BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOPATH ENDOSCOPIC VASCULAR LINEAR CUTTER

    MDR report key: 55865 · Received December 12, 1996

    Report

    Report Number
    1527736-1996-00657
    Event Type
    Malfunction
    Date Received
    December 12, 1996
    Report Date
    December 12, 1996
    Manufacturer
    ETHICON ENDO-SURGERY, INC.
    Product Code
    GAG
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DURING AN EXPLORATORY DIAGNOSTIC LAPAROSCOPY FOR THE RIGHT ECTOPIC PREGNANCY THE SURGEON WAS TRANSECTING THE RIGHT INFUNDIBULOPELVIC LIGAMENT WITH THE DEVICE. THE DEVICE WAS CLOSED AND FIRED AND A "BAD CRACKING SOUND" LIKE THE DEVICE BROKE WAS HEARD. THE JAWS OF THE DEVICE WOULD NOT OPEN. THE SURGEON ATTEMPTED TO PUSH THE RELEASE BUTTON AND PRY THE HANDLES OPEN WITHOUT SUCCESS. A SECOND DEVICE WAS FIRED PROXIMAL TO THE FIRST DEVICE AND CAUTERY WAS USED ON THE MEDIAL SIDE. THE FIRST DEVICE COULD THEN BE REMOVED. ONCE OUT OF THE PT THEY ATTEMPTED TO OPEN THE JAWS OF THE DEVICE WITHOUT SUCCESS. THE DEVICE IS BEING RETURNED WITH TISSUE IN THE JAWS. 11/15/96 0924 SURGEON CALLED BACK AND CONFIRMED THE INFO AS REPORTED BY THE SALES REP. SURGEON STATED THIS OCCURRED ON THE FIRST FIRING. WHEN THE INSTRUMENT WAS CLOSED ON THE TISSUE, IT MADE A NOISE. THEN IT WAS FIRED AND MADE MORE NOISE. THE INSTRUMENT WOULD NOT OPEN. SURGEON HAD TO FIRE ANOTHER INSTRUMENT TWICE, AND USE CAUTERY TO DISSECT THE INSTRUMENT OUT AND CONTROL BLEEDING. THE PT WAS KEPT IN THE HOSP FOR 24 HRS AND WAS DISCHARGED IN STABLE CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOPATH ENDOSCOPIC VASCULAR LINEAR CUTTER ENDOSCOPIC LINEAR CUTTER GAG ETHICON ENDO-SURGERY, INC. NA J44683

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other