BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VASOVIEW HEMOPRO EVH TISSUE WELDER

    MDR report key: 1587770 · Received January 15, 2010

    Report

    Report Number
    2242352-2009-00086
    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 DEVICE IN THIS COMPLAINT ARE REPORTED IN (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 POWER WAS ON AND THE DEVICE WAS PLACED UNDER A TOWEL IN THE STERILE FIELD. UPON NOTICING SMOKE FROM THE TOWEL, THE DEVICE WAS PICKED UP AND THE JAWS WERE RED-HOT AND SMOKING. THE CABLE HAD NOT BEEN PRE-TESTED. TWO MORE HEMOPRO KITS WERE OPENED, BOTH WITH SIMILAR PROBLEMS. A FOURTH HEMOPRO AND 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