BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAMERA HEAD

    MDR report key: 19595720 · Received June 24, 2024

    Report

    Report Number
    3002808148-2024-34253
    Event Type
    Malfunction
    Date Received
    June 24, 2024
    Date of Event
    June 10, 2024
    Report Date
    June 24, 2024
    Manufacturer
    SHIRAKAWA OLYMPUS CO., LTD.
    Product Code
    FET
    UDI-DI
    04953170141614
    PMA / PMN Number
    K955404
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE PRODUCT WAS RETURNED TO OLYMPUS AND THE FOLLOWING REPORTABLE MALFUNCTION WAS IDENTIFIED DURING THE DEVICE EVALUATION: SCRATCHES ON THE CHARGED COUPLED DEVICE COVER GLASS. BASED ON THE RESULTS OF THE INVESTIGATION, A PROBABLE ROOT CAUSE OF THE ISSUE COULD NOT BE DETERMINED. A DEVICE HISTORY RECORD REVIEW REVEALED NO ISSUES THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED ISSUE. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Description of Event or Problem · 0

    IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE CAMERA HEAD EXHIBITED SCRATCHES ON CHARGED COUPLED DEVICE COVER GLASS. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1654562 CAMERA HEAD CAMERA HEAD FET SHIRAKAWA OLYMPUS CO., LTD. OTV-S7H-1N 04953170141614

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown