BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MVE CONSOLE, 120V, 60HZ

    MDR report key: 2471880 · Received February 27, 2012

    Report

    Report Number
    1920664-2012-00029
    Event Type
    Injury
    Date Received
    February 27, 2012
    Date of Event
    January 25, 2012
    Report Date
    January 31, 2012
    Manufacturer
    BAUSCH & LOMB, INC.
    Product Code
    HQE
    PMA / PMN Number
    K020911
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE USER FACILITY QUARANTINED THE MILLENNIUM UNIT AS WELL AS THE "BACKUP SYSTEM". ON AN UNSPECIFIED DATE, IT WAS REPORTED THAT THE USER FACILITY HAD A THIRD PARTY SERVICE REVIEW THE EQUIPMENT. "NO PROBLEMS" WERE FOUND WITH THE FUNCTION OF THE MILLENNIUM OR THE MVE CONSOLE. AT THIS TIME, THE USER FACILITY HAS NOT INDICATED WHETHER THEY INTEND TO RELEASE THE DEVICE TO BAUSCH AND LOMB FOR EVALUATION. A SUPPLEMENTAL REPORT WILL BE FILED SHOULD THE DEVICE BECOME AVAILABLE FOR INVESTIGATION.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED, A RESIDENT WAS PERFORMING SURGERY UNDER SUPERVISION OF ANOTHER SURGEON. THE SURGEON TRIED TO ACTIVATE THE CUTTER USING THE FOOT PEDAL; HOWEVER, THE CUTTING ACTION DID NOT FUNCTION. THE VITRECTOMY CUTTER HAD PREVIOUSLY BEEN FUNCTIONING CORRECTLY BUT STOPPED CUTTING WHILE IT WAS IN THE EYE. ASPIRATION CONTINUED AND TRACTION ON THE VITREOUS CAUSED A RETINAL TEAR. THE PROCEDURE WAS ABORTED AND THE PT WAS TAKEN TO ANOTHER FACILITY FOR FURTHER TREATMENT. THOUGH REQUESTED, NO ADDITIONAL INFO WAS RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MVE CONSOLE, 120V, 60HZ NONE HQE BAUSCH & LOMB, INC. CX6900

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention