BEUDAMED
    FDA Adverse Event Injury Summary report: N

    3MM KERRISON RONGEUR

    MDR report key: 19905909 · Received August 2, 2024

    Report

    Report Number
    MW5157974
    Event Type
    Injury
    Date Received
    August 2, 2024
    Date of Event
    July 30, 2024
    Report Date
    July 31, 2024
    Manufacturer
    LIFE INSTRUMENT CORP.
    Product Code
    HTX
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    KERRISON BROKE WHILE IN USE, NO HARM TO PT, ALL PARTS RETRIEVED AND REMOVED FROM STERILE FIELD. INSTRUMENT REPLACED AND SURGERY PROCEEDED AS PLANNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1704033 3MM KERRISON RONGEUR RONGEUR HTX LIFE INSTRUMENT CORP. 830-0803-0

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Female Required Intervention