BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOPATH ENDOSCOPIC VASCULAR LINEAR CUTTER

    MDR report key: 55309 · Received December 9, 1996

    Report

    Report Number
    1527736-1996-00627
    Event Type
    Malfunction
    Date Received
    December 9, 1996
    Date of Event
    August 12, 1996
    Report Date
    December 9, 1996
    Manufacturer
    ETHICON ENDO-SURGERY, INC.
    Product Code
    GAG
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE DEVICE WAS USED DURING A LAPAROSCOPIC ASSISTED VAGINAL HYSTERECTOMY. THE EZ35W WAS FIRED ONCE AND RELOADED. ON THE SECOND FIRING, THE SURGEON CLAMPED ON THE ROUND LIGAMENT AND BROAD LIGAMENT, AND WAS ABOUT TO FIRE WHEN THE SALES REP NOTICED THE ORANGE TAB AND WHITE PLASTIC GUIDE FROM THE EVU35 HAD BROKEN OFF AND LODGED IN THE APEX OF THE EZ35W. AT THE REQUEST OF THE SALES REP THE SURGEON UNCLAMPED AND REMOVED THE DEVICE. THE EVR35 PIECES WERE RETREIEVED FROM THE PT. THE EZ35W WAS SUCCESSFULLY RELOADED FOR A TOTAL OF SEVEN FIRINGS TO COMPLETE THE PROCEDURE. THE EVU35 IS BEING RETURNED FOR ANALYSIS, BUT RETRIEVED PIECES WERE NOT SAVED. THERE WAS NO CONSEQUENCE TO THE PT. 8/15/96 1455 RISK MGR SAID THE PT WAS A FEMALE, AGE 55, BIRTHDATE 10/8/40, 151 POUNDS, MFR #005418.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOPATH ENDOSCOPIC VASCULAR LINEAR CUTTER ENDOSCOPIC VASCULAR LINEAR CUT GAG ETHICON ENDO-SURGERY, INC. NA J43726

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Other
    2 *