BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HD AUTOCLAVABLE CAMERA HEAD

    MDR report key: 11853436 · Received May 19, 2021

    Report

    Report Number
    8010047-2021-06518
    Event Type
    Malfunction
    Date Received
    May 19, 2021
    Report Date
    June 30, 2021
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    FET
    PMA / PMN Number
    K102059
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    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. THE EXACT CAUSE OF THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED. OMSC SURMISED THAT THIS PHENOMENON ATTRIBUTED TO A FAILURE OF THE CABLE UNIT 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. OLYMPUS REPAIR CENTER FOUND THAT THERE WAS INTERFERENCE ON THE IMAGE WHEN THE CABLE WAS MOVED. OLYMPUS REPAIR CENTER CONSIDERED THAT THE CABLE WAS DAMAGED INTERNALLY. THE DEVICE TIGHTNESS WAS LOST DUE TO THE THREADS OF THE OPTICS RETENTION COUPLER. THERE WERE TRACES OF RUST AT COUPLER OPTICS. THE EXACT CAUSE OF THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED AT THIS TIME. IF SIGNIFICANT ADDITIONAL INFORMATION IS RECEIVED, THIS REPORT WILL BE SUPPLEMENTED.

    Description of Event or Problem · 1

    DURING NEPHRECTOMY, THE USER FOUND THAT THE ENDOSCOPIC IMAGE WAS NOT DISPLAYED AND GREEN STRIPES WERE DISPLAYED ON THE MONITOR. THE USER REPLACED THE DEVICE WITH ANOTHER DEVICE AND COMPLETED THE PROCEDURE. THE PROCEDURE WAS EXTENDED FOR 30 MINUTES. THERE WAS NO REPORT OF PATIENT INJURY ASSOCIATED WITH THIS EVENT. THE OPERATING ROOM SUPERVISOR OF THE USER FACILITY COMMENTED THAT THIS DEVICE WAS BROKEN IN PROCESSES WITH A LOT OF LIQUID SUCH AS UROLOGY. THERE WAS A POSSIBILITY THAT THE WATER-TIGHTNESS OF THE DEVICE WAS LOST AND THE INSIDE CARD GOT WET AND RUST. THE USER FACILITY DID NOT PROVIDE OTHER DETAILED INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    745520 HD AUTOCLAVABLE CAMERA HEAD AUTOCLAVABLE CAMERA HEAD FET OLYMPUS MEDICAL SYSTEMS CORP. CH-S190-XZ-E

    Patients

    Seq Age Sex Outcome Treatment
    1