BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VASO VIEW HEMOPRO

    MDR report key: 5535840 · Received March 30, 2016

    Report

    Report Number
    2242352-2016-00304
    Event Type
    Injury
    Date Received
    March 30, 2016
    Date of Event
    February 17, 2016
    Report Date
    March 3, 2016
    Manufacturer
    MAQUET CV
    Product Code
    GEI
    PMA / PMN Number
    K052274
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    UPDATE 03/29/2016 02:59 PM (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. (B)(4).

    Additional Manufacturer Narrative · 1

    A LOT HISTORY RECORD REVIEW WAS COMPLETED FOR LOTS 25120317, 25120595 AND 25121053 THE LAST 3 LOTS SHIPPED TO THE ACCOUNT PRIOR TO THE EVENT DATE. THERE WAS NO NONCONFORMANCE RECORDED IN THE LOT HISTORY. (B)(4). A LOT HISTORY RECORD REVIEW WAS COMPLETED THE LAST 3 LOTS SHIPPED TO THE ACCOUNT PRIOR TO THE EVENT DATE. THERE WAS NO NONCONFORMANCE RECORDED IN THE LOT HISTORY

    Description of Event or Problem · 1

    UPDATE 03/04/2016 12:50 PM (B)(4): THE HOSPITAL REPORTED THAT DURING AN ENDOSCOPIC VEIN HARVESTING PROCEDURE , VASOVIEW HEMOPRO WAS USED. A PATIENT HAS BEEN DIAGNOSED WITH FOOT DROP IN THE PAST 6-8 MONTHS. THE PRODUCT IS NOT RETURNING. ******************************************************************************************* UPDATE 03/03/2016 01:38 PM (B)(4): (B)(6) HAS HAD 2 PATIENTS WITH "FOOT DROP" IN THE PAST 6-8 MONTHS.

    Description of Event or Problem · 1

    THE HOSPITAL REPORTED THAT DURING AN ENDOSCOPIC VEIN HARVESTING PROCEDURE , VASOVIEW HEMOPRO WAS USED. A PATIENT HAS BEEN DIAGNOSED WITH FOOT DROP IN THE PAST 6-8 MONTHS. THE PRODUCT IS NOT RETURNING. (B)(6) SAID THAT THEY (NMH) HAS HAD 2 PATIENTS WITH "FOOT DROP" IN THE PAST 6-8 MONTHS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    190051 VASO VIEW HEMOPRO ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI MAQUET CV

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Other