BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAUTERY CORD

    MDR report key: 10100827 · Received May 29, 2020

    Report

    Report Number
    10100827
    Event Type
    Malfunction
    Date Received
    May 29, 2020
    Date of Event
    January 21, 2020
    Report Date
    April 3, 2020
    Manufacturer
    OLSEN MEDICAL LLC
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    OK
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PATIENT WAS UNDERGOING A LAPAROSCOPIC CHOLECYSTECTOMY UNDER GENERAL ANESTHESIA. ONE OF THE CAUTERY CORDS THAT IS PACKAGED IN-HOUSE WITH THE LAP CHOLE SET ((B)(4)) WAS IN USE AND WORKING NORMALLY WHEN THE SURGEON NOTED THAT IT SUDDENLY CEASED WORKING. UPON INSPECTION OF THE CORD BY THE SURGEON AND THE SCRUB TECH, THEY REALIZED THE CORD HAD BURN COMPLETELY THROUGH, FRACTURING THE CORD INTO TWO (2) PIECES. NO INJURY TO PATIENT OR STAFF. CAUTERY UNIT SET ON "NORMAL CAUTERY LEVEL."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    567186 CAUTERY CORD ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI OLSEN MEDICAL LLC 8S-9199 038650

    Patients

    Seq Age Sex Outcome Treatment
    1 13505 DA