BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OLYMPUS LIGHT GUIDE CABLE

    MDR report key: 2018028 · Received March 8, 2011

    Report

    Report Number
    9610773-2011-00007
    Event Type
    Malfunction
    Date Received
    March 8, 2011
    Date of Event
    November 16, 2010
    Report Date
    February 10, 2011
    Manufacturer
    OLYMPUS WINTER & IBE GMBH
    Product Code
    KOG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    OLYMPUS FOLLOWED UP WITH THE USER FACILITY TO OBTAIN ADD'L INFO REGARDING THE REPORT, AND WAS INFORMED THAT DURING AN ENDOSCOPIC VEIN HARVESTING PROCEDURE, THE LIGHT CORD BROKE. THE PROCEDURE WAS THEN COMPLETED USING A DIFFERENT LIGHT CORD. THE SUBJECT LIGHT CORD WAS NOT RETURNED TO OLYMPUS FOR EVAL, AS IT WAS DISCARDED AFTER THE USER FACILITY RECEIVED A REPLACEMENT CORD. THERE WAS NO PT INJURY REPORTED. THE EXACT CAUSE OF THE USER'S EXPERIENCE COULD NOT BE CONCLUSIVELY DETERMINED. THIS REPORT IS BEING SUBMITTED AS A MEDICAL DEVICE REPORT (MDR) IN AN ABUNDANCE OF CAUTION. OLYMPUS AMERICA INC IS FILING MDRS ON BEHALF OF (B)(4) AND OLYMPUS MEDICAL SYSTEMS CORP. PLEASE (B)(4).

    Description of Event or Problem · 1

    OLYMPUS RECEIVED A MEDWATCH THAT STATED, "DURING THE ENDOSCOPIC VEIN HARVEST, THE LIGHT CORD ATTACHED TO CAMERA AND VASOVIEW BROKE. NO INJURY TO PT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OLYMPUS LIGHT GUIDE CABLE LIGHT GUIDE CABLE KOG OLYMPUS WINTER & IBE GMBH WA03210A NA

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR