BEUDAMED
    FDA Adverse Event Other Summary report: N

    SONY DXC-970MD

    MDR report key: 466551 · Received June 13, 2003

    Report

    Report Number
    2246606-2003-00001
    Event Type
    Other
    Date Received
    June 13, 2003
    Date of Event
    February 1, 2003
    Report Date
    June 13, 2003
    Manufacturer
    SONY EMCS CORP KOSAI TEC
    Product Code
    KQM
    Report Source
    Distributor report
    Reporter Location
    JA
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    THE LENS OF A SONY DXC-950 CAMERA INTERGRATED INTO A SURGICAL SYSTEM MANUFACTURED BY AN AS YET-TO-BE-IDENTIFIED NON-SONY ENTITY, FELL OUT AND STRUCK A PT UNDERGOING A PROCEDURE. THE SEVERITY OF THE INJURY TO THE PT WAS NOT REPORTED. THE DXC-950 CAMERA IS NOT ITSELF A MEDICAL DEVICE AS DEFINED BY THE FOOD, DRUG AND COSMETIC ACT, AS AMENDED, HOWEVER, A SISTER PRODUCT, THE DXC-970MD IS MARKETED BY THE SONY MEDICAL DIVISION OF SONY ELECTRONICS, INC AS A MEDICAL DEVICE. ALTHOUGH THERE HAVE BEEN NO REPORTS OF A LENS FALLING OFF A DXC-970MD CAMERA, SONY MEDICAL DIVISION HAS INITIATED AN INVESTIGATION AS TO WHETHER SOMETHING SIMILAR COULD OCCUR AND, IF SO, WHAT CORRECTIVE ACTION SHOULD BE TAKEN. HOWEVER, IT APPEARS THAT THERE WAS NO INHERENT PROBLEM WITH THE DXC-950 CAMERA INVOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SONY DXC-970MD VIDEO CAMERA KQM SONY EMCS CORP KOSAI TEC DXC-970MD NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO Other