BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VASOVIEW HEMOPRO 2

    MDR report key: 15591441 · Received October 12, 2022

    Report

    Report Number
    2242352-2022-00847
    Event Type
    Malfunction
    Date Received
    October 12, 2022
    Date of Event
    September 20, 2022
    Report Date
    October 20, 2022
    Manufacturer
    MAQUET CARDIOVASCULAR LLC
    Product Code
    GEI
    UDI-DI
    00607567700406
    PMA / PMN Number
    K101274
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    TRACKWISE ID (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.

    Additional Manufacturer Narrative · 0

    TRACKWISE #(B)(4) UPDATED SECTION: B4, G4, G7, H2, H3, H6, H10 THE DEVICE WAS RETURNED TO THE FACTORY FOR EVALUATION ON (B)(6) 2022. AN INVESTIGATION WAS CONDUCTED ON 10/17/2022. A VISUAL INSPECTION WAS CONDUCTED. SIGNS OF CLINICAL USE AND EVIDENCE OF BLOOD WERE OBSERVED ON THE HARVESTING DEVICE HANDLE, JAWS, AND HEATER WIRE. EVIDENCE OF CHARRED TISSUE WAS ALSO OBSERVED ON THE HEATER WIRE. A MICROSCOPIC INSPECTION WAS CONDUCTED. THE CLEAR SILICONE INSULATION OF THE COLD JAW WAS OBSERVED TO PEELED AT THE TOP OF THE JAW, EXPOSING THE METAL TIP OF THE JAW. THE INSULATION OF THE HOT JAW AND THE HEATER WIRE WERE OBSERVED TO BE INTACT WITH NO VISUAL DEFECTS OBSERVED. BASED ON THE RETURNED CONDITION OF THE DEVICE AS WELL AS THE INVESTIGATION RESULTS, THE REPORTED FAILURE "MATERIAL TWISTED/ BENT" WAS NOT CONFIRMED. HOWEVER, THE ANALYZED FAILURE, "PEELED; JAW" WAS CONFIRMED. THE LOT HISTORY RECORD REVIEW WAS COMPLETED. THERE WERE NCMRS , REWORK, OR DEVIATIONS DOCUMENTED FOR THE REPORTED LOT NUMBER. NCMR #(B)(6)- A NOTIFICATION WAS RECEIVED FROM GXO THAT 1 OUT OF 500 UNITS WAS FOUND DAMAGED DURING THE INBOUND INSPECTION FOR MATERIAL # VH-4000 BATCH # 3000258449. GXO NCMR REF#: (B)(4). BASED ON THE DHR/LHR REVIEW RESULTS, IT WAS DETERMINED THAT THERE IS NO RELATION BETWEEN THE BATCH MANUFACTURING PROCESS AND THE REPORTED FAILURE.

    Description of Event or Problem · 0

    THE HOSPITAL REPORTED THAT DURING AN ENDOSCOPIC VEIN HARVESTING PROCEDURE, VASOVIEW HEMOPRO 2 MALFUNCTIONED. THE JAWS OF THE INSTRUMENT CAME APART (LIKE FILLETED APART), BUT DID NOT DETACH INTO THE HARVESTING TUNNEL /INSIDE THE PATIENT. A REPLACEMENT DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT HARM OR DAMAGE DONE.

    Description of Event or Problem · 0

    N/A

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2601827 VASOVIEW HEMOPRO 2 ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI MAQUET CARDIOVASCULAR LLC VASOVIEW HEMOPRO 2 3000258449 00607567700406

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Female