BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VASOVIEW HEMOPRO ENDOSCOPIC VESSEL HARVESTING SYSTEM

    MDR report key: 1502560 · Received September 16, 2009

    Report

    Report Number
    3006262933-2009-01042
    Event Type
    Malfunction
    Date Received
    September 16, 2009
    Report Date
    August 25, 2009
    Manufacturer
    MAQUET CARDIOVASCULAR
    Product Code
    GEI
    PMA / PMN Number
    K052274
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION DETAILS: MAQUET RECEIVED THE PRODUCT FOR INVESTIGATION AND QAT VISUAL INSPECTION SHOWED THAT THE COLD JAW BOOT INSULATION CRACKED. MAQUET QE IS PERFORMING FURTHER INVESTIGATION. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION HAS BEEN COMPLETED. (B) (4).

    Description of Event or Problem · 1

    THE HOSPITAL REPORTED THAT DURING THE PREPARATION FOR AN ENDOSCOPIC VEIN HARVESTING PROCEDURE, THE OR STAFF FOUND THAT THE SILICONE COATING ON THE HEMOPRO'S JAW IS DEFECTIVE OUT OF THE BOX. THE COATING WAS SPLIT, NOT INTACT. A REPLACEMENT DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PT COMPLICATION REPORTED BY THE HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VASOVIEW HEMOPRO ENDOSCOPIC VESSEL HARVESTING SYSTEM GEI MAQUET CARDIOVASCULAR VH-3000 81218R1

    Patients

    Seq Age Sex Outcome Treatment
    1 NA