BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VASOVIEW HEMOPRO 2

    MDR report key: 5760274 · Received June 29, 2016

    Report

    Report Number
    2242352-2016-00607
    Event Type
    Malfunction
    Date Received
    June 29, 2016
    Date of Event
    May 11, 2016
    Report Date
    May 12, 2016
    Manufacturer
    MAQUET CV
    Product Code
    GEI
    PMA / PMN Number
    K101274
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RETURNED TO THE FACTORY FOR EVALUATION. SIGNS OF CLINICAL USE AND BLOOD WERE OBSERVED. SMALL AMOUNTS OF TISSUE AND CHARRED BLOOD WERE OBSERVED ON THE HEATING ELEMENT. EVIDENCE OF BLOOD WERE OBSERVED ON THE HARVESTING TOOL. THE DEVICE WAS EVALUATED FOR ELECTRICAL FUNCTION. A PRE-CAUTERY TEST WAS PERFORMED PER THE INSTRUCTION FOR USE (IFU) WITH A REFERENCE CABLE, ADAPTER AND REFERENCE POWER SUPPLY VH-3010 3.0. THE DEVICE PASSED THE PRE-CAUTERY TEST; IT PRODUCED VISIBLE STEAM AND HEAT DURING TEN (10) 3-SECOND ACTIVATIONS AND SHUT OFF WHEN THE TOGGLE WAS RELEASED. TO EVALUATE THE SAFETY SHUT DOWN SYSTEM, A POLYFUSE ACTIVATION TEST WAS PERFORMED 5 TIMES OVER 10 MINUTES. THE DEVICE SHUT OFF AFTER 18 SECONDS OF SUSTAINED ACTIVATION. THE JAWS WERE CLEANED OF DEBRIS AND CHAR GENTLY WITH SALINE AND GAUZE PAD AS INDICATED IN THE INSTRUCTIONS FOR USE. A TEMPERATURE AND RESISTANCE EVALUATION WAS CONDUCTED TO EVALUATE THE DEVICE FUNCTION. THE RESISTANCE VALUE WAS MEASURED AT 0.68 OHMS WHICH IS WITHIN HEMOPRO 2 FINAL TEST SPECIFICATION. THE DEVICE PASSED THE TEMPERATURE MEASUREMENT TEST. THE DISPLAYED TEMPERATURE INCREASED AND TURNED ¿GREEN¿ WITHIN THE 2 SECOND SPECIFIED TIMEFRAME. THE DISPLAYED TEMPERATURE DECREASED ONCE THE TOGGLE SWIVEL WAS RELEASED. BASED ON THE RESULTS OF THE EVALUATION, THE REPORTED FAILURE "INTERMITTENT CONTINUITY" IS NOT CONFIRMED.

    Additional Manufacturer Narrative · 1

    (B)(4). 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. A LOT HISTORY RECORD REVIEW WAS COMPLETED FOR THE REPORTED PRODUCT LOT NUMBER. THERE WAS NO NONCONFORMANCE RECORDED IN THE LOT HISTORY. (B)(4).

    Description of Event or Problem · 1

    THE HOSPITAL REPORTED THAT DURING AN ENDOSCOPIC VEIN HARVESTING PROCEDURE, VASOVIEW HEMOPRO 2 HAD INTERMITTENT CONTINUITY. 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, VASOVIEW HEMOPRO 2 HAD INTERMITTENT CONTINUITY. 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
    413387 VASOVIEW HEMOPRO 2 ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI MAQUET CV 25124436

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR