BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HD AUTOCLAVABLE CAMERA HEAD

    MDR report key: 10440932 · Received August 24, 2020

    Report

    Report Number
    8010047-2020-05748
    Event Type
    Malfunction
    Date Received
    August 24, 2020
    Date of Event
    July 27, 2020
    Report Date
    October 5, 2020
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    FET
    PMA / PMN Number
    K102059
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE ADDITIONAL INFORMATION. OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) COULD NOT INVESTIGATE THE DEVICE, BECAUSE THE DEVICE WAS NOT RETURNED TO OMSC. OMSC REVIEWED THE MANUFACTURING HISTORY (DHR) OF THE DEVICE AND CONFIRMED NO IRREGULARITY. ON-SITE INVESTIGATION BY OLYMPUS ENGINEER CONFIRMED THE FOLLOWING. -THE REPORTED PHENOMENON WAS NOT REPRODUCED. - THERE WAS A FAILURE IN THE VIDEO CONNECTOR SOCKET ON THE USER'S CV-190. SINCE THE DEVICE WAS NOT RETURNED, THE EXACT CAUSE WAS UNKNOWN; HOWEVER, OMSC ASSUMED THAT THE CV-190'S DAMAGE CONTRIBUTED TO THE REPORTED EVENT.

    Additional Manufacturer Narrative · 1

    THE SUBJECT DEVICE HAS NOT RETURNED TO OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) FOR EVALUATION. THERE WERE NO FURTHER DETAILS PROVIDED. IF SIGNIFICANT ADDITIONAL INFORMATION IS RECEIVED, THIS REPORT WILL BE SUPPLEMENTED.

    Description of Event or Problem · 1

    DURING A LAPAROSCOPIC KEYHOLE SURGERY WITH THE CV-190 AND THE CH-S190-XZ-E, SCOPE COMMUNICATION ERROR E216 APPEARED ON THE MONITOR AND ENDOSCOPIC IMAGE DISAPPEARED. AFTER THE USER REBOOTED THE TWO DEVICES, THEY WORKED PROPERLY. THE USER COMPLETED THE PROCEDURE BY USING THE TWO PRODUCTS. THIS IS A REPORT FOR CH-S190-XZ-E.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    905968 HD AUTOCLAVABLE CAMERA HEAD AUTOCLAVABLE CAMERA HEAD FET OLYMPUS MEDICAL SYSTEMS CORP. CH-S190-XZ-E

    Patients

    Seq Age Sex Outcome Treatment
    1