BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VASOVIEW HEMOPRO 2 WITH VASOSHIELD

    MDR report key: 6135832 · Received November 30, 2016

    Report

    Report Number
    2242352-2016-01217
    Event Type
    Malfunction
    Date Received
    November 30, 2016
    Date of Event
    November 2, 2016
    Report Date
    November 3, 2016
    Manufacturer
    MAQUET CV
    Product Code
    GEI
    PMA / PMN Number
    K101274
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RETURNED TO THE FACTORY FOR EVALUATION. SIGNS OF CLINICAL USE AND EVIDENCE OF BLOOD WERE OBSERVED. A VISUAL INSPECTION DETERMINED THAT THE HEATER WIRE WAS SLIGHTLY FLEXED AWAY AT THE CENTER FROM THE HOT JAW. THE WIRE REMAINED IN PLACE AT THE BASE AND TIP OF THE JAWS. TISSUE AND CHAR BUILDUP WAS OBSERVED ON THE JAWS. BASED ON THE RETURNED CONDITION OF THE DEVICE THE COMPLAINT WAS CONFIRMED FOR REPORTED FAILURE MODE ¿BENT WIRE.¿ SPECIFIC ACTIONS FOR THE REPORTED FAILURE MODE ARE BEING MAINTAINED AND DOCUMENTED UNDER MAQUET'S FAILURE INVESTIGATION REPORT (FIR) SYSTEM.

    Additional Manufacturer Narrative · 1

    (B)(4). A LOT HISTORY RECORD REVIEW WAS COMPLETED FOR THE REPORTED PRODUCT LOT NUMBER. THERE WAS NO NONCONFORMANCE RECORDED IN THE LOT HISTORY. 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 2 WITH VASOSHIELD METAL PART OF ONE SIDE OF THE JAWS BENT. A REPLACEMENT DEVICE WAS USED TO COMPLETE THE PROCEDURE. THE HOSPITAL DID NOT REPORT ANY PATIENT EFFECTS.

    Description of Event or Problem · 1

    THE HOSPITAL REPORTED THAT DURING AN ENDOSCOPIC VEIN HARVESTING PROCEDURE, VASOVIEW HEMOPRO 2 WITH VASOSHIELD METAL PART OF ONE SIDE OF THE JAWS BENT. 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
    787720 VASOVIEW HEMOPRO 2 WITH VASOSHIELD ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI MAQUET CV 25128289

    Patients

    Seq Age Sex Outcome Treatment
    1