BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVH

    MDR report key: 8899513 · Received August 15, 2019

    Report

    Report Number
    2242352-2019-00950
    Event Type
    Injury
    Date Received
    August 15, 2019
    Date of Event
    July 23, 2019
    Report Date
    August 15, 2019
    Manufacturer
    MAQUET CARDIOVASCULAR LLC
    Product Code
    GEI
    PMA / PMN Number
    K052274
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    TRACKWISE # (B)(4). THE DEVICE WAS RETURNED TO THE FACTORY FOR EVALUATION ON 09/17/2019 AND INVESTIGATED ON 10/24/2019. A VISUAL INSPECTION WAS CONDUCTED. SIGNS OF CLINICAL USE WERE OBSERVED. CHARRED TISSUE AND BLOOD WAS OBSERVED ON THE HEATER WIRE. THE HEATER WIRE WAS OBSERVED TO BE SLIGHTLY FLEXED AWAY FROM THE HOT JAW AT THE CENTER, BUT REMAINED ATTACHED AT THE BASE AND TIP. THE SILICONE INSULATION WAS OBSERVED TO BE INTACT, NO VISUAL DEFECTS WERE OBSERVED. 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 MODE ¿MATERIAL TWISTED/BENT¿ WAS CONFIRMED.

    Description of Event or Problem · 0

    THE HOSPITAL REPORTED THAT DURING AN ENDOSCOPIC VEIN HARVESTING PROCEDURE, VASOVIEW HEMOPRO STAYED ACTIVATED (ON) WHEN IT WAS NOT IN USE AND THE PATIENT WAS BURNED ON THE LEG. THE LEG INCISION IS HEALING WELL AND WITH OUT SIGNS OF INFECTION. 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. SINCE THE DEVICE IS NOT AVAILABLE TO BE RETURNED TO US, A TECHNICAL EVALUATION CANNOT BE PERFORMED. PER OUR STANDARD SOP'S, ALL EVENTS ARE TRACKED AND TRENDED TO DETERMINE WHETHER OR NOT ANY TRENDS DEVELOP. DEVICE SCRAPPED.

    Description of Event or Problem · 1

    THE HOSPITAL REPORTED THAT DURING AN ENDOSCOPIC VEIN HARVESTING PROCEDURE, VASOVIEW HEMOPRO STAYED ACTIVATED (ON) WHEN IT WAS NOT IN USE AND THE PATIENT WAS BURNED ON THE LEG. THE LEG INCISION IS HEALING WELL AND WITHOUT SIGNS OF INFECTION. 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
    691284 EVH ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI MAQUET CARDIOVASCULAR LLC VASOVIEWHEMPRO (US) VH-3000 25146630

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention