BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OLLIF TRAY HOOP CUTTER

    MDR report key: 12385007 · Received August 27, 2021

    Report

    Report Number
    MW5103576
    Event Type
    Malfunction
    Date Received
    August 27, 2021
    Date of Event
    August 25, 2021
    Report Date
    August 26, 2021
    Manufacturer
    ADVANCED RESEARCH MEDICAL
    Product Code
    LRP
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MN, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    WHILE USING THE HOOP CUTTER, THE CUTTER BROKE. BOTH PIECES STAYED ATTACHED TO THE INSTRUMENT. FDA SAFETY REPORT ID # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1275213 OLLIF TRAY HOOP CUTTER TRAY, SURGICAL LRP ADVANCED RESEARCH MEDICAL 01-06-4 REVA BB350AA

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Other