BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAMERA HEAD

    MDR report key: 12285392 · Received August 5, 2021

    Report

    Report Number
    8010047-2021-09852
    Event Type
    Malfunction
    Date Received
    August 5, 2021
    Date of Event
    June 7, 2021
    Report Date
    September 27, 2021
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    FET
    UDI-DI
    04953170142222
    PMA / PMN Number
    K955404
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE ADDITIONAL INFORMATION. THE SUBJECT DEVICE WAS NOT RETURNED TO OMSC FOR EVALUATION BUT WAS RETURNED TO OLYMPUS AUSTRALIA (OAZ) FOR EVALUATION. OAZ CHECKED THE SUBJECT DEVICE AND FOUND THAT THE REPORTED PHENOMENON WAS DUPLICATED DUE TO THE FAILURE OF CABLE. OMSC COULD NOT REVIEWED THE MANUFACTURE HISTORY (DHR) OF THE SUBJECT DEVICE BECAUSE MORE THAN FIFTEEN YEARS HAD PASSED SINCE THE SUBJECT DEVICE HAD BEEN MANUFACTURED. BASED ON THE INFORMATION FROM OAZ, OMSC SURMISED THAT THE REPORTED PHENOMENON WAS ATTRIBUTED TO THE TRANSMISSION FAILURE OF THE IMAGE SIGNAL TO THE VIDEO PROCESSOR DUE TO THE FAILURE OF THE CABLE BY THE USER HANDLING. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE SUPPLEMENTED.

    Additional Manufacturer Narrative · 1

    THE SUBJECT DEVICE IS PLANNED TO BE RETURNED TO OLYMPUS BUT HAS NOT BEEN RETURNED TO OLYMPUS YET. THE EXACT CAUSE OF THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED AT THIS TIME. IF ADDITIONAL INFORMATION IS RECEIVED, THIS REPORT WILL BE SUPPLEMENTED.

    Description of Event or Problem · 1

    OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) WAS INFORMED FROM THE USER THAT DURING THE PREPARATION FOR USE, THE ENDOSCOPIC IMAGE WAS NOT DISPLAYED. THERE WAS NO REPORT OF PATIENT INJURY ASSOCIATED WITH THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1177330 CAMERA HEAD CAMERA HEAD FET OLYMPUS MEDICAL SYSTEMS CORP. OTV-S7H-1D-L08E 04953170142222

    Patients

    Seq Age Sex Outcome Treatment
    1