BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVH

    MDR report key: 8922449 · Received August 22, 2019

    Report

    Report Number
    2242352-2019-00965
    Event Type
    Malfunction
    Date Received
    August 22, 2019
    Date of Event
    July 29, 2019
    Report Date
    August 22, 2019
    Manufacturer
    MAQUET CARDIOVASCULAR LLC
    Product Code
    GEI
    PMA / PMN Number
    K052274
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THE DEVICE WAS RETURNED FOR EVALUATION. AN INVESTIGATION WAS CONDUCTED ON 09/12/2019. A VISUAL INSPECTION WAS CONDUCTED. SIGNS OF CLINICAL USE AND SLIGHT BLOOD WAS OBSERVED. BLOOD AND CHARRED TISSUE WAS OBSERVED ON THE HEATER WIRE AS WELL AS ON THE HARVESTING HANDLE. THE HEATER WIRE WAS OBSERVED TO BE FLEXED AWAY FROM THE HOT JAW AT THE CENTER, REMAINING ATTACHED TO THE BASE AND TIP OF THE HOT JAW. THE SILICONE INSULATION ON THE COLD JAW WAS OBSERVED TO BE PEELED AWAY FROM THE COLD JAW, EXPOSING THE METAL PORTION OF THE COLD JAW. THE DETACHED SILICONE WAS NOT RETURNED FOR EVALUATION. BASED ON THE RETURN CONDITION OF THE DEVICE, THE REPORTED FAILURE "PEELED JAW" WAS CONFIRMED AS WELL AS FOR THE ANALYZED FAILURE "MATERIAL TWISTED; BENT WIRE" WAS CONFIRMED.

    Description of Event or Problem · 0

    THE HOSPITAL REPORTED THAT DURING AN ENDOSCOPIC VEIN HARVESTING PROCEDURE, TWO PIECES OF THE VASOVIEW HEMOPRO JAWS FELL OFF IN PATIENT AND WERE ABLE TO BE RETRIEVED. A REPLACEMENT DEVICE WAS USED TO COMPLETE THE PROCEDURE. THE HOSPITAL DID NOT REPORT ANY PATIENT EFFECTS.

    Additional Manufacturer Narrative · 1

    TRACKWISE # (B)(6). 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, TWO PIECES OF THE VASOVIEW HEMOPRO JAWS FELL OFF IN PATIENT AND WERE ABLE TO BE RETRIEVED. 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
    714019 EVH ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI MAQUET CARDIOVASCULAR LLC VASOVIEWHEMPRO (US) VH-3000

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention