BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VASOVIEW HEMOPRO EVH SYSTEM

    MDR report key: 2180766 · Received April 29, 2011

    Report

    Report Number
    2242352-2011-00486
    Event Type
    Malfunction
    Date Received
    April 29, 2011
    Date of Event
    April 1, 2011
    Report Date
    April 4, 2011
    Manufacturer
    MAQUET CARDIOVASCULAR, LLC
    Product Code
    GEI
    PMA / PMN Number
    K052274
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: THE DEVICE HAS NOT BEEN RETURNED TO MAQUET CARDIOVASCULAR FOR INVESTIGATION. WE WILL CONTINUE PURSUING THE DEVICE BEING RETURNED BY THE CUSTOMER. A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF THE DEVICE IS RECEIVED AND THE INVESTIGATION IS COMPLETED. A LOT HISTORY RECORD REVIEW WAS COMPLETED FOR THE PRODUCT. THERE WAS NO NONCONFORMANCE WHICH COULD HAVE CONTRIBUTED TO THIS FAILURE MODE. (B)(4).

    Description of Event or Problem · 1

    THE HOSPITAL REPORTED AFTER AN ENDOSCOPIC VEIN HARVESTING PROCEDURE WAS COMPLETED, THE PA NOTICED THAT THE VH-3000 JAWS APPEARED TO BE SCRAPED. THE HOSPITAL DID NOT REPORT ANY PATIENT EFFECTS. IT IS UNKNOWN IF THE PRODUCT IS RETURNING. THE TM MENTIONED THAT THE PA MAY HAVE INSERTED/TAKEN OUT THE HEMOPRO WITH THE JAWS OPENED AND HE ALSO DIDN'T PUT THE SCOPE IN FIRST BEFORE THE HEMOPRO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VASOVIEW HEMOPRO EVH SYSTEM ENDOSCOPIC VESSEL HARVESTING SYSTEM GEI MAQUET CARDIOVASCULAR, LLC VH-3000 25024769

    Patients

    Seq Age Sex Outcome Treatment
    1 NA