BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVH

    MDR report key: 8944264 · Received August 29, 2019

    Report

    Report Number
    2242352-2019-00987
    Event Type
    Injury
    Date Received
    August 29, 2019
    Date of Event
    July 24, 2019
    Report Date
    August 28, 2019
    Manufacturer
    MAQUET CARDIOVASCULAR LLC
    Product Code
    GEI
    PMA / PMN Number
    K052274
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    TRACKWISE ID # (B)(4). THE DEVICE WAS RETURNED TO THE FACTORY FOR EVALUATION. AN INVESTIGATION WAS CONDUCTED ON (B)(6) 2019. SIGNS OF CLINICAL USE AND EVIDENCE OF BLOOD WAS OBSERVED ON THE HARVESTING HANDLE. A MICROSCOPIC INSPECTION WAS CONDUCTED. EXCESSIVE BLOOD AND CHARRED TISSUE WAS OBSERVED ON THE HEATER WIRE. THE HEATER WIRE WAS OBSERVED TO BE SLIGHTLY FLEXED AWAY AT THE CENTER OF THE HOT JAW, BUT REMAINED ATTACHED AT THE BASE AND TIP OF THE HOT JAW . THE SILICONE INSULATION ON THE COLD JAW WAS OBSERVED TO BE PEELED OFF FROM THE BASE OF THE COLD JAW TO THE MIDDLE PORTION OF THE COLD JAW, EXPOSING THE METAL PORTION OF THE COLD JAW. THE DETACHED SILICONE WAS NOT RETURNED FOR EVALUATION. BASED ON THE RETURNED CONDITION OF THE DEVICE, AND THE RESULTS OF THE INVESTIGATION, THE REPORTED FAILURE "PEELED JAW" WAS CONFIRMED AS WELL AS FOR THE ANALYZED FAILURE "MATERIAL TWISTED/BENT".

    Description of Event or Problem · 0

    THE HOSPITAL REPORTED THAT DURING AN ENDOSCOPIC VEIN HARVESTING PROCEDURE VASOVIEW HEMOPRO PIECE OF THE JAW CAME OFF BUT WAS RETRIEVED. 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 PIECE OF THE JAW CAME OFF BUT WAS 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
    737875 EVH ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI MAQUET CARDIOVASCULAR LLC VASOVIEWHEMPRO (US) VH-3000 25146940

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention