BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TERUMO VIRTUOSAPH VEIN HARVESTING SYSTEM

    MDR report key: 2142108 · Received May 26, 2011

    Report

    Report Number
    1124841-2011-00231
    Event Type
    Malfunction
    Date Received
    May 26, 2011
    Date of Event
    May 10, 2011
    Report Date
    May 11, 2011
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORP.
    Product Code
    GCJ
    PMA / PMN Number
    K031891
    Removal / Correction Number
    NA
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    TERUMO DID RECEIVE THE ACTUAL DEVICE AND VISUAL INSPECTION CONFIRMED THAT THE ENDOSCOPE LENS WAS CRACKED. 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). 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 PRIOR TO VEIN HARVESTING PROCEDURE, DURING SET-UP, THE LENS ON THE ENDOSCOPE WAS CRACKED. THE PRODUCT WAS CHANGED OUT. THERE WAS NO DELAY IN BEGINNING OF SURGERY. 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. MCENDO550 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK