BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VASOVIEW HEMOPRO ENDOSCOPIC VESSEL HARVESTING SYSTEM

    MDR report key: 1133742 · Received August 20, 2008

    Report

    Report Number
    2953148-2008-00737
    Event Type
    Malfunction
    Date Received
    August 20, 2008
    Report Date
    August 12, 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
    WI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION RESULTS: THE DEVICE WAS RECEIVED WITH THE C-RING SPLIT (BROKE) IN HALF AND STILL ATTACHED TO THE C-RING SLIDER WIRE. THE BROKEN C-RING HALF WHICH IS NORMALLY ATTACHED TO THE SCOPE WASH TUBING WAS NOT RETURNED WITH DEVICE. A VISUAL INSPECTION FOUND THAT THE C-RING WAS SUBJECTED TO A HEAT SOURCE LONG ENOUGH TO MELT AND SUBSEQUENTLY SPLIT THE C-RING INTO TWO PIECES DURING CLINICAL MANIPULATION. THE MOST LIKELY CAUSE OF THE C-RING BREAKING IN HALF IS THAT IT CAME IN CONTACT WITH THE HEMOPRO HOT JAW WHILE THE JAW WAS ENERGIZED. THE REPORTED COMPLAINT FOR C-RING BROKE IS CONFIRMED. A LOT HISTORY RECORD REVIEW WAS COMPLETED FOR THE PRODUCT. THERE WAS NO NONCONFORMANCE WHICH COULD HAVE ATTRIBUTED TO THIS FAILURE MODE.

    Description of Event or Problem · 1

    THE HOSPITAL REPORTED THAT DURING THE ENDOSCOPIC VEIN HARVESTING PROCEDURE, THE HEMOPRO C-RING BROKE. A REPLACEMENT UNIT WAS USED TO COMPLETE THE PROCEDURE. THE HOSPITAL DID NOT REPORT ANY PATIENT COMPLICATIONS. WHEN THE MAQUET SALES REP PICKED UP THE DEVICE FROM THE HOSPITAL, HE OBSERVED THAT HALF OF THE C-RING WAS MISSING AND THE OTHER HALF WAS STILL ATTACHED TO THE C-RING SLIDER WIRE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VASOVIEW HEMOPRO ENDOSCOPIC VESSEL HARVESTING SYSTEM GEI GUIDANT CARDIAC SURGERY VH-3000 8070772

    Patients

    Seq Age Sex Outcome Treatment
    1 NA