BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVH

    MDR report key: 8873353 · Received August 8, 2019

    Report

    Report Number
    2242352-2019-00904
    Event Type
    Malfunction
    Date Received
    August 8, 2019
    Date of Event
    July 4, 2019
    Report Date
    January 17, 2020
    Manufacturer
    MAQUET CARDIOVASCULAR LLC
    Product Code
    GEI
    PMA / PMN Number
    K091733
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTED SECTION: H-3 "DEVICE NOT EVAL PROVIDE CODE" TRACKWISE ID# (B)(4). THE DEVICE WAS RETURNED FOR EVALUATION. A FOLLOW UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETED.

    Additional Manufacturer Narrative · 0

    TRACKWISE # (B)(4) THE DEVICE WAS RETURNED TO THE FACTORY FOR EVALUATION ON 12/11/2019. AN INVESTIGATION WAS CONDUCTED ON 01/17/2020. A VISUAL INSPECTION WAS CONDUCTED. SIGNS OF CLINICAL USE AND SLIGHT EVIDENCE OF BLOOD WAS OBSERVED. SLIGHT BLOOD WAS OBSERVED ON THE ELECTRODES AS WELL AS ON THE BISECTOR BLADE. AN ELECTRICAL EVALUATION WAS CONDUCTED. 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. TO TEST THE ABILITY OF THE DEVICE TO CUT, A CAUTERY TEST WAS PERFORMED ON ARTIFICIAL VESSEL FOUR (4) TIMES. THE DEVICE COULD TRANSECT THE VESSEL WITH A CLEAN CUT WITHOUT ANY FAILURE. BASED ON THE RESULTS OF THE EVALUATION, THE REPORTED FAILURE ¿FAILURE TO CUT¿ IS NOT CONFIRMED.

    Description of Event or Problem · 0

    THE HOSPITAL REPORTED THAT DURING AN ENDOSCOPIC VEIN HARVESTING PROCEDURE, VASOVIEW 6 PRO WAS NOT CUTTING. A REPLACEMENT DEVICE WAS USED TO COMPLETE THE PROCEDURE. THE HOSPITAL DID NOT REPORT ANY PATIENT EFFECTS.

    Description of Event or Problem · 0

    THE HOSPITAL REPORTED THAT DURING AN ENDOSCOPIC VEIN HARVESTING PROCEDURE, VASOVIEW 6 PRO WAS NOT CUTTING. A REPLACEMENT DEVICE WAS USED TO COMPLETE THE PROCEDURE. THE HOSPITAL DID NOT REPORT ANY PATIENT EFFECTS.

    Additional Manufacturer Narrative · 1

    (B)(4). A LOT HISTORY RECORD REVIEW WAS COMPLETED FOR THE REPORTED PRODUCT LOT NUMBER. THERE WERE NO NCMR¿S FOR THE REPORTED LOT NUMBER. THE DEVICE HAS NOT YET BEEN RETURNED TO MAQUET CARDIAC SURGERY FOR EVALUATION. WE ARE FOLLOWING UP WITH THE CUSTOMER FOR THE RETURN OF THE DEVICE. A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF THE DEVICE IS RECEIVED. DEVICE NOT RETURNED.

    Description of Event or Problem · 1

    THE HOSPITAL REPORTED THAT DURING AN ENDOSCOPIC VEIN HARVESTING PROCEDURE, VASOVIEW 6 PRO WAS NOT CUTTING. 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
    667227 EVH ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI MAQUET CARDIOVASCULAR LLC VASOVIEW 6 PRO 25144982

    Patients

    Seq Age Sex Outcome Treatment
    1