BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HD 3CMOS AUTOCLAVABLE CAMERA HEAD

    MDR report key: 12554809 · Received September 30, 2021

    Report

    Report Number
    8010047-2021-12509
    Event Type
    Malfunction
    Date Received
    September 30, 2021
    Date of Event
    September 6, 2021
    Report Date
    December 29, 2021
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    OWN
    PMA / PMN Number
    K200542
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE ADDITIONAL INFORMATION. THE SUBJECT DEVICE WAS RETURNED TO OLYMPUS AUSTRALIA & NEW ZEALAND (OAZ). OMSC CHECKED THE DEVICE HISTORY RECORD OF THE SUBJECT DEVICE, THERE WAS NO IRREGULARITY FOUND. THE EXACT CAUSE OF THE REPORTED PHENOMENON COULD NOT BE CONCLUSIVELY DETERMINED. HOWEVER, BASED ON THE INFORMATION PROVIDED BY OAZ, OMSC SURMISED THAT THE IMAGE WAS NOT DISPLAYED INTERMITTENTLY DUE TO A COMMUNICATION FAILURE IN THE VIDEO CONNECTOR BECAUSE THE IMAGE DISAPPEARED WHEN THE VIDEO CONNECTOR WAS MOVED. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE SUPPLEMENTED.

    Additional Manufacturer Narrative · 1

    THE SUBJECT DEVICE WAS NOT RETURNED TO OMSC FOR EVALUATION BUT WAS RETURNED TO OLYMPUS (B)(4). OLYMPUS (B)(4) CHECKED THE SUBJECT DEVICE AND FOUND THAT THE REPORTED PHENOMENON WAS DUPLICATED. THE IMAGE DISAPPEARED WHEN VIDEO CONNECTOR WAS MOVED. THE EXACT CAUSE OF THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED AT THIS TIME. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE SUPPLEMENTED.

    Description of Event or Problem · 1

    OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) WAS INFORMED BY THE USER THAT DURING THE UNSPECIFIED PROCEDURE, THE ENDOSCOPIC IMAGE OF THE SUBJECT DEVICE WAS NOT DISPLAYED INTERMITTENTLY. THERE WAS NO REPORT OF PATIENT INJURY ASSOCIATED WITH THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1452311 HD 3CMOS AUTOCLAVABLE CAMERA HEAD AUTOCLAVABLE CAMERA HEAD OWN OLYMPUS MEDICAL SYSTEMS CORP. CH-S200-XZ-EA

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown