BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TERUMO VIRTUOSAPH VEIN HARVESTING SYSTEM

    MDR report key: 2150614 · Received June 22, 2011

    Report

    Report Number
    1124841-2011-00270
    Event Type
    Malfunction
    Date Received
    June 22, 2011
    Date of Event
    June 6, 2011
    Report Date
    June 6, 2011
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORP.
    Product Code
    GCJ
    PMA / PMN Number
    K031891
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    TERUMO DID RECEIVE THE ACTUAL DEVICE; VISUAL INSPECTION NOTED MINOR SCRATCHES, DENTS ON THE ROD AND EYEPIECE OF THE ENDOSCOPE. THIS TYPE OF DAMAGE IS OFTEN ATTRIBUTED TO HANDLING ISSUES. THE DEVICE IFU STATES THAT THE ENDOSCOPE MUST BE HANDLED WITH EXTREME CARE TO PREVENT DAMAGE TO THE DEVICE. (B)(4). THE DEVICE IFU STATES TO CHECK THE IMAGE QUALITY BEFORE AND AFTER EACH USE TO CHECK FOR SIGNS OF DAMAGE. IF IMAGE IS UNACCEPTABLE, CONTACT TERUMO CVS CUSTOMER SERVICE FOR ASSISTANCE. ALL AVAILABLE INFORMATION HAS BEEN PLACED ON FILE IN QUALITY MANAGEMENT FOR APPROPRIATE TRACKING, TRENDING AND FOLLOW UP.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR SYSTEMS THAT DURING VEIN HARVESTING PROCEDURE, THE ENDOSCOPE WAS CLOUDY. THE PRODUCT WAS CHANGED OUT. THERE WAS NO HARM TO THE PATIENT. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TERUMO VIRTUOSAPH VEIN HARVESTING SYSTEM ENDOSCOPE GCJ TERUMO CARDIOVASCULAR SYSTEMS CORP. MCENDO550R NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK