BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MICROAIRE

    MDR report key: 521065 · Received April 16, 2004

    Report

    Report Number
    2020601-2004-00001
    Event Type
    Injury
    Date Received
    April 16, 2004
    Report Date
    March 18, 2004
    Manufacturer
    MICROAIRE SURGICAL INSTRUMENTS, LLC
    Product Code
    HRX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    MICROAIRE REC'D A REPORT CLAIMING THAT A PT SUFFERED COMMON DIGITAL NERVE DAMAGE DURING AN ENDOSCOPIC LIGAMENT RELEASE PROCEDURE IN AN ACADEMIC ENVIRONMENT. THE REPORT INDICATED THAT A RESIDENT WAS BEING INSTRUCTED ON THE PROCEDURE BY A TRAINED HEALTH PROFESSIONAL WHEN THE EVENT OCCURRED. NO DEVICE MALFUNCTION WAS REPORTED AND NO ADD'L INFO WAS GIVEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MICROAIRE CARPAL TUNNEL RELEASE SYSTEM BLADE ASSEMBLY HRX MICROAIRE SURGICAL INSTRUMENTS, LLC 81010 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention