BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVH

    MDR report key: 9888005 · Received March 27, 2020

    Report

    Report Number
    2242352-2020-00313
    Event Type
    Injury
    Date Received
    March 27, 2020
    Date of Event
    March 4, 2020
    Report Date
    March 25, 2020
    Manufacturer
    MAQUET CARDIOVASCULAR LLC
    Product Code
    GEI
    PMA / PMN Number
    K052274
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). A LOT HISTORY RECORD REVIEW WAS COMPLETED FOR LOTS 25150193, 25149980, AND 25150014, THE LAST 3 LOTS SHIPPED TO THE ACCOUNT PRIOR TO THE EVENT DATE. THERE WERE NO NCMRS FOR THE LAST 3 LOT #S FROM SHIP HISTORY.

    Description of Event or Problem · 0

    THE HOSPITAL REPORTED THAT DURING AN ENDOSCOPIC VEIN HARVESTING PROCEDURE, VASOVIEW HEMOPRO GREY SILICONE PIECE SEPARATED AND CAME OFF THE JAWS AND ENDED UP IN THE TUNNEL. THE DETACHED PIECE WAS RETRIEVED BY THE HARVESTER WITH A SECOND HEMOPRO AND IT WAS USED TO COMPLETE THE CASE. THE HOSPITAL DID NOT REPORT ANY PATIENT EFFECTS.

    Additional Manufacturer Narrative · 1

    TRACKWISE ID# (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 NOT RETURNED.

    Description of Event or Problem · 1

    THE HOSPITAL REPORTED THAT DURING AN ENDOSCOPIC VEIN HARVESTING PROCEDURE, VASOVIEW HEMOPRO GREY SILICONE PIECE SEPARATED AND CAME OFF THE JAWS ANDENDED UP IN THE TUNNEL. THE DETACHED PIECE WAS RETRIEVED BY THE HARVESTER WITH A SECOND HEMOPRO AND IT WAS USED TO COMPLETE THE CASE. THE HOSPITAL DID NOT REPORT ANY PATIENT EFFECTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    350868 EVH ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI MAQUET CARDIOVASCULAR LLC VASOVIEWHEMPRO (US) VH-3000

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention