BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVH

    MDR report key: 10233014 · Received July 6, 2020

    Report

    Report Number
    2242352-2020-00574
    Event Type
    Injury
    Date Received
    July 6, 2020
    Date of Event
    June 12, 2020
    Report Date
    July 5, 2020
    Manufacturer
    MAQUET CARDIOVASCULAR LLC
    Product Code
    GEI
    PMA / PMN Number
    K153194
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    TRACKWISE # (B)(4). UPDATED SECTIONS: D4, G4, G7, H2, H6, H10. CORRECTED SECTION: H3- CODE CHANGED TO "DEVICE DISCARDED" H3 OTHER TEXT : DEVICE DISCARDED.

    Description of Event or Problem · 0

    THE HOSPITAL REPORTED THAT DURING AN ENDOSCOPIC VEIN HARVESTING PROCEDURE,VASOVIEW HEMOPRO VH-3500, GREY SILICONE COVER AROUND JAW WAS DISLODGED. THERMAL INJURY WAS NOTED TO THE PATIENT'S VEIN. HARVESTER ABORTED HARVEST, OPENED A NEW EVH KIT, AND RETRIEVED A CONDUIT LENGTH FROM THE OTHER LEG. THE HOSPITAL DID NOT REPORT ANY PATIENT.

    Additional Manufacturer Narrative · 1

    TRACKWISE ID# (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 VH-3500, GREY SILICONE COVER AROUND JAW WAS DISLODGED. THERMAL INJURY WAS NOTED TO THE PATIENT'S VEIN. HARVESTER ABORTED HARVEST, OPENED A NEW EVH KIT, AND RETRIEVED A CONDUIT LENGTH FROM THE OTHER LEG. THE HOSPITAL DID NOT REPORT ANY PATIENT EFFECTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    696949 EVH ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI MAQUET CARDIOVASCULAR LLC VASOVIEWHEMPRO VH-3500 25150561

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention