BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HD 3CMOS CAMERA HEAD

    MDR report key: 12932595 · Received December 6, 2021

    Report

    Report Number
    8010047-2021-15571
    Event Type
    Malfunction
    Date Received
    December 6, 2021
    Date of Event
    November 8, 2021
    Report Date
    February 27, 2022
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    OWN
    PMA / PMN Number
    K200542
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    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 MEDICAL SYSTEMS INDIA PRIVATE LIMITED (OMSI). OMSC CHECKED THE DEVICE HISTORY RECORD OF THE SUBJECT DEVICE, THERE WAS NO IRREGULARITY FOUND. THE EXACT CAUSE OF THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED. ERROR CODE E216 MEANS THAT THE COMMUNICATION BETWEEN THE CAMERA HEAD AND VIDEO SYSTEM CENTER HAS FAILED. BASED ON THE INFORMATION PROVIDED BY OMSI, OMSC SURMISED THAT THE REPORTED PHENOMENON MIGHT HAVE OCCURRED BY COMMUNICATION FAILURE BETWEEN THE SUBJECT DEVICE AND THE VIDEO PROCESSOR DUE TO THE DEFECTIVE OF THE CABLE UNIT, AND ALSO SURMISED THAT THE CABLE UNIT DEFECTIVE WAS CAUSED BY CABLE TWISTING. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE SUPPLEMENTED.

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS RETURNED TO OLYMPUS MEDICAL SYSTEMS (B)(4) PRIVATE LIMITED (OMSI) FOR EVALUATION. OMSI CHECKED THE SUBJECT DEVICE AND FOUND THE REPORTED PHENOMENON. AS A RESULT OF THE EVALUATION, THE FOLLOWING WAS CONFIRMED. THE SCOPE COMMUNICATION ERROR E216 HAS OCCURRED DUE TO A CAMERA CABLE UNIT FAILURE. THE CAMERA CABLE WAS KINKED AND TWISTED. THE VIDEO PLUG UNIT WAS CRACKED. 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 · 0

    OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) WAS INFORMED BY THE USER THAT DURING UNSPECIFIED TIMING, THE USER CHECKED THE SUBJECT DEVICE AND FOUND THAT THE SCOPE COMMUNICATION ERROR E216 WAS DISPLAYED ON THE MONITOR. THE USER CLEANED THE VIDEO CONNECTOR, HOWEVER THE ERROR E216 STILL OCCURRED. THERE WAS NO REPORT OF PATIENT INJURY ASSOCIATED WITH THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1832294 HD 3CMOS CAMERA HEAD CAMERA HEAD OWN OLYMPUS MEDICAL SYSTEMS CORP. CH-S200-XZ-EB

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown