BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HD AUTOCLAVABLE CAMERA HEAD

    MDR report key: 12180568 · Received July 16, 2021

    Report

    Report Number
    8010047-2021-08959
    Event Type
    Malfunction
    Date Received
    July 16, 2021
    Date of Event
    June 22, 2021
    Report Date
    September 8, 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 · 0

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE THE SUBJECT DEVICE EVALUATION RESULT. THE SUBJECT DEVICE WAS NOT RETURNED TO OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) FOR EVALUATION BUT WAS RETURNED TO OLYMPUS AUSTRALIA AND NEW ZEALAND (OAZ). OMSC REVIEWED THE DEVICE HISTORY RECORD (DHR) OF THE SUBJECT DEVICE AND CONFIRMED NO IRREGULARITY. BASED UPON THE INFORMATION FROM OAZ, OMSC CONCLUDED THAT THE REPORTED PHENOMENON WAS ATTRIBUTED TO THE POWER COULD NOT BE SUPPLIED NORMALLY DUE TO THE FAILURE OF THE CABLE.

    Additional Manufacturer Narrative · 1

    THE SUBJECT DEVICE WAS NOT RETURNED TO OMSC FOR EVALUATION BUT WAS RETURNED TO OLYMPUS (B)(6) AND (B)(6) (OAZ). OAZ CHECKED THE SUBJECT DEVICE AND FOUND THAT THE REPORTED PHENOMENON WAS DUPLICATED DUE TO THE FAILURE OF THE CABLE. 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 PREPARATION FOR USE, IT WAS FOUND THAT THE ENDOSCOPIC IMAGE OF THE SUBJECT DEVICE BLACKED OUT. THERE WAS NO REPORT OF PATIENT INJURY ASSOCIATED WITH THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1080237 HD AUTOCLAVABLE CAMERA HEAD CAMERA HEAD FET OLYMPUS MEDICAL SYSTEMS CORP. OTV-S7PROH-HD-12E

    Patients

    Seq Age Sex Outcome Treatment
    1