BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VASOVIEW HEMOPRO 2

    MDR report key: 6410828 · Received March 16, 2017

    Report

    Report Number
    2242352-2017-00256
    Event Type
    Malfunction
    Date Received
    March 16, 2017
    Report Date
    March 16, 2017
    Manufacturer
    MAQUET CV
    Product Code
    GEI
    PMA / PMN Number
    K101274
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A LOT HISTORY RECORD REVIEW WAS COMPLETED FOR LOTS 25130213, 25130105 AND 25129616 THE LAST 3 LOTS SHIPPED TO THE ACCOUNT PRIOR TO THE EVENT DATE. THERE WAS NO NONCONFORMANCE WHICH COULD BE CONSIDERED RELATED TO THE REPORTED EVENT RECORDED IN THE LOT HISTORY.

    Additional Manufacturer Narrative · 1

    (B)(6) 2017 12:42 PM (GMT-4:00) ADDED BY (B)(6) (PID-000957): INTERNAL COMPLAINT NUMBER TRACKWISE # 133023 AUTONUMBER # CS-CPL-2017-00188 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.

    Description of Event or Problem · 1

    THE HOSPITAL REPORTED THAT DURING AN ENDOSCOPIC VEIN HARVESTING PROCEDURE, VASOVIEW HEMOPRO 2 PA MENTIONED THAT HE HAD A CASE WITH A DEVICE THAT REDUCED EFFECTIVE CUTTING AND SEALING DURING OPERATION. THE HOSPITAL DID NOT REPORT ANY PATIENT EFFECTS.

    Description of Event or Problem · 1

    THE HOSPITAL REPORTED THAT DURING AN ENDOSCOPIC VEIN HARVESTING PROCEDURE, VASOVIEW HEMOPRO 2 PA MENTIONED THAT HE HAD A CASE WITH A DEVICE THAT REDUCED EFFECTIVE CUTTING AND SEALING DURING OPERATION. THE HOSPITAL DID NOT REPORT ANY PATIENT EFFECTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    191515 VASOVIEW HEMOPRO 2 ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI MAQUET CV

    Patients

    Seq Age Sex Outcome Treatment
    1