BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OSTEOSTAT STERNAL SAW

    MDR report key: 132957 · Received November 17, 1997

    Report

    Report Number
    2219689-1997-00636
    Event Type
    Malfunction
    Date Received
    November 17, 1997
    Date of Event
    August 5, 1997
    Report Date
    November 13, 1997
    Manufacturer
    SURGIQUIP INC.
    Product Code
    DWH
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE BLADE GUARD BROKE OFF DURING SURGERY. THERE WAS NO ADVERSE CONSEQUENCE FOR THE PT OR DELAY IN SURGERY OR ANESTHAESIA TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OSTEOSTAT STERNAL SAW INSTRUMENT DWH SURGIQUIP INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other