BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VISERA LAPARO-THORACO VIDEOSCOPE

    MDR report key: 7258535 · Received February 9, 2018

    Report

    Report Number
    8010047-2018-00189
    Event Type
    Malfunction
    Date Received
    February 9, 2018
    Date of Event
    January 11, 2018
    Report Date
    July 11, 2018
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    GCJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO ADDITIONAL EVALUATION RESULT OF THE SUBJECT DEVICE. THE ADDITIONAL EVALUATION BY OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) CONFIRMED FOLLOWING. THE ANALYSIS (FOURIER TRANSFORM INFRARED SPECTROMETER) INDICATED THAT THE FOREIGN MATERIAL, WHICH FELL ON THE FEMORAL REGION, WAS IDENTICAL TO THE INSERTION TUBE POSITION ALIGNMENT DOTS (COATING). THE SIZE OF THE FOREIGN MATERIAL WAS SAME AS THE INSERTION TUBE POSITION ALIGNMENT DOTS (COATING).

    Additional Manufacturer Narrative · 1

    THE SUBJECT DEVICE REFERENCED IN THIS REPORT WAS RETURNED TO OMSC FOR EVALUATION. THE EVALUATION CONFIRMED THAT THE INSERTION TUBE POSITION ALIGNMENT DOTS (COATING) PEELED OFF AND THE ADHESIVE GLUE AT THE PROXIMAL END OF THE INSERTION TUBE WAS CRACKED. OMSC REVIEWED THE MANUFACTURE HISTORY OF THE SUBJECT DEVICE WITH NO IRREGULARITY. THE SUBJECT DEVICE HAD BEEN USED FOR APPROXIMATELY 14 YEARS AT THE FACILITY. DETERIORATION DURING THE 14 YEARS USAGE CANNOT BE RULED OUT AS A POSSIBLE CAUSE OF THE EVENT.

    Description of Event or Problem · 1

    OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) WAS INFORMED THAT DURING AN OPEN SURGERY IN UROLOGY USING THE SUBJECT DEVICE AS ASSISTANT LIGHT, THE FACILITY NOTICED A YELLOW FOREIGN MATERIAL (COATING) ON THE FEMORAL REGION OF THE PATIENT AND RETRIEVED IT. THE FACILITY INSPECTED THE SUBJECT DEVICE AND FOUND TWO OF THREE INSERTION TUBE POSITION ALIGNMENT DOTS (COATING) WAS MISSING. THE FACILITY REPORTED THAT THE REST OF MISSING DOTS POSSIBLY FELL OFF WITHIN THE PATIENT SINCE THEY COULD NOT FIND IT. THERE WAS NO PATIENT INJURY REPORTED ASSOCIATED WITH THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    102033 VISERA LAPARO-THORACO VIDEOSCOPE LAPARO-THORACO VIDEOSCOPE GCJ OLYMPUS MEDICAL SYSTEMS CORP. LTF-V3

    Patients

    Seq Age Sex Outcome Treatment
    1