BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MICROAIRE

    MDR report key: 672600 · Received February 6, 2006

    Report

    Report Number
    2020601-2006-00003
    Event Type
    Injury
    Date Received
    February 6, 2006
    Date of Event
    November 22, 2005
    Report Date
    February 6, 2006
    Manufacturer
    MICROAIRE SURGICAL INSTRUMENTS, LLC
    Product Code
    HRX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    REPORT INDICATED: "WHILST DOING AN ENDOSCOPIC BILATERAL CARPAL TUNNEL RELEASE, THE ENDOSCOPIC BLADE (CODE 81010) BROKE INSIDE THE PATIENT, AND A PIECE OF THE BLACK PART OF THE BLADE WAS LODGED IN THE PATIENT. WE HAD TO OPEN THE SECOND BLADE TO COMPLETE THE PROCEDURE, AND MANAGED TO TAKE THE PIECE LODGED IN THE PATIENT OUT."

    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 53 YR Required Intervention