BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNERGETICS

    MDR report key: 20425768 · Received October 11, 2024

    Report

    Report Number
    20425768
    Event Type
    Malfunction
    Date Received
    October 11, 2024
    Date of Event
    August 14, 2024
    Report Date
    October 10, 2024
    Manufacturer
    SYNERGETICS, INC.
    Product Code
    HQR
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    ME
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    FROM STAFF: SYNERGETICS BIPOLAR CAUTERY 25GA WAS OPENED TO THE FIELD AND THE CST NOTED THE WIRING COVERING DID NOT EXTEND TO WHERE IT SHOULD HAVE, EXPOSING SOME OF THE 'WIRE/CONNECTOR'. THE INSTRUMENT WAS TAKEN OFF THE FIELD AND REPLACED WITH ANOTHER. NO HARM TO ANYONE OR ANYTHING, JUST A SLIGHT DELAY TO GET ANOTHER INSTRUMENT AND OPEN IT TO THE FIELD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    294085 SYNERGETICS APPARATUS, CAUTERY, RADIOFREQUENCY, AC-POWERED HQR SYNERGETICS, INC. 53.00.25 M0054255

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Female