BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STRYKER ENDOSCOPY

    MDR report key: 2030821 · Received March 23, 2011

    Report

    Report Number
    MW5019930
    Event Type
    Malfunction
    Date Received
    March 23, 2011
    Date of Event
    March 15, 2011
    Report Date
    March 15, 2011
    Product Code
    GFA
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    SD, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DOING KNEE ARTHROSCOPY - SHAVER 4.0 IN PT KNEE IT BROKE. TIP OF SHAVER BROKE OFF IN PT KNEE. PHYSICIAN ABLE TO REMOVE TIP FROM PT KNEE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STRYKER ENDOSCOPY AGGRESSIVE PLUS 4.0MM SHAVER GFA 11005CE2

    Patients

    Seq Age Sex Outcome Treatment
    1 21 YR