BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HD AUTOCLAVABLE CAMERA HEAD

    MDR report key: 12299013 · Received August 10, 2021

    Report

    Report Number
    8010047-2021-10013
    Event Type
    Malfunction
    Date Received
    August 10, 2021
    Date of Event
    July 14, 2021
    Report Date
    August 10, 2021
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    FET
    PMA / PMN Number
    K955404
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SUBJECT DEVICE WAS NOT RETURNED TO OMSC FOR EVALUATION BUT WAS RETURNED TO OLYMPUS AUSTRALIA (OAZ). OAZ CHECKED THE SUBJECT DEVICE AND FOUND THAT THE REPORTED PHENOMENON WAS DUPLICATED, AND ALSO FOUND THAT THE CAMERA CABLE WAS DAMAGED (THERE WAS SIGNS OF TWISTED WIRES) AND THERE WERE CRACKS ON BOTH SIDES OF VIDEO CONNECTOR. OMSC REVIEWED THE MANUFACTURING HISTORY (DHR) OF THE SUBJECT DEVICE AND CONFIRMED NO IRREGULARITY. BASED ON THE INFORMATION FROM OAZ, OMSC CONCLUDED THAT THE REPORTED PHENOMENON WAS ATTRIBUTED TO THE BREAKAGE OF THE VIDEO CONNECTOR OR THE CAMERA CABLE. IT WAS SURMISED THAT THE VIDEO CONNECTOR OR THE CAMERA CABLE BREAKAGE WAS CAUSED BY AN IMPACT SUCH AS THE USER DROPPING THE SUBJECT DEVICE. 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 FACILITY THAT DURING THE ROUTINE MAINTENANCE OF THE SUBJECT DEVICE AT THE USER FACILITY, IT WAS FOUND THAT THE ENDOSCOPIC IMAGE OF THE SUBJECT DEVICE WAS NOT DISPLAYED ON THE MONITOR. THERE WAS NO REPORT OF PATIENT INJURY ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1198264 HD AUTOCLAVABLE CAMERA HEAD CAMERA HEAD FET OLYMPUS MEDICAL SYSTEMS CORP. OTV-S7PROH-HD-10E

    Patients

    Seq Age Sex Outcome Treatment
    1