BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VASOVIEW 7XS ENDOSCOPIC VESSEL HARVESTING SYSTEM

    MDR report key: 1257226 · Received December 8, 2008

    Report

    Report Number
    2953148-2008-00973
    Event Type
    Injury
    Date Received
    December 8, 2008
    Report Date
    December 2, 2008
    Manufacturer
    GUIDANT CARDIAC SURGERY
    Product Code
    GCJ
    PMA / PMN Number
    K030512
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE HOSP REPORTED THAT DURING THE ENDOSCOPIC VEIN HARVESTING PROCEDURE, THE HARVESTER OBSERVED SHAVINGS AT THE INCISION SITE WHEN HE REMOVED THE SHORT PORT BLUNT TIP TROCAR (BBT). IT IS NOT KNOWN WHERE THE SHAVINGS CAME FROM. THEY REMOVED THE SHAVINGS FROM THE INCISION SITE. THE SAME BTT PORT WAS USED TO COMPLETE THE PROCEDURE. THE HOSP DID NOT REPORT ANY PT COMPLICATIONS AS A RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VASOVIEW 7XS ENDOSCOPIC VESSEL HARVESTING SYSTEM GCJ GUIDANT CARDIAC SURGERY VH-3100 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Required Intervention