BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OLYMPUS SCOPE CABLE EXERA II

    MDR report key: 2885311 · Received November 20, 2012

    Report

    Report Number
    8010047-2012-00434
    Event Type
    Malfunction
    Date Received
    November 20, 2012
    Report Date
    October 23, 2012
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORPORATION
    Product Code
    KQM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    OLYMPUS FOLLOWED-UP WITH THE USER FACILITY TO OBTAIN ADD'L INFO REGARDING THIS REPORT. THE USER FACILITY REPORTED THAT THERE WAS A COMPLETE LOSS OF IMAGE DURING AN UNSPECIFIED COLONOSCOPY PROCEDURE. THE INTENDED PROCEDURE WAS SAID TO HAVE BEEN COMPLETED WITH A NEW CABLE. THERE WAS NO PT HARM REPORTED. THE DEVICE EVAL DID NOT CONFIRM THE USER'S REPORT. THE REFERENCED DEVICE WAS EVALUATED AND THE IMAGE WAS FOUND FLICKERING WHEN THE CABLE WAS MANIPULATED AT THE ROUND CONNECTOR SIDE. THE REFERENCE DEVICE WAS EVALUATED WITH A (B)(4) CABLE TESTER AND IT PASSED THE CONTINUITY CHECK. THERE WAS AN UNSTABLE CONNECTION INTERNALLY WITH THE WIRES. THE REFERENCED DEVICE HAD BEEN FORWARDED TO THE ORIGINAL EQUIPMENT MFR (OEM) FOR FURTHER EVAL.

    Description of Event or Problem · 1

    OLYMPUS WAS INFORMED THAT THE REFERENCED DEVICE FAILED DURING A PROCEDURE. THERE WAS NO FURTHER DETAIL PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OLYMPUS SCOPE CABLE EXERA II SCOPE CABLE KQM OLYMPUS MEDICAL SYSTEMS CORPORATION MAJ-1430 NA

    Patients

    Seq Age Sex Outcome Treatment
    1