BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VASOVIEW HEMOPRO ENDOSCOPIC VESSEL HARVESTING SYSTEM

    MDR report key: 1232751 · Received November 14, 2008

    Report

    Report Number
    2953148-2008-00920
    Event Type
    Malfunction
    Date Received
    November 14, 2008
    Date of Event
    November 6, 2008
    Report Date
    November 7, 2008
    Manufacturer
    GUIDANT CARDIAC SURGERY
    Product Code
    GEI
    PMA / PMN Number
    K052274
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AFTER THE PROCEDURE, THE HOSPITAL DISCARDED THE PRODUCT. A LOT HISTORY RECORD REVIEW CANNOT BE PERFORMED BECAUSE THE LOT NUMBER WAS PROVIDED BY THE HOSPITAL.

    Description of Event or Problem · 1

    THE HOSPITAL REPORTED THAT DURING AN ENDOSCOPIC VEIN HARVESTING PROCEDURE, THE HEMOPRO TISSUE WELDER STICKING INSIDE THE CANNULA WHILE TAKING THE VEIN. THEY LUBRICATED THE SHAFT AND USED THE SAME DEVICE TO COMPLETE THE PROCEDURE. THE HOSPITAL DID NOT REPORT ANY PATIENT COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VASOVIEW HEMOPRO ENDOSCOPIC VESSEL HARVESTING SYSTEM GEI GUIDANT CARDIAC SURGERY VH-3000 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 NA