BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VASOVIEW HEMOPRO EVH TISSUE WELDER

    MDR report key: 1587771 · Received January 15, 2010

    Report

    Report Number
    2242352-2009-00094
    Event Type
    Malfunction
    Date Received
    January 15, 2010
    Date of Event
    December 18, 2009
    Report Date
    December 18, 2009
    Manufacturer
    MAQUET CARDIOVASCULAR
    Product Code
    GEI
    PMA / PMN Number
    K052274
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    MAQUET CARDIOVASCULAR RECEIVED THE DEVICE ON 01/04/2009. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION HAS BEEN COMPLETED AND THE FINAL FAILURE ANALYSIS HAS BEEN RECEIVED. NOTE - THE OTHER DEVICES IN THIS COMPLAINT ARE REPORTED IN (B) (4) AND (B) (4). TWO LOT NUMBERS WERE REPORTED FOR THESE THREE COMPLAINTS (2 DEVICES WITH 9081971 AND 1 DEVICE WITH 25001683), BUT THE HOSPITAL DID NOT KNOW WHICH WAS ASSOCIATED WITH EACH DEVICE. (B) (4)

    Description of Event or Problem · 1

    THE HOSPITAL REPORTED THAT DURING PREPARATION FOR AN ENDOSCOPIC VEIN HARVESTING PROCEDURE, THE HEMOPRO TISSUE WELDER TRI-HEATER ASSEMBLY WAS DETACHED AND BENT. TWO OTHER HEMOPRO KITS WERE OPENED WITH PROBLEMS AS WELL. A FOURTH HEMOPRO AND A NEW CABLE WERE USED TO COMPLETE THE PROCEDURE. THE HOSPITAL DID NOT REPORT ANY PT COMPLICATIONS. THE PRODUCTS ARE RETURNING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VASOVIEW HEMOPRO EVH TISSUE WELDER HEMOPRO TISSUE WELDER GEI MAQUET CARDIOVASCULAR VH-3000 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 NA