BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VASO VIEW HEMOPRO

    MDR report key: 7325623 · Received March 8, 2018

    Report

    Report Number
    2242352-2018-00224
    Event Type
    Malfunction
    Date Received
    March 8, 2018
    Date of Event
    February 15, 2018
    Report Date
    March 8, 2018
    Manufacturer
    MAQUET CV
    Product Code
    GEI
    PMA / PMN Number
    K052274
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THE DEVICE WAS RETURNED TO THE FACTORY FOR EVALUATION. A VISUAL INSPECTION WAS CONDUCTED. SIGNS OF CLINICAL USE AND EVIDENCE OF BLOOD WERE OBSERVED. CHARRED TISSUES AND BLOOD WERE EVIDENT ON THE JAWS. MICROSCOPIC INSPECTION SHOWED THE HEATER WIRE WAS SLIGHTLY FLEXED BUT REMAINED ATTACHED AT THE BASE AND TIP OF THE JAW. IT WAS OBSERVED THAT THE SILICONE INSULATION FOR BOTH COLD AND HOT JAWS WERE CHARRED, CRACKED AND WHITISH IN COLOR, WHICH ARE USUALLY CAUSED BY PROLONGED ACTIVATION LEADING TO BURNING OF THE DEVICE. AN ELECTRICAL EVALUATION WAS CONDUCTED. A PRE-CAUTERY TEST WAS PERFORMED PER THE INSTRUCTION FOR USE WITH A REFERENCE CABLE AND REFERENCE POWER SUPPLY VH-3010 AT LEVEL 2.5. THE DEVICE PASSED THE PRE-CAUTERY TEST; IT PRODUCED VISIBLE STEAM AND AUDIBLE SOUND DURING SEVERAL ACTIVATIONS OVER A PERIOD OF 10 MINUTES AND SHUT OFF WHEN THE TOGGLE WAS RELEASED. THE PRE-CAUTERY TEST WAS REPEATED 10 TIMES WITH NO OBSERVED FAILURE. THE TOOL HANDLE WAS OPENED TO EVALUATE THE INTERNAL COMPONENTS. NO VISIBLE DEFECTS WERE OBSERVED TO THE TOGGLE. MICROSCOPIC INSPECTION SHOWED NO RESIDUE OR CONTAMINATION ON THE INNER SWITCH MECHANISM. NO ELECTRICAL ISSUES WERE OBSERVED. BASED ON THE RETURNED CONDITION OF THE DEVICE AND THE RESULTS OF THE EVALUATION, THE REPORTED FAILURE MODE ¿DEVICE REMAINS ACTIVATED¿ WAS NOT CONFIRMED. BOTH ANALYZED FAILURE MODE "BENT WIRE" AND ANALYZED FAILURE MODE "THERMAL DECOMPOSITION OF DEVICE" WERE CONFIRMED.

    Description of Event or Problem · 0

    THE HOSPITAL REPORTED THAT DURING AN ENDOSCOPIC VEIN HARVESTING PROCEDURE, VASOVIEW HEMOPRO REMAINED ACTIVATED AFTER ACTIVATION SWITCH WAS RELEASED. A SECOND DEVICE WAS OPENED AND USED TO COMPLETE THE CASE WITHOUT FURTHER COMPLICATIONS OR HARM TO THE PATIENT.

    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, VASOVIEW HEMOPRO REMAINED ACTIVATED AFTER ACTIVATION SWITCH WAS RELEASED. A SECOND DEVICE WAS OPENED AND USED TO COMPLETE THE CASE WITHOUT FURTHER COMPLICATIONS OR HARM TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    167285 VASO VIEW HEMOPRO ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI MAQUET CV 25135601

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR