BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OLYMPUS VIDEO TELESCOPE

    MDR report key: 1873367 · Received October 13, 2010

    Report

    Report Number
    9610773-2010-00038
    Event Type
    Malfunction
    Date Received
    October 13, 2010
    Date of Event
    August 19, 2010
    Report Date
    September 14, 2010
    Manufacturer
    OLYMPUS MEDICAL SYSTEM CORP
    Product Code
    GCJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    OLYMPUS FOLLOWED UP WITH THE USER FACILITY VIA TELEPHONE AND IN WRITING TO OBTAIN ADDITIONAL INFORMATION REGARDING THE REPORT, AND WAS INFORMED THAT SEVERAL OF THE STAFF PRESENT AT THE TIME OF THE PROCEDURE DID NOT OBSERVE ANY ANOMALIES WITH THE IMAGE. THE STAFF FURTHER REPORTED THAT THE PROCEDURE WAS CONVERTED TO AN OPEN SURGERY DUE TO THE SIZE OF THE GALLSTONE, WHICH WAS TOO LARGE TO BE REMOVED THROUGH LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE, AND NOT DUE TO A DEVICE MALFUNCTION. AN OLYMPUS REPRESENTATIVE HAD VISITED THE FACILITY TO EVALUATE THE TELESCOPE AND MONITORS THE DAY AFTER THE EVENT DUE TO THE USER'S REPORT OF "BAD SCOPE DURING A PROCEDURE." THE REPRESENTATIVE EXAMINED THE IMAGE WITH THE HOSPITAL BIOMEDICAL ENGINEER, AND NO ANOMALIES WERE OBSERVED ON THE EQUIPMENT. THE STAFF AT USER FACILITY REPORTED THAT ALL EQUIPMENT WERE RETURNED TO CIRCULATION AFTER THE TESTING PERFORMED BY THE CLINICAL ENGINEER AND THE OLYMPUS REPRESENTATIVE, AND THERE WAS NO FURTHER ISSUE REPORTED SINCE THEN. THE WHEREABOUTS OF THE SUBJECT DEVICE ARE CURRENTLY UNK WITHIN THE USER FACILITY, AND THE CAUSE OF THE USER'S EXPERIENCE COULD NOT BE DETERMINED AT THIS TIME. OLYMPUS WILL CONTINUE TO WORK WITH THE USER FACILITY TO GATHER ADDITIONAL INFORMATION REGARDING THE REPORT; IF ADDITIONAL AND SIGNIFICANT INFORMATION BECOMES AVAILABLE LATER, THIS REPORT WILL BE UPDATED. THIS REPORT IS BEING SUBMITTED AS A MEDICAL DEVICE REPORT IN ABUNDANCE OF CAUTION.

    Description of Event or Problem · 1

    OLYMPUS RECEIVED A MEDWATCH REPORT, WHICH STATED: "DURING THE PROCEDURE, THE SURGEON BELIEVED THE PICTURE ON THE MONITOR WAS "FUZZY, UNCLEAR, AND COLOR OFF". THE RESIDENT ALSO FELT THE PICTURE WAS UNCLEAR. THE TECH AND CIRCULATOR THOUGHT THE PICTURE LOOKED OK TO THEM. DESPITE THE STAFF'S OPINION, THE SURGEON PROCEEDED WITH A CONVERSION TO AN OPEN PROCEDURE AND THE EQUIPMENT-CAMERA AND LIGHT CORD WERE PULLED OUT OF SERVICE FOR INSPECTION. THERE WAS NO PT INJURY REPORTED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OLYMPUS VIDEO TELESCOPE TELESCOPE GCJ OLYMPUS MEDICAL SYSTEM CORP WA50011A NA

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR Other SONY MONITOR: MODEL LMD2450MD, SERIAL # (B)(4)| (SLAVE MONITOR).| SONY MONITOR: MODEL LMD2450MD, SERIAL # (B)(4)