BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRAY, SURGICAL, INSTRUMENT

    MDR report key: 23015029 · Received September 10, 2025

    Report

    Report Number
    23015029
    Event Type
    Malfunction
    Date Received
    September 10, 2025
    Date of Event
    August 21, 2025
    Report Date
    August 21, 2025
    Manufacturer
    STRAUSS SURGICAL USA LLC.
    Product Code
    FSM
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    BLACK PLASTIC LEFT SIDE OF ELECTRODE BROKE OFF DURING THE PROCEDURE. ALL PIECES OF PRODUCT ACCOUNTED FOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2488943 TRAY, SURGICAL, INSTRUMENT FSM STRAUSS SURGICAL USA LLC.

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Male