BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VASOVIEW 7 XB

    MDR report key: 6605772 · Received June 1, 2017

    Report

    Report Number
    2242352-2017-00538
    Event Type
    Malfunction
    Date Received
    June 1, 2017
    Date of Event
    May 9, 2017
    Report Date
    May 31, 2017
    Manufacturer
    MAQUET CV
    Product Code
    GEI
    PMA / PMN Number
    K041981
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RETURNED TO THE FACTORY FOR EVALUATION. SIGNS OF CLINICAL USE AND EVIDENCE OF BLOOD WERE OBSERVED. BLOOD WAS OBSERVED ON THE HANDLE OF THE HARVESTING TOOL. HEAVY CHAR AND TISSUE BUILD UP WAS OBSERVED ON THE BISECTOR BLADE. NO OTHER VISUAL DEFECTS WERE OBSERVED. THE DEVICE WAS EVALUATED FOR ELECTRICAL FUNCTION. A PRE-CAUTERY TEST WAS PERFORMED AND REPEATED 5 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 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 FAILURE "FAILURE TO CUT" WAS NOT CONFIRMED.

    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.

    Additional Manufacturer Narrative · 1

    (B)(6). (B)(4).

    Description of Event or Problem · 1

    THE HOSPITAL REPORTED THAT DURING AN ENDOSCOPIC VEIN HARVESTING PROCEDURE, VASOVIEW 7 XB CUSTOMER STATES THAT THERE HAS BEEN A HIGH INCIDENCE OF RETAINED TISSUE ON THE BISECTOR. THIS REQUIRES REMOVAL OF THE CUTTING TOOL TO CLEAN IT AND THEN RE INSTITUTE HARVESTING. WHEN THIS HAPPENS THE CUT AND SEAL IS COMPROMISED AND THEY HAVE HAD TO REPAIR SOME BLEEDING ISSUES. A REPLACEMENT DEVICE WAS USED TO COMPLETE THE PROCEDURE. THE HOSPITAL DID NOT REPORT ANY PATIENT EFFECTS. THE SURGICAL PA STATED THAT AFTER THE VEIN WAS REMOVED HE WENT BACK IN WITH THE CAUTERY TOOL AND WAS ABLE TO CAUTERIZE AND CONTROL THE BLEEDING.

    Description of Event or Problem · 1

    THE HOSPITAL REPORTED THAT DURING AN ENDOSCOPIC VEIN HARVESTING PROCEDURE, VASOVIEW 7 XB CUSTOMER STATES THAT THERE HAS BEEN A HIGH INCIDENCE OF RETAINED TISSUE ON THE BISECTOR. THIS REQUIRES REMOVAL OF THE CUTTING TOOL TO CLEAN IT AND THEN RE INSTITUTE HARVESTING. WHEN THIS HAPPENS THE CUT AND SEAL IS COMPROMISED AND THEY HAVE HAD TO REPAIR SOME BLEEDING ISSUES. A REPLACEMENT DEVICE WAS USED TO COMPLETE THE PROCEDURE. THE HOSPITAL DID NOT REPORT ANY PATIENT EFFECTS. THE SURGICAL PA STATED THAT AFTER THE VEIN WAS REMOVED HE WENT BACK IN WITH THE CAUTERY TOOL AND WAS ABLE TO CAUTERIZE AND CONTROL THE BLEEDING.

    Description of Event or Problem · 1

    THE HOSPITAL REPORTED THAT DURING AN ENDOSCOPIC VEIN HARVESTING PROCEDURE, VASOVIEW 7 XB CUSTOMER STATES THAT THERE HAS BEEN A HIGH INCIDENCE OF RETAINED TISSUE ON THE BISECTOR. THIS REQUIRES REMOVAL OF THE CUTTING TOOL TO CLEAN IT AND THEN RE INSTITUTE HARVESTING. WHEN THIS HAPPENS THE CUT AND SEAL IS COMPROMISED AND THEY HAVE HAD TO REPAIR SOME BLEEDING ISSUES. A REPLACEMENT DEVICE WAS USED TO COMPLETE THE PROCEDURE. THE HOSPITAL DID NOT REPORT ANY PATIENT EFFECTS. THE SURGICAL PA STATED THAT AFTER THE VEIN WAS REMOVED HE WENT BACK IN WITH THE CAUTERY TOOL AND WAS ABLE TO CAUTERIZE AND CONTROL THE BLEEDING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    385390 VASOVIEW 7 XB ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI MAQUET CV 25130936

    Patients

    Seq Age Sex Outcome Treatment
    1