BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVH

    MDR report key: 8898931 · Received August 15, 2019

    Report

    Report Number
    2242352-2019-00942
    Event Type
    Injury
    Date Received
    August 15, 2019
    Date of Event
    July 22, 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
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    INTERNAL COMPLAINT NUMBER: (B)(4). THE DEVICE WAS RETURNED TO THE FACTORY FOR EVALUATION. AN INVESTIGATION WAS CONDUCTED ON 09/11/2019. SIGNS OF CLINICAL USE AND EVIDENCE OF BLOOD WAS OBSERVED ON THE BASE OF THE JAWS. BLOOD AND CHARRED TISSUE WAS OBSERVED ON THE HEATER WIRE. THE HEATER WIRE WAS OBSERVED TO BE SLIGHTLY FLEXED AT THE MIDDLE OF THE HOT JAW TO THE TIP, BUT REMAINED ATTACHED AT THE BASE AND TIP. THE SILICONE INSULATION ON THE COLD JAW AT THE BASE OF THE JAW WAS OBSERVED TO BE PEELED AWAY FROM THE COLD JAW. THE PEELED 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.

    Additional Manufacturer Narrative · 0

    CORRECTED SECTION: H1-CHANGED TO SERIOUS INJURY. (B)(4).

    Description of Event or Problem · 0

    THE HOSPITAL REPORTED THAT DURING AN ENDOSCOPIC VEIN HARVESTING PROCEDURE USING VASOVIEWHEMPRO. JAWS CAME APART WHILE IN USE. THE CUSTOMER STATED THAT A SMALL PIECE DISLODGED FROM THE DEVICE WHILE IN THE PATIENT THEY WERE ABLE TO FLUSH IT OUT. PATIENT WAS TRANSFERRED TO THE ICU.

    Description of Event or Problem · 0

    THE HOSPITAL REPORTED THAT DURING AN ENDOSCOPIC VEIN HARVESTING PROCEDURE USING VASOVIEWHEMPRO. JAWS CAME APART WHILE IN USE. THE CUSTOMER STATED THAT A SMALL PIECE DISLODGED FROM THE DEVICE WHILE IN THE PATIENT THEY WERE ABLE TO FLUSH IT OUT. PATIENT WAS TRANSFERRED TO THE ICU.

    Additional Manufacturer Narrative · 1

    TRACKWISE # (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. A LOT HISTORY RECORD REVIEW WAS COMPLETED FOR THE REPORTED PRODUCT LOT NUMBER. THERE WERE NO NCMR¿S FOR THE REPORTED LOT NUMBER.

    Description of Event or Problem · 1

    THE HOSPITAL REPORTED THAT DURING AN ENDOSCOPIC VEIN HARVESTING PROCEDURE USING VASOVIEW HEMPRO. JAWS CAME APART WHILE IN USE. THE CUSTOMER STATED THAT A SMALL PIECE DISLODGED FROM THE DEVICE WHILE IN THE PATIENT THEY WERE ABLE TO FLUSH IT OUT. PATIENT WAS TRANSFERRED TO THE ICU.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    691637 EVH ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI MAQUET CARDIOVASCULAR LLC VASOVIEWHEMPRO (US) VH-3000 25146160

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention