BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    4K CAMERA HEAD

    MDR report key: 11730204 · Received April 27, 2021

    Report

    Report Number
    8010047-2021-05445
    Event Type
    Malfunction
    Date Received
    April 27, 2021
    Date of Event
    April 2, 2021
    Report Date
    June 17, 2021
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    FET
    PMA / PMN Number
    K172817
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE ADDITIONAL INFORMATION. THE DEVICE HAS NOT BEEN RETURNED TO OLYMPUS MEDICAL SYSTEMS CORP.(OMSC) BUT WAS RETURNED TO THE SERVICE DEPARTMENT OF OLYMPUS (THAILAND) CO., LTD. (OTH) FOR EVALUATION. OTH INSPECTED THE DEVICE AND CONFIRMED THE FOLLOWING: THE REPORTED PHENOMENON WAS REPRODUCED. THE CABLE UNIT WAS DEFORMED. BASED ON THE DEVICE INSPECTION RESULT BY OTH, IT IS POSSIBLE THAT THE ENDOSCOPIC IMAGE WAS NOT DISPLAYED BECAUSE THE VIDEO COMMUNICATION COULD NOT BE TRANSMITTED TO THE VIDEO SYSTEM CENTER DUE TO THE DAMAGE OF THE CAMERA CABLE. OMSC CHECKED THE SHIPPING RECORD OF THE DEVICE, BUT THERE WAS NO ABNORMALITY ON THE DEVICE. THE INSTRUCTION MANUAL PROVIDES PREVENTIVE MEASURES AGAINST REPORTED CAMERA CABLE BREAKAGE. DEVICE HISTORY RECORD (DHR) REVIEW INDICATES THAT THE PRODUCT WAS MANUFACTURED AND TESTED IN ACCORDANCE WITH ALL APPLICABLE PROCEDURES AND MET ALL FINAL PRODUCT RELEASE CRITERIA. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE SUPPLEMENTED.

    Additional Manufacturer Narrative · 1

    AN OLYMPUS ENGINEER VISITED THE USER FACILITY AND CONFIRMED THAT THE REPORTED EVENT WAS REPRODUCED. THE DEVICE HAS BEEN RETURNED TO THE SERVICE DEPARTMENT OF OLYMPUS (B)(4) CO., LTD. FOR INSPECTION. THE EXACT CAUSE OF THE REPORTED EVENT HAS NOT YET BEEN IDENTIFIED BY LEGAL MANUFACTURER OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) FOR THIS DEVICE. IF SIGNIFICANT ADDITIONAL INFORMATION IS RECEIVED, THIS REPORT WILL BE SUPPLEMENTED.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED ON THE PHONE THAT THE ENDOSCOPIC IMAGE WAS NOT DISPLAYED DURING PREPARATION FOR USE. THERE WAS NO REPORT OF PATIENT INJURY ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    631566 4K CAMERA HEAD CAMERA HEAD FET OLYMPUS MEDICAL SYSTEMS CORP. CH-S400-XZ-EB

    Patients

    Seq Age Sex Outcome Treatment
    1