BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MICROAIRE ENDOSCOPIC KITS

    MDR report key: 16887515 · Received May 5, 2023

    Report

    Report Number
    MW5117324
    Event Type
    Injury
    Date Received
    May 5, 2023
    Date of Event
    April 18, 2022
    Report Date
    April 28, 2023
    Manufacturer
    MICROAIRE SURGICAL INSTRUMENTS LLC..
    Product Code
    HRX
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IL, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    MICROAIRE WAS BEING USED FOR ENDOSCOPIC CUBITAL TUNNEL RELEASE. THIS COMPANY MAKES THE COMPONENTS IN THE ENDOSCOPIC KITS. THE PATIENT FOUND TO HAVE ULNAR NERVE INJURY POST-OP THAT REQUIRED SURGICAL INTERVENTION; 1/2 CASES FOR THE PROVIDER USING THIS NEW KIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    883250 MICROAIRE ENDOSCOPIC KITS ARTHROSCOPE HRX MICROAIRE SURGICAL INSTRUMENTS LLC..

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Female Required Intervention