BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOPATH ETS

    MDR report key: 98814 · Received May 2, 1997

    Report

    Report Number
    1527736-1997-00842
    Event Type
    Malfunction
    Date Received
    May 2, 1997
    Date of Event
    January 27, 1997
    Report Date
    May 1, 1997
    Manufacturer
    ETHICON ENDO-SURGERY, INC.
    Product Code
    KOG
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THE INSTRUMENT WAS USED DURING A LAPAROSCOPICALLY ASSISTED VAGINAL HYSTERECTOMY. THE SCRUB ASSISTANT REPORTED THE METAL BOTTOM OF THE RELOADS CAME LOOSE FROM THE PLASTIC PORTION OF THE CARTRIDGE WHEN REMOVAL WAS ATTEMPTED, LEAVING THE METAL PIECE STILL ATTACHED TO INSIDE OF STAPLER JAWS. LAST ATTEMPTED FIRING RESULTED IN UNIFORMED STAPLES. THERE WAS NO CONSEQUENCE TO THE PT. 01/31/97 1403 MESSAGE AND 800# LEFT FOR MD CALL BACK. 2/3/97 1835 NNCL SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOPATH ETS LINEAR CUTTER KOG ETHICON ENDO-SURGERY, INC. NA J4573L

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other