BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVH

    MDR report key: 8899441 · Received August 15, 2019

    Report

    Report Number
    2242352-2019-00944
    Event Type
    Malfunction
    Date Received
    August 15, 2019
    Date of Event
    July 10, 2019
    Report Date
    August 15, 2019
    Manufacturer
    MAQUET CARDIOVASCULAR LLC
    Product Code
    GEI
    PMA / PMN Number
    K052274
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (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 WAS OBSERVED ON THE HARVESTING HANDLE. BLOOD AND CHARRED TISSUE WAS OBSERVED ON THE HEATER WIRE. THE HEATER WIRE WAS OBSERVED TO BE FLEXED AWAY FROM THE HOT JAW, AT THE CENTER AND TOWARDS THE TIP OF THE HEATER WIRE, BUT REMAINED ATTACHED AT THE BASE AND TIP OF THE HOT JAW. THE SILICONE INSULATION ON THE HOT JAW WAS OBSERVED TO BE BLACKENED NEAR THE HEATER WIRE. THE SILICONE INSULATION ON THE COLD JAW WAS OBSERVED TO BE WHITISH IN COLOR. THE SILICONE INSULATION ON BOTH THE COLD JAW AND HOT JAW WAS OBSERVED TO BE INTACT. 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. BASED ON THE RETURNED CONDITION OF THE DEVICE AND THE EVALUATION RESULTS, THE REPORTED FAILURE "DEVICE REMAINS ACTIVATED" WAS NOT CONFIRMED, BUT THE ANALYZED FAILURE MODES ¿MATERIAL TWISTED/BENT¿ AND "THERMAL DECOMPOSITION OF DEVICE" WAS CONFIRMED.

    Description of Event or Problem · 0

    THE HOSPITAL REPORTED THAT DURING AN ENDOSCOPIC VEIN HARVESTING PROCEDURE, VASOVIEW HEMOPRO CAUTERY DID NOT DEACTIVATE AS IT CONTINUALLY STAYED ON (HOT). THEY IMMEDIATELY UNHOOKED THE HP CORD AT THAT TIME. THERE WAS NO PATIENT HARM OR ANY BURNS OR CHARRED AREAS INSIDE THE TUNNEL OR ANYWHERE ON THE LEG. 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 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 CAUTERY DID NOT DEACTIVATE AS IT CONTINUALLY STAYED ON (HOT). THEY IMMEDIATELY UNHOOKED THE HP CORD AT THAT TIME. THERE WAS NO PATIENT HARM OR ANY BURNS OR CHARRED AREAS INSIDE THE TUNNEL OR ANYWHERE ON THE LEG. 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
    693035 EVH ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI MAQUET CARDIOVASCULAR LLC VASOVIEWHEMPRO (US) VH-3000 25146846

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR