BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAMERA HEAD

    MDR report key: 12413204 · Received September 2, 2021

    Report

    Report Number
    8010047-2021-11138
    Event Type
    Malfunction
    Date Received
    September 2, 2021
    Date of Event
    May 10, 2021
    Report Date
    September 2, 2021
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    FET
    PMA / PMN Number
    K955404
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS EVALUATED AT OLYMPUS (B)(4). (B)(4) INSPECTED THE DEVICE AND FOUND THAT THE ENDOSCOPIC IMAGE WAS NOT DISPLAYED DUE TO A BROKEN CAMERA CABLE. THE EXACT CAUSE OF THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED, BECAUSE THE DEVICE HAS NOT BEEN RETURNED TO OLYMPUS MEDICAL SYSTEMS CORP. (OMSC). HOWEVER, IT IS POSSIBLE THAT THE ENDOSCOPIC IMAGE WAS NOT DISPLAYED BECAUSE THE VIDEO COMMUNICATION COULD NOT BE TRANSMITTED TO THE VIDEO SYSTEM CENTER DUE TO THE DAMAGED CAMERA CABLE. OMSC CHECKED THE PRODUCT SHIPMENT RECORD AND FOUND NO ABNORMALITIES ON THE DEVICE. THEREFORE, THE CAMERA CABLE BREAKAGE MAY HAVE BEEN CAUSED BY THE USER'S HANDLING. THE INSTRUCTION MANUAL PROVIDES PREVENTIVE MEASURES AGAINST DAMAGE TO THE CAMERA CABLE. DEVICE HISTORY RECORD (DHR) REVIEW INDICATES THAT THE PRODUCT WAS MANUFACTURED AND TESTED IN ACCORDANCE WITH ALL APPLICABLE PROCEDURES AND MET ALL FINAL PRODUCT RELEASE CRITERIA. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE SUPPLEMENTED.

    Description of Event or Problem · 0

    OLYMPUS (B)(4) CO., LTD. REPORTED THAT THE ENDOSCOPIC IMAGE WAS NOT DISPLAYED. THE DEVICE WAS USED IN COMBINATION WITH A STANDARD SET. THIS DEVICE IS AN OLYMPUS ASSET AND THERE WAS NO REPORT OF PATIENT INJURY ASSOCIATED WITH THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1315002 CAMERA HEAD CAMERA HEAD FET OLYMPUS MEDICAL SYSTEMS CORP. OTV-S7H-1D-F08E

    Patients

    Seq Age Sex Outcome Treatment
    1