BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VASOVIEW 7 XB

    MDR report key: 5247428 · Received November 24, 2015

    Report

    Report Number
    2242352-2015-01301
    Event Type
    Injury
    Date Received
    November 24, 2015
    Date of Event
    October 16, 2015
    Report Date
    October 27, 2015
    Manufacturer
    MAQUET CV
    Product Code
    GEI
    PMA / PMN Number
    K041981
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RETURNED TO THE FACTORY AND IS BEING EVALUATED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETED.

    Additional Manufacturer Narrative · 1

    (B)(4). A LOT HISTORY RECORD REVIEW WAS COMPLETED FOR THE REPORTED PRODUCT LOT NUMBER. THERE WAS NO NONCONFORMANCE RECORDED IN THE LOT HISTORY. THE DEVICE WAS RETURNED TO THE FACTORY FOR EVALUATION. EVIDENCE OF CLINICAL USE WS OBSERVED. NO VISUAL DEFECTS WERE OBSERVED. THE DEVICE WAS EVALUATED FOR ELECTRICAL FUNCTION. A PRE-CAUTERY TEST WAS PERFORMED AND REPEATED 10 TIMES OVER A 10 MINUTE PERIOD ACCORDING TO THE PROCEDURE IN THE INSTRUCTIONS FOR USE. THE DEVICE PASSED THE PRE-CAUTERY TEST WITH A REFERENCE GENERATOR SET TO 18 WATTS AND REFERENCE BIPOLAR CORD. THE BIPOLAR CORD CONNECTION WAS MANIPULATED DURING ACTIVATION. THE DEVICE REMAINED ACTIVE AND NO INTERMITTENT CONTINUITY WAS OBSERVED. THE DEVICE PRODUCED STEAM AND THE SALINE WAS OBSERVED TO ¿BOIL¿ ON THE TEST GAUZE EACH TIME. THE DEVICE WAS EVALUATED FOR CAUTERY FUNCTION. THE DEVICE WAS ABLE TO TRANSECT REFERENCE VESSEL FIVE TIMES WITH NO OBSERVED DIFFICULTY. BASED ON THE RESULTS OF THE EVALUATION, THE REPORTED COMPLAINT WAS UNABLE TO BE CONFIRMED. WE WERE UNABLE TO REPRODUCE THE REPORTED FAILURE IN OUR TESTING. (B)(4).

    Description of Event or Problem · 1

    THE HOSPITAL REPORTED THAT DURING AN ENDOSCOPIC VEIN HARVESTING PROCEDURE, THE VASOVIEW 7 XB WAS UNABLE TO CUT. THE BIPOLAR WAS UNAVAILABLE. THE ENDOSCOPIC VEIN HARVEST WAS CONVERTED TO AN OPEN PROCEDURE. THE HOSPITAL DID NOT REPORT ANY PATIENT EFFECTS. AFTER THE PROCEDURE THE STAFF CONFIRMED THAT THE BIPOLAR CORD WAS DISCONNECTED, AND THERE WAS NO PROBLEM WITH THE DEVICE. THE ELECTROSURGICAL UNIT WAS AVAILABLE. THEREFORE, THE SURGEON PRESUMED THE BISECTOR HAD A PROBLEM. THE PRODUCT IS RETURNING.

    Description of Event or Problem · 1

    THE HOSPITAL REPORTED THAT DURING AN ENDOSCOPIC VEIN HARVESTING PROCEDURE, THE VASOVIEW 7 XB WAS UNABLE TO CUT. THE BIPOLAR WAS UNAVAILABLE. THE ENDOSCOPIC VEIN HARVEST WAS CONVERTED TO AN OPEN PROCEDURE. THE HOSPITAL DID NOT REPORT ANY PATIENT EFFECTS. AFTER THE PROCEDURE THE STAFF CONFIRMED THAT THE BIPOLAR CORD WAS DISCONNECTED, AND THERE WAS NO PROBLEM WITH THE DEVICE. THE ELECTROSURGICAL UNIT WAS AVAILABLE. THEREFORE, THE SURGEON PRESUMED THE BISECTOR HAD A PROBLEM. THE PRODUCT IS RETURNING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    777948 VASOVIEW 7 XB ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI MAQUET CV 25116338

    Patients

    Seq Age Sex Outcome Treatment
    1 Other