BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VASOVIEW 7 XB

    MDR report key: 6768913 · Received August 4, 2017

    Report

    Report Number
    2242352-2017-00748
    Event Type
    Malfunction
    Date Received
    August 4, 2017
    Date of Event
    July 12, 2017
    Report Date
    August 4, 2017
    Manufacturer
    MAQUET CV
    Product Code
    GEI
    PMA / PMN Number
    K041981
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE VV7 BISECTOR DEVICE WAS RETURNED TO THE FACTORY FOR EVALUATION. SIGNS OF CLINICAL USE WAS OBSERVED NO EVIDENCE OF BLOOD WERE 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 (RECOMMENDED SETTING OF 18) 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. BASED ON THE RESULTS OF THE EVALUATION, THE REPORTED COMPLAINT WAS NOT CONFIRMED FOR THE REPORTED FAILURE MODE "FAILURE TO DELIVER ENERGY".

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

    Description of Event or Problem · 1

    THE HOSPITAL REPORTED THAT DURING AN ENDOSCOPIC VEIN HARVESTING PROCEDURE, VASOVIW 7XB CUTTING DEVICE DID NOT WORK. A REPLACEMENT DEVICE WAS USED TO COMPLETE THE PROCEDURE. THE HOSPITAL DID NOT REPORT ANY PATIENT EFFECTS.

    Description of Event or Problem · 1

    THE HOSPITAL REPORTED THAT DURING AN ENDOSCOPIC VEIN HARVESTING PROCEDURE, VASOVIW 7XB CUTTING DEVICE DID NOT WORK. A REPLACEMENT DEVICE WAS USED TO COMPLETE THE PROCEDURE. THE HOSPITAL DID NOT REPORT ANY PATIENT EFFECTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    549487 VASOVIEW 7 XB ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI MAQUET CV 25132654

    Patients

    Seq Age Sex Outcome Treatment
    1