BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAMERA HEAD

    MDR report key: 11722546 · Received April 26, 2021

    Report

    Report Number
    8010047-2021-05367
    Event Type
    Malfunction
    Date Received
    April 26, 2021
    Date of Event
    March 25, 2021
    Report Date
    May 25, 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

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE ADDITIONAL INFORMATION.THE DEVICE WAS RETURNED TO OLYMPUS REPAIR CENTER, BUT NOT RETURNED TO OLYMPUS MEDICAL SYSTEMS CORP. (OMSC). THEREFORE, OMSC COULD NOT CONFIRM THE DEVICE. DEVICE HISTORY RECORD REVIEW INDICATES THAT THE PRODUCT WAS MANUFACTURED AND TESTED IN ACCORDANCE WITH ALL APPLICABLE PROCEDURES AND MET ALL FINAL PRODUCT RELEASE CRITERIA. OMSC SURMISED THAT THIS PHENOMENON ATTRIBUTED TO THE BROKEN CABLE BY THE USER HANDLING. IF SIGNIFICANT ADDITIONAL INFORMATION IS RECEIVED, THIS REPORT WILL BE SUPPLEMENTED.

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED TO OLYMPUS MEDICAL SYSTEMS CORP. (OMSC), BUT RETURNED TO OLYMPUS REPAIR CENTER FOR EVALUATION. ACCORDING TO THE EVALUATION, THE FOLLOWING WAS FOUND: THE CABLE COVER WAS BROKEN. THE ENDOSCOPIC IMAGE WAS FLICKERED WITH STRIPE NOISES OR DISAPPEARED. CCD WAS CORRODED AND SOME BLACK DOTS OCCURRED TO THE ENDOSCOPIC IMAGE. THE CABLE HAD A FAILURE. THE EXACT CAUSE OF THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED AT THIS TIME. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE SUPPLEMENTED.

    Description of Event or Problem · 1

    DURING HYSTEROSCOPY, THE USER FOUND THAT THE ENDOSCOPIC IMAGE BECAME ABNORMAL. THE USER COMPLETED THE PROCEDURE WITH THE DEVICE. THERE WAS NO REPORT OF PATIENT INJURY ASSOCIATED WITH THIS EVENT. THE USER FACILITY DID NOT PROVIDE OTHER DETAILED INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    623805 CAMERA HEAD CAMERA HEAD FET OLYMPUS MEDICAL SYSTEMS CORP. OTV-S7H-N

    Patients

    Seq Age Sex Outcome Treatment
    1