BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HD AUTOCLAVABLE CAMERA HEAD

    MDR report key: 24638433 · Received March 19, 2026

    Report

    Report Number
    3002808148-2026-07378
    Event Type
    Malfunction
    Date Received
    March 19, 2026
    Report Date
    March 19, 2026
    Manufacturer
    SHIRAKAWA OLYMPUS CO., LTD.
    Product Code
    FET
    UDI-DI
    04953170310799
    PMA / PMN Number
    K102059
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION IS ONGOING. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETED OR IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE AUTOCLAVABLE CAMERA HEAD HAD A SCOPE COMMUNICATION ERROR E315. THERE WERE NO REPORTS OF PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    704189 HD AUTOCLAVABLE CAMERA HEAD AUTOCLAVABLE CAMERA HEAD FET SHIRAKAWA OLYMPUS CO., LTD. CH-S190-XZ-E 04953170310799

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown