BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVH

    MDR report key: 8971221 · Received September 6, 2019

    Report

    Report Number
    2242352-2019-01012
    Event Type
    Malfunction
    Date Received
    September 6, 2019
    Date of Event
    August 13, 2019
    Report Date
    September 6, 2019
    Manufacturer
    MAQUET CARDIOVASCULAR LLC
    Product Code
    GEI
    PMA / PMN Number
    K052274
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    INTERNAL COMPLAINT NUMBER: (B)(4).

    Description of Event or Problem · 0

    THE HOSPITAL REPORTED THAT DURING AN ENDOSCOPIC VEIN HARVESTING PROCEDURE, VASOVIEWHEMOPRO STAYED ACTIVATED AFTER THE HARVESTER RELEASED THE TRIGGER, THE HARVESTER REMOVED THE DEVICE FROM THE HARVESTING CANULA AND HAD TO UNPLUG IT TO STOP IT FROM STAYING ACTIVE. A REPLACEMENT DEVICE WAS USED TO COMPLETE THE PROCEDURE. THE HOSPITAL DI D NOT REPORT ANY PATIENT EFFECTS.

    Additional Manufacturer Narrative · 1

    (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. DEVICE NOT RETURNED.

    Description of Event or Problem · 1

    THE HOSPITAL REPORTED THAT DURING AN ENDOSCOPIC VEIN HARVESTING PROCEDURE, VASOVIEWHEMOPRO STAYED ACTIVATED AFTER THE HARVESTER RELEASED THE TRIGGER, THE HARVESTER REMOVED THE DEVICE FROM THE HARVESTING CANULA AND HAD TO UNPLUG IT TO STOP IT FROM STAYING ACTIVE. A REPLACEMENT DEVICE WAS USED TO COMPLETE THE PROCEDURE. THE HOSPITAL DI D NOT REPORT ANY PATIENT EFFECTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    766652 EVH ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI MAQUET CARDIOVASCULAR LLC VASOVIEWHEMPRO (US) VH-3000 25147157

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR