BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GUIDANT VASOVIEW 5 DISSECTION TIP

    MDR report key: 701335 · Received June 30, 2005

    Report

    Report Number
    2953148-2005-00510
    Event Type
    Malfunction
    Date Received
    June 30, 2005
    Date of Event
    June 7, 2005
    Report Date
    June 7, 2005
    Manufacturer
    GUIDANT CARDIAC SURGERY
    Product Code
    GEI
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE HOSPITAL REPORTED THAT PRIOR TO AN ENDOSCOPIC SAPHENOUS VEIN HARVESTING PROCEDURE, THE SHAFT OF THE DEVICE WAS BROKEN. IT WAS REPORTED THAT THE "PIECE WAS BROKEN" PRIOR TO OPENING THE PACKAGE AND THE DEVICE WAS NOT USED ON THE PATIENT. UPON RECEIPT OF THE DEVICE ON JUNE 21, 2005, IT WAS IDENTIFIED THAT THE NOSE CONE OF THE DISSECTION TIP HAD BROKEN OFF. THIS IS A REPORTABLE MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GUIDANT VASOVIEW 5 DISSECTION TIP ENDOSCOPE AND ACCESSORIES GEI GUIDANT CARDIAC SURGERY VH-1114 5041172

    Patients

    Seq Age Sex Outcome Treatment
    1 NA