BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HD CAMERA HEAD

    MDR report key: 4845331 · Received June 11, 2015

    Report

    Report Number
    8010047-2015-00506
    Event Type
    Malfunction
    Date Received
    June 11, 2015
    Date of Event
    April 13, 2015
    Report Date
    May 29, 2015
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE REFERENCED DEVICE WAS RETURNED TO OLYMPIC MEDICAL SYSTEMS CORP. (OMSC) FOR EVAL. OMSC EVALUATED THE DEVICE AND FOUND THAT THE ENDOSCOPIC IMAGE WAS DISPLAYED BUT THE CABLE OF THE DEVICE WAS KINKED. ALSO THE NOISE OCCURRED ON THE IMAGE WITH MOVING THE CABLE OF THE DEVICE. IT WAS CONSIDERED THAT THE CONDUCTING WIRES INSIDE THE CABLE WERE ALMOST BREAKING. ACCORDING TO THER REPORT FROM THE FACILITY, THE PHYSICIAN PASSED THE NURSE THE DEVICE WITH ONLY HOLDING THE CABLE OF THE DEVICE. CONSEQUENTLY THE CABLE OF THE DEVICE WAS SHOCKED AND THEN DAMAGED. OLYMPUS ATTRIBUTED THIS PHENOMENON TO INAPPROPRIATE HANDLING OF THE DEVICE BY THE USER. THE OTV-S7-PROH-HD-L08E INSTRUCTION MANUAL STATES THE NOTICE FOR THE HANDLING OF THE DEVICE. ALSO OMSC CHECKED THE MANUFACTURE HISTORY OF THE SUBJECT DEVICE, THERE WAS NO IRREGULARITY FOUND. THERE WERE NO FURTHER DETAILS PROVIDED. IF SIGNIFICANT ADDITIONAL INFO IS RECEIVED, THIS REPORT WILL BE SUPPLEMENTED. THIS REPORT IS BEING SUBMITTED AS A MEDICAL DEVICE REPORT IN AN ABUNDANCE OF CAUTION.

    Description of Event or Problem · 1

    OLYMPUS WAS INFORMED THAT DURING THE TUR PROCEDURE, THE ENDOSCOPIC IMAGE MOMENTARILY DISAPPEARED AND/OR THE NOISE OCCURRED ON THE IMAGE. THE FACILITY CHANGED THE CAMERA HEAD TO THE SIMILAR BUT OTHER DEVICE AND THE PHYSICIAN COMPLETED THE PROCEDURE. ON (B)(6) 2015, OLYMPUS WAS INFORMED THAT THE DEVICE HAD BEEN EXCHANGED DURING THE PROCEDURE. THERE WAS NO REPORT OF THE PATIENT'S INJURY REGARDING THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    380801 HD CAMERA HEAD CAMERA HEAD GEI OLYMPUS MEDICAL SYSTEMS CORP. OTV-S7PROH-HD-L08E

    Patients

    Seq Age Sex Outcome Treatment
    1