BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DISSECTION TIP

    MDR report key: 1213758 · Received October 22, 2008

    Report

    Report Number
    2953148-2008-00864
    Event Type
    Malfunction
    Date Received
    October 22, 2008
    Date of Event
    September 30, 2008
    Report Date
    October 1, 2008
    Manufacturer
    GUIDANT CARDIAC SURGERY
    Product Code
    GEI
    PMA / PMN Number
    K020143
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION RESULTS: THE VISUAL INSPECTION OBSERVED THAT THE DISSECTION TIP HAD A NON-CLEAR AREA ON THE OUTSIDE SURFACE. THIS NON-CLEAR AREA HAD A FROSTED APPEARANCE ON THE PLASTIC. A CLEAR DEPOSIT WAS ALSO PRESENT INSIDE THE DISSECTION TIP AREA. THE DISSECTION TIP WAS COMPARED AGAINST A REFERENCE TIP AND THE IMAGES WERE NOT COMPARABLE. THE RETURNED LENS IMAGE APPEARED TO BE CLOUDY, AS REPORTED BY THE HOSPITAL. 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 AN ENDOSCOPIC VEIN HARVESTING PROCEDURE, THE CONICAL DISSECTION TIP WAS CLOUDY. A REPLACEMENT UNIT WAS USED TO COMPLETE THE PROCEDURE. THE HOSPITAL DID NOT REPORT ANY PT COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DISSECTION TIP GEI GUIDANT CARDIAC SURGERY VH-1114 8040971

    Patients

    Seq Age Sex Outcome Treatment
    1 NA