BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYMMETRY

    MDR report key: 8288567 · Received January 30, 2019

    Report

    Report Number
    8288567
    Event Type
    Malfunction
    Date Received
    January 30, 2019
    Date of Event
    November 27, 2018
    Report Date
    January 3, 2019
    Manufacturer
    OLSEN MEDICAL
    Product Code
    HAM
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    DURING SURGICAL SPINE PROCEDURE, THE DOCTOR WAS USING A DISPOSABLE INSULATED BAYONET FORCEPS, AND STATED THAT THEY WERE NOT WORKING. IT WAS INITIALLY PLUGGED INTO THEIR PREFERRED UNIT (CODMAN). DOCTOR SAID IT SEEMED IT WAS WORKING, THEN STOPPED, WORKING ,STOPPED. THEY DESCRIBED THE MALFUNCTION AS A "SHORT CIRCUIT-- SOMETHING'S WRONG WITH THE CONNECTION." ACTION TAKEN BY RN, WHO SWITCHED TO A DIFFERENT CAUTERY MACHINE ( X2) I SWITCHED FOOT PEDALS (X 2). RN OPENED NEW BAYONET FORCEPS ( X2) I THEN OPENED A THIRD AND CHECKED IT WAS A NEW LOT NUMBER AND WORKED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    81342 SYMMETRY APPARATUS, ELECTROSURGICAL HAM OLSEN MEDICAL 108638

    Patients

    Seq Age Sex Outcome Treatment
    1 21535 DA