BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HD AUTOCLAVABLE CAMERA HEAD

    MDR report key: 16616575 · Received March 25, 2023

    Report

    Report Number
    3002808148-2023-02989
    Event Type
    Malfunction
    Date Received
    March 25, 2023
    Date of Event
    February 23, 2023
    Report Date
    May 20, 2023
    Manufacturer
    SHIRAKAWA OLYMPUS CO., LTD.
    Product Code
    FET
    UDI-DI
    04953170228834
    PMA / PMN Number
    K955404
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION - B5/H6 (CORRECTED MEDICAL DEVICE PROBLEM CODE). THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION BASED ON THE LEGAL MANUFACTURER'S FINAL INVESTIGATION. A REVIEW OF THE DEVICE HISTORY RECORD FOUND NO DEVIATIONS THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED ISSUE. THE INVESTIGATION DETERMINED THE LIKELY CAUSE OF THE FLICKERING IMAGE WAS A LOOSE/DEFORMED COUPLER. THE CAUSE OF THE LOOSE/DEFORMED COUPLER COULD NOT BE DETERMINED. OLYMPUS WILL CONTINUE TO MONITOR THE FIELD PERFORMANCE OF THIS DEVICE.

    Additional Manufacturer Narrative · 0

    INITIAL REPORTER NAME AND ADDRESS: (B)(6) UNIVERSITY MEDICAL COLLEGE. THE DEVICE WAS RETURNED TO OLYMPUS FOR EVALUATION AND THE CUSTOMER¿S ALLEGATION WAS CONFIRMED. THE IMAGE WAS OFFSET SOMETIMES DUE TO A LOOSE CARD LOCK, HOWEVER, THE OBJECT WAS VISIBLE. THE CARD LOCK WAS LOOSE DUE TO DEFORMED COUPLER. ADDITIONAL INFORMATION HAS BEEN REQUESTED REGARDING THIS EVENT. THE INVESTIGATION IS PENDING. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION OR IF ANY ADDITIONAL INFORMATION IS PROVIDED BY THE USER FACILITY.

    Description of Event or Problem · 0

    THE EVENT DID NOT OCCUR DURING A PROCEDURE AS PREVIOUSLY REPORTED.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED TO OLYMPUS THAT DURING A UNKNOWN PROCEDURE, THE LOCK WAS LOOSE ON THE HD AUTOCLAVABLE CAMERA HEAD, RESULTING IN THE IMAGE FLICKERING. THE PROCEDURE WAS COMPLETED USING A SIMILAR DEVICE. THERE WAS NO DELAY IN THE PROCEDURE AND THE PATIENT WAS NOT UNDER SEDATION AT THE TIME OF THE FAILURE. THERE WAS NO PATIENT HARM ASSOCIATED WITH THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    521725 HD AUTOCLAVABLE CAMERA HEAD CAMERA HEAD FET SHIRAKAWA OLYMPUS CO., LTD. OTV-S7PROH-HD-12E 04953170228834

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown OTV-S190