BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HD AUTOCLAVABLE CAMERA HEAD

    MDR report key: 10354562 · Received August 3, 2020

    Report

    Report Number
    8010047-2020-05145
    Event Type
    Malfunction
    Date Received
    August 3, 2020
    Date of Event
    June 26, 2020
    Report Date
    November 12, 2020
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    FET
    PMA / PMN Number
    K955404
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER

    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. 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. SINCE THE DEVICE WAS NOT RETURNED, THE EXACT CAUSE WAS UNKNOWN. OLYMPUS LOCAL SERVICE ENGINEER REPORT THAT THE CABLE UNIT OF THE DEVICE WAS BROKEN. OMSC SURMISED THAT THE REPORTED PHENOMENON WAS OCCURRED DUE TO THE CABLE UNIT WAS BROKEN (DISCONNECTED) BY EXCESSIVE STRESS. THE INSTRUCTION MANUAL OF THE DEVICE STATES THE CORRESPONDING METHOD IN CASE OF AN ABNORMALITY.

    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

    OLYMPUS SERVICE OPERATION REPAIR CENTER WAS INFORMED FROM THE FACILITY THAT IN UNSPECIFIED TIMING THE SUBJECT DEVICE DID NOT WORK. OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) WAS INFORMED THAT DURING THE INCOMING INSPECTION FOR REPAIR AT OLYMPUS SERVICE OPERATION REPAIR CENTER, IT WAS FOUND THAT AN ENDOSCOPIC IMAGE WAS FLICKERING 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
    820182 HD AUTOCLAVABLE CAMERA HEAD CAMERA HEAD FET OLYMPUS MEDICAL SYSTEMS CORP. OTV-S7PROH-HD-10E

    Patients

    Seq Age Sex Outcome Treatment
    1