BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FORMULA AGGRESSIVE PLUS

    MDR report key: 6166303 · Received December 12, 2016

    Report

    Report Number
    6166303
    Event Type
    Malfunction
    Date Received
    December 12, 2016
    Date of Event
    November 10, 2016
    Report Date
    November 14, 2016
    Manufacturer
    STRYKER ENDOSCOPY
    Product Code
    NBH
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DURING PROCEDURE, WHILE USING THE SHAVER DEVICE, THE METAL SHAVER PIECES APPEARED TO DISLODGE FROM THE SHAVER WITH SMALL PIECES ENTERING THE SURGICAL CAVITY. A NEW SHAVER WAS UTILIZED. THE AREA WAS IRRIGATED AND PIECES OF METAL WERE REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    817807 FORMULA AGGRESSIVE PLUS ACCESSORIES, ARTHROSCOPIC NBH STRYKER ENDOSCOPY 5079175

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Other