BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FINE SURGICAL INSTRUMENTS

    MDR report key: 17181231 · Received June 22, 2023

    Report

    Report Number
    17181231
    Event Type
    Malfunction
    Date Received
    June 22, 2023
    Date of Event
    May 30, 2023
    Report Date
    June 13, 2023
    Product Code
    HDJ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NV
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    CORD CLAMP REMOVAL TOOL BROKE WHEN ATTEMPTED TO REMOVE CLAMP. HAD TO MANUALLY REMOVE BROKEN PIECE THAT WAS STUCK IN THE CLAMP. BROKEN CLAMP WAS LABELED AND GIVEN TO NURSING SERVICE MANAGEMENT (NSM).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    80611 FINE SURGICAL INSTRUMENTS SCISSORS, UMBILICAL HDJ 2922

    Patients

    Seq Age Sex Outcome Treatment
    1 0 DA Female