BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HD 3CMOS AUTOCLAVABLE CAMERA HEAD

    MDR report key: 11522964 · Received March 19, 2021

    Report

    Report Number
    8010047-2021-03954
    Event Type
    Malfunction
    Date Received
    March 19, 2021
    Date of Event
    February 23, 2021
    Report Date
    April 15, 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

    Narratives

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE ADDITIONAL INFORMATION. THE DEVICE WAS RETURNED TO THE OLYMPUS LOCAL SERVICE DEPARTMENT. THE OLYMPUS LOCAL SERVICE DEPARTMENT CHECKED THE DEVICE AND FOUND THAT THE REPORTED PHENOMENON WAS DUPLICATED AND THE CABLE UNIT OF THE DEVICE WAS BROKEN. OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) COULD NOT INVESTIGATE THE DEVICE, BECAUSE THE DEVICE WAS NOT RETURNED TO OMSC. DEVICE HISTORY RECORD REVIEW INDICATES THAT THE PRODUCT WAS MANUFACTURED AND TESTED IN ACCORDANCE WITH ALL APPLICABLE PROCEDURES AND MET ALL FINAL PRODUCT RELEASE CRITERIA. THE ROOT CAUSE HAS NOT BEEN CONCLUSIVELY DETERMINED. BASED ON EVALUATION, OMSC SURMISED THAT THE REPORTED PHENOMENON WAS OCCURRED DUE TO THE CABLE UNIT OF THE DEVICE WAS BROKEN BY EXCESSIVE STRESS.

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED TO OLYMPUS (B)(4). THE DEVICE HAS NOT RETURNED TO OLYMPUS MEDICAL SYSTEMS CORPORATION. (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

    OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) WAS INFORMED FROM THE USER THAT DURING THE PREPARATION FOR USE, FUZZY, GREY ENDOSCOPIC IMAGE APPEARED ON THE MONITOR. OTHER DETAILED INFORMATION WAS NOT PROVIDED. THERE WAS NO REPORT OF PATIENT INJURY ASSOCIATED WITH THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    424870 HD 3CMOS AUTOCLAVABLE CAMERA HEAD AUTOCLAVABLE CAMERA HEAD OWN OLYMPUS MEDICAL SYSTEMS CORP. CH-S200-XZ-EA

    Patients

    Seq Age Sex Outcome Treatment
    1