEMOSTASIS APPEARED WEAK AND THE TR35W FELL OUT OF THE JAW. AN ER320 WAS OPENED TO MAINTAIN HEMOSTASIS. THE RELOAD WAS RETRIEVED FROM THE ABDOMEN. THE CASE WAS COMPLETED LAPAROSCOPICALLY. THE INSTRUMENT WAS DISCARDED BUT TWO RELOADS ARE BEING RETURNED, LOT NUMBER, K01218, BATCH NUMBER K01131. THERE WAS NO CONSEQUENCE TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOPATH ETS LINEAR CUTTER KOG ETHICON ENDO-SURGERY, INC. NA K01218

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other