BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVH

    MDR report key: 9071742 · Received September 16, 2019

    Report

    Report Number
    2242352-2019-01035
    Event Type
    Malfunction
    Date Received
    September 16, 2019
    Date of Event
    August 21, 2019
    Report Date
    September 16, 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
    PHYSICIAN ASSISTANT

    Narratives

    Additional Manufacturer Narrative · 0

    TRACKWISE ID#: (B)(4). A LOT HISTORY RECORD REVIEW WAS COMPLETED FOR LOTS 25147347, 25147031,25146940; THE LAST 3 LOTS SHIPPED TO THE ACCOUNT PRIOR TO THE EVENT DATE. THERE WERE NO NCMR'S RECORDED FOR LOT #25147347, AND LOT#25146940. THERE WAS ONE NCMR REPORTED FOR LOT#25147031, WHICH IS NOT RELATED TO THE REPORTED EVENT. DEVICE SCRAPPED.

    Description of Event or Problem · 0

    THE HOSPITAL REPORTED THAT DURING AN ENDOSCOPIC VEIN HARVESTING PROCEDURE, VASOVIEW HEMOPRO HAD A PROBLEM WITH THE CAUTERY PART OF THE EVH DEVICE GETTING STUCK. NOT SLIDING WELL AT ALL. A REPLACEMENT DEVICE WAS USED TO COMPLETE THE PROCEDURE. THE HOSPITAL DID NOT REPORT ANY PATIENT EFFECTS.

    Additional Manufacturer Narrative · 1

    TRACKWISE # (B)(4). SINCE THE DEVICE IS NOT AVAILABLE TO BE RETURNED TO US, A TECHNICAL EVALUATION CANNOT BE PERFORMED. PER OUR STANDARD SOP'S, ALL EVENTS ARE TRACKED AND TRENDED TO DETERMINE WHETHER OR NOT ANY TRENDS DEVELOP. DEVICE SCRAPPED.

    Description of Event or Problem · 1

    THE HOSPITAL REPORTED THAT DURING AN ENDOSCOPIC VEIN HARVESTING PROCEDURE, VASOVIEW HEMOPRO HAD A PROBLEM WITH THE CAUTERY PART OF THE EVH DEVICE GETTING STUCK. NOT SLIDING WELL AT ALL. 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
    865523 EVH ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI MAQUET CARDIOVASCULAR LLC VASOVIEWHEMPRO (US) VH-3000

    Patients

    Seq Age Sex Outcome Treatment
    1