BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOVEREIGN SYSTEM

    MDR report key: 1052192 · Received May 20, 2008

    Report

    Report Number
    2020664-2008-00016
    Event Type
    Malfunction
    Date Received
    May 20, 2008
    Date of Event
    April 21, 2008
    Report Date
    April 21, 2008
    Manufacturer
    ADVANCED MEDICAL OPTICS (AMO)
    Product Code
    HQC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DURING A PHACOEMULSIFICATION PROCEDURE, THE DOCTOR REPORTED THAT THE FOOTPEDAL STOPPED WORKING AND WAS NOT ABLE TO BE RESTARTED. THE CLINIC DID NOT HAVE A BACK UP FOOTPEDAL. A FOOTPEDAL WAS LOCATED AT ANOTHER FACILITY AND INSTALLED WITH THE MACHINE, AND THE CASES WERE CONTINUED. THIS EVENT RESULTED IN AN APPROX 2 HOUR DELAY OF SURGERY FOR ONE CASE; HOWEVER, THERE WERE NO ADVERSE EFFECTS TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SOVEREIGN SYSTEM PHACOEMULSIFICATION SYSTEM HQC ADVANCED MEDICAL OPTICS (AMO) SOV680300 NA

    Patients

    Seq Age Sex Outcome Treatment
    1