BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVH

    MDR report key: 9031589 · Received September 13, 2019

    Report

    Report Number
    2242352-2019-01024
    Event Type
    Malfunction
    Date Received
    September 13, 2019
    Date of Event
    August 12, 2019
    Report Date
    October 18, 2019
    Manufacturer
    MAQUET CARDIOVASCULAR LLC
    Product Code
    GEI
    PMA / PMN Number
    K052274
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    TRACKWISE # (B)(4). THE DEVICE WAS RETURNED TO THE FACTORY FOR EVALUATION. AN INVESTIGATION WAS CONDUCTED ON 10/14/2019. A VISUAL INSPECTION WAS CONDUCTED. SIGNS OF CLINICAL USE AND EVIDENCE OF BLOOD WAS OBSERVED. BLOOD AND CHARRED TISSUE WAS OBSERVED ON THE HEATER WIRE. THE HEATER WIRE WAS OBSERVED TO BE COMPLETELY FLEXED AWAY FROM THE HOT JAW AT THE CENTER, BUT REMAINED ATTACHED AT THE BASE AND TIP OF THE HOT JAW. THE SILICONE INSULATION ON THE BOTH THE COLD AND HOT JAWS WAS OBSERVED TO BE PEELED AWAY FROM BOTH JAWS, EXPOSING THE METAL PORTIONS OF THE METAL JAWS. THE DETACHED SILICONE WAS NOT RETURNED FOR EVALUATION. THE REMAINING SILICONE OF BOTH THE HOT AND COLD JAW WAS OBSERVED TO BE CHARRED AND MELTED. NO OTHER VISUAL DEFECTS WERE OBSERVED. A PRE-CAUTERY TEST WAS PERFORMED PER THE INSTRUCTION FOR USE (IFU CV000006799) WITH A REFERENCE CABLE AND REFERENCE POWER SUPPLY VH-3010 AT LEVEL 2.5. THE DEVICE FAILED THE PRE-CAUTERY TEST; IT DID NOT ACTIVATE OR PRODUCE STEAM DURING SEVERAL ACTIVATIONS OVER A PERIOD OF 10 MINUTES. THE PRE-CAUTERY TEST WAS REPEATED 5 TIMES WHILE THE CABLE CONNECTIONS WERE MANIPULATED WITH THE SAME OBSERVED FAILURE. DURING THE MANIPULATION OF THE CABLE WIRES, THE BEEPING SOUND OF THE DEVICE WAS HEARD INTERMITTENTLY INDICATING A WEAK ELECTRICAL CONNECTION WITHIN THE CIRCUIT. THE TOOL HANDLE WAS OPENED TO EVALUATE THE INTERNAL SWITCH. THE SWITCH WAS EXAMINED UNDER MICROSCOPIC CAMERA. NO RESIDUE OR CONTAMINATION WAS SEEN ON THE INTERNAL SWITCH. NO VISIBLE DEFECTS WERE OBSERVED TO THE TOGGLE. THE SHAFT TIP WAS OPENED TO EXAMINE THE INTERNAL WIRE. A CUT WAS OBSERVED ON THE INSULATION AT THE POSITION WHERE THE SHAFT PIN IS INSERTED. A CONNECTIVELY TEST WAS PERFORMED TO CHECK IF THERE WAS ANY CONNECTION ISSUE BETWEEN THE JAWS AND THE INSULATED INNER WIRE. NO CONNECTIVITY ISSUES WERE OBSERVED. THE INSULATION COVERINGS ON THE SOLDERING SITE BETWEEN THE SWITCH AND THE WIRE WAS REMOVED TO CHECK FOR DEFECTS. NO DEFECTS WERE OBSERVED. THERE WAS NO CONNECTION ISSUE BETWEEN THE SWITCH AND THE WIRE. A CONNECTIVITY TEST WAS PERFORMED TO TEST THE CONNECTION OF THE PIGTAIL TO THE SWITCH. THE CONNECTIVELY TEST FAILED. THERE WAS NO CONNECTION OBSERVED AT THE ON/OFF TERMINAL AND THE PIGTAIL INTERNAL WIRE. UPON OBSERVING THE PIGTAIL TERMINALS, NO VISUAL DEFECTS WERE OBSERVED. BASED ON THE RETURNED CONDITION OF THE DEVICE AND THE EVALUATION RESULTS, THE REPORTED COMPLAINT FOR FAILURE "SELF-ACTIVATION" WAS NOT CONFIRMED, BUT WAS CONFIRMED FOR THE ANALYZED FAILURES "THERMAL DECOMPOSITION" , "MATERIAL TWISTED; BENT", "FAILURE TO DELIVER ENERGY" AND "PEELED". SPECIFIC ACTIONS FOR THE REPORTED FAILURE "FAILURE TO DELIVER ENERGY" ARE BEING MAINTAINED AND DOCUMENTED UNDER MAQUET¿S CAPA SYSTEM.

    Description of Event or Problem · 0

    THE HOSPITAL REPORTED THAT POST USE AN ENDOSCOPIC VEIN HARVESTING PROCEDURE, VASOVIEW HEMOPRO TURNED ON BY ITSELF. THE INSTRUMENT TIPS WERE NOT TOUCHING THE PATIENT. THE SURGICAL TECH NOTICED AS THEY WERE REACHING OVER THE DEVICE THAT IT WAS ACTIVATED. THE HOSPITAL DID NOT REPORT ANY PATIENT EFFECTS.

    Additional Manufacturer Narrative · 1

    TRACKWISE #(B)(4). 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 POST USE AN ENDOSCOPIC VEIN HARVESTING PROCEDURE, VASOVIEW HEMOPRO TURNED ON BY ITSELF. THE INSTRUMENT TIPS WERE NOT TOUCHING THE PATIENT. THE SURGICAL TECH NOTICED AS THEY WERE REACHING OVER THE DEVICE THAT IT WAS ACTIVATED. THE HOSPITAL DID NOT REPORT ANY PATIENT EFFECTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    820599 EVH ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI MAQUET CARDIOVASCULAR LLC VASOVIEWHEMPRO (US) VH-3000

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR