BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OSTEOSTAT STERNAL SAW

    MDR report key: 71775 · Received February 22, 1997

    Report

    Report Number
    1646654-1997-00001
    Event Type
    Malfunction
    Date Received
    February 22, 1997
    Date of Event
    December 1, 1996
    Report Date
    February 20, 1997
    Manufacturer
    SURGIQUIP, INC.
    Product Code
    DWH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    A DECEASED PT WAS UNDERGOING AN ORGAN-DONOR PROCEDURE IN WHICH THE STERNUM SAW WAS USED. DURING THE PROCEDURE, THE BLADE PROTECTOR BROKE OFF THE DEVICE. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE AND THERE WAS NO FURTHER INCIDENT. THE CAUSE OF THE EVENT HAS NOT BEEN DETERMINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OSTEOSTAT STERNAL SAW INSTRUMENT, STERNUM SAW DWH SURGIQUIP, INC. NA 0596SHP01

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other