BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMARTRELEASE

    MDR report key: 24630423 · Received March 18, 2026

    Report

    Report Number
    2020601-2026-00002
    Event Type
    Injury
    Date Received
    March 18, 2026
    Date of Event
    February 18, 2026
    Report Date
    March 18, 2026
    Manufacturer
    MICROAIRE SURGICAL INSTRUMENTS
    Product Code
    EMF
    UDI-DI
    10847399017236
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 0

    81010-1 SMART RELEASE BLADE HAD PIECES BREAKING OFF INTO PATIENT DURING A RIGHT ENDOSCOPIC CARPAL TUNNEL RELEASE PROCEDURE. PATIENT REQUIRED TO GO FROM AN ENDOSCOPIC CARPAL TUNNEL RELEASE PROCEDURE TO AN OPEN CARPAL TUNNEL RELEASE PROCEDURE IN ORDER TO REMOVE THE PIECES THAT BROKE OFF FROM THE 81010-1 SMART RELEASE BLADE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    689954 SMARTRELEASE SMARTRELEASE EMF MICROAIRE SURGICAL INSTRUMENTS 81010-6 107376122025 10847399017236

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Male Required Intervention