BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVH

    MDR report key: 8898532 · Received August 15, 2019

    Report

    Report Number
    2242352-2019-00936
    Event Type
    Malfunction
    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
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    INTERNAL COMPLAINT NUMBER: (B)(4). THE DEVICE WAS RETURNED TO THE FACTORY FOR EVALUATION. A VISUAL INSPECTION WAS CONDUCTED ON 09/06/2019. SIGNS OF CLINICAL USE AND EVIDENCE OF BLOOD WAS OBSERVED. BLOOD OBSERVED ON THE HARVESTING HANDLE AND BLOOD AND CHARRED TISSUE WAS OBSERVED ON THE JAWS. THE HEATER WIRE WAS OBSERVED TO COMPLETELY FLEXED AWAY FROM THE CENTER OF THE HOT JAW, WITH DETACHMENT AT THE TIP OF THE HOT JAW, BUT REMAINED ATTACHED AT THE BASE OF THE HOT JAW. THE SILICONE INSULATION ON THE HOT JAW WAS OBSERVED TO BE PEELED AWAY FROM THE JAW, EXPOSING THE PORTION FROM THE MIDDLE OF THE HOT JAW TO THE TIP. THE SILICONE ON THE COLD JAW WAS ALSO OBSERVED TO BE PEELED AWAY FROM THE SIDE OF THE COLD JAW, EXPOSING THE METAL PORTION OF THE COLD JAW. THE PEELED SILICONE WAS NOT RETURNED FOR EVALUATION. AN ELECTRICAL EVALUATION WAS CONDUCTED. 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 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 "PEELED" WAS CONFIRMED.

    Description of Event or Problem · 0

    THE HOSPITAL REPORTED THAT DURING AN ENDOSCOPIC VEIN HARVESTING PROCEDURE, VASOVIEW HEMOPRO WOULD NOT TURN OFF. A REPLACEMENT DEVICE WAS USED TO COMPLETE THE PROCEDURE. THE HOSPITAL DID NOT REPORT ANY PATIENT EFFECTS.

    Additional Manufacturer Narrative · 1

    (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 DURING AN ENDOSCOPIC VEIN HARVESTING PROCEDURE, VASOVIEW HEMOPRO WOULD NOT TURN OFF. 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
    691824 EVH ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI MAQUET CARDIOVASCULAR LLC VASOVIEWHEMPRO (US) VH-3000 25146747

    Patients

    Seq Age Sex Outcome Treatment
    1