BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VASOVIEW HEMOPRO TISSUE WELDER

    MDR report key: 2031958 · Received March 16, 2011

    Report

    Report Number
    2242352-2010-00294
    Event Type
    Injury
    Date Received
    March 16, 2011
    Date of Event
    January 14, 2010
    Report Date
    January 14, 2010
    Manufacturer
    MAQUET CARDIOVASCULAR, LLC
    Product Code
    GEI
    PMA / PMN Number
    K052274
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SD, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: THE PRODUCT IS NOT AVAILABLE FOR EVALUATION, THEREFORE, THE DEVICE EVALUATION COULD NOT BE COMPLETED. A LOT HISTORY RECORD REVIEW COULD NOT BE PERFORMED AS THE PRODUCT LOT NUMBER IS UNK. (B)(4).

    Description of Event or Problem · 1

    THE HOSPITAL REPORTED THAT DURING AN ENDOSCOPIC VEIN HARVESTING PROCEDURE, THE VASOVIEW HEMOPRO SILICONE JAW CRACKED. THIS WAS NOTICED WHEN THE HARVESTER TOOK OUT THE DEVICE FROM THE PT'S LEG, BECAUSE SMOKE HAD BEEN NOTICED. WHEN THE SCRUB TECH WENT TO WIPE THE JAWS, THEY NOTICED EXPOSED METAL AND MISSING SILICONE. THEY LOOKED IN THE TUNNEL AND WERE ABLE TO RETRIEVE THE BROKEN PIECE OF SILICONE. A REPLACEMENT UNIT WAS USED TO COMPLETE THE PROCEDURE. THE HOSPITAL DID NOT REPORT ANY PT EFFECTS. THE PRODUCT IS RETURNING.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other