BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VASOVIEW HEMOPRO ENDOSCOPIC VESSEL HARVESTING SYSTEM

    MDR report key: 1232753 · Received November 14, 2008

    Report

    Report Number
    2953148-2008-00914
    Event Type
    Malfunction
    Date Received
    November 14, 2008
    Date of Event
    September 23, 2008
    Report Date
    October 28, 2008
    Manufacturer
    GUIDANT CARIDAC SURGERY
    Product Code
    GEI
    PMA / PMN Number
    K052274
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION RESULTS: THE VISUAL INSPECTION SHOWED THAT THE COLD JAW BOOT INSULATION HAD MULTIPLE CRACKS. BOTH THE HOT ELEMENT AND COLD BOOT APPEARED TO BE UNUSED. THE REPORTED FAILURE WAS CONFIRMED. A LOT HISTORY RECORD REVIEW WAS COMPLETED FOR THE PRODUCT AND THERE WAS NO NONCONFORMANCE ASSOCIATED WITH THE LOT NUMBER.

    Description of Event or Problem · 1

    THE HOSPITAL REPORTED THAT DURING PREPARATION FOR AN ENDOSCOPIC VEIN HARVESTING PROCEDURE, WHILE UNPACKING THE DEVICE, STAFF OBSERVED THE HEMOPRO JAW BOOT COATING WAS SHREDDED ON THE TIP. A REPLACEMENT UNIT WAS USED 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 CARIDAC SURGERY VH-3000 8081171

    Patients

    Seq Age Sex Outcome Treatment
    1 NA