BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VASOVIEW 7 XB

    MDR report key: 5219027 · Received November 11, 2015

    Report

    Report Number
    2242352-2015-01252
    Event Type
    Malfunction
    Date Received
    November 11, 2015
    Date of Event
    October 13, 2015
    Report Date
    October 19, 2015
    Manufacturer
    MAQUET CV
    Product Code
    GEI
    PMA / PMN Number
    K041981
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) 2015 09:30 AM (GMT-5:00) ADDED BY (B)(4): THE DEVICE HAS BEEN RETURNED TO THE FACTORY AND IS BEING EVALUATED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETED. A LOT HISTORY RECORD REVIEW WAS COMPLETED FOR THE REPORTED PRODUCT LOT NUMBER. THERE WAS NO NONCONFORMANCE RECORDED IN THE LOT HISTORY.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RETURNED TO THE FACTORY FOR EVALUATION. SIGNS OF BLOOD AND CLINICAL USE WERE OBSERVED. A MECHANICAL EVALUATION OF THE HEMORO BISECTOR BLADE SLIDER WAS CONDUCTED AND COMPARED TO REFERENCE C-VH-3200 . THE SWITCH WAS ABLE TO ADVANCE AND RETRACT THE BLADE. NO STICKING/RESISTANCE WHICH COULD BE CONSIDERED EXCESSIVE WAS OBSERVED. BASED ON THE RETURNED CONDITION OF THE DEVICE AND THE RESULTS OF THE INVESTIGATION, THE REPORTED COMPLAIN WAS NOT CONFIRMED. (B)(4).

    Description of Event or Problem · 1

    THE HOSPITAL REPORTED THAT DURING AN ENDOSCOPIC VEIN HARVESTING PROCEDURE, VASOVIEW7 XB BUTTONS KEPT STICKING. THE HOSPITAL DID NOT REPORT ANY PATIENT EFFECTS.

    Description of Event or Problem · 1

    THE HOSPITAL REPORTED THAT DURING AN ENDOSCOPIC VEIN HARVESTING PROCEDURE, VASOVIEW7 XB BUTTONS KEPT STICKING. THE HOSPITAL DID NOT REPORT ANY PATIENT EFFECTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    747160 VASOVIEW 7 XB ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI MAQUET CV 25116124

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR