BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVH 3000

    MDR report key: 8873355 · Received August 8, 2019

    Report

    Report Number
    2242352-2019-00905
    Event Type
    Injury
    Date Received
    August 8, 2019
    Date of Event
    July 15, 2019
    Report Date
    August 7, 2019
    Manufacturer
    MAQUET CARDIOVASCULAR LLC
    Product Code
    GEI
    PMA / PMN Number
    K052274
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4).

    Description of Event or Problem · 0

    THE HOSPITAL REPORTED THAT DURING AN ENDOSCOPIC VEIN HARVESTING PROCEDURE, VASOVIEW HEMOPRO ACTIVATED ON ITS OWN. THE PATIENT AND THE SURGEON WERE BOTH BURNED. HOSPITAL ARE NOT SURE WHERE THE BURNS ARE LOCATED ON EITHER THE PATIENT OR THE SURGEON.

    Additional Manufacturer Narrative · 1

    TRACKWISE : (B)(4). A LOT HISTORY RECORD REVIEW WAS COMPLETED FOR THE REPORTED PRODUCT LOT NUMBER. THERE WERE NO NCMR¿S FOR THE REPORTED LOT NUMBER. THE DEVICE HAS NOT YET BEEN RETURNED TO MAQUET CARDIAC SURGERY FOR EVALUATION. WE ARE FOLLOWING UP WITH THE CUSTOMER FOR THE RETURN OF THE DEVICE. A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF THE DEVICE IS RECEIVED.

    Description of Event or Problem · 1

    THE HOSPITAL REPORTED THAT DURING AN ENDOSCOPIC VEIN HARVESTING PROCEDURE, VASOVIEW HEMOPRO ACTIVATED ON ITS OWN. THE PATIENT AND THE SURGEON WERE BOTH BURNED. A REPLACEMENT DEVICE WAS USED TO COMPLETE THE PROCEDURE. THE HOSPITAL DID NOT REPORT ANY PATIENT EFFECTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    667229 EVH 3000 ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI MAQUET CARDIOVASCULAR LLC VASOVIEWHEMPRO (US) VH-3000 25146747

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Required Intervention