BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOVEREIGN COMPACT CONSOLE

    MDR report key: 3250588 · Received July 26, 2013

    Report

    Report Number
    2020664-2013-00047
    Event Type
    Injury
    Date Received
    July 26, 2013
    Date of Event
    June 26, 2013
    Report Date
    June 26, 2013
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    HQC
    PMA / PMN Number
    K060366
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CORRECTED DATA: IS THIS A SINGLE USE DEVICE THAT WAS REPROCESSED AND REUSED ON A PATIENT: NO. DEVICE AVAILABLE FOR EVALUATION: YES. REPORT SOURCE: FOREIGN, HEALTH PROFESSIONAL. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS HAS BEEN SUBMITTED. PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    (B)(4). ACCOUNT REPORTED THERE WAS NO PATIENT INJURY HOWEVER, THERE WAS A SIGNIFICANT DELAY IN COMPLETING THE PROCEDURE. A FIELD SERVICE ENGINEER (FSE) VISITED ACCOUNT AND WAS ABLE TO REPLICATED THE ISSUE AS REPORTED. INSPECTION REVEALED SUBSYSTEM BOARD WAS CAUSING THE ERROR MESSAGE. SUBSYSTEM BOARD WAS REPLACED AND FSE CONFIRMED THE MACHINE MET AMO SPECIFICATIONS. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS AT THE TIME OF THIS REPORT HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS AT THIS TIME HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    CUSTOMER CALLED TO REPORT THAT SOVEREIGN COMPACT HAD A FOOTPEDAL ERROR WHILE ULTRASOUND WAS BEING APPLIED DURING A SURGERY. THE CUSTOMER REPLACED THE FOOTPEDAL WITH ANOTHER, AND THE SYSTEM SEEMED TO WORK FOR A WHILE; HOWEVER, THE SAME ERROR OCCURRED. THEN, THE CUSTOMER USED A SECONDARY UNIT (ANOTHER SOVEREIGN COMPACT) AND THE SURGERY WAS SUCCESSFULLY COMPLETED. NO PATIENT INJURY REPORTED. SURGERY WAS DELAYED AT LEAST 20 MINUTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    350089 SOVEREIGN COMPACT CONSOLE SOVEREIGN COMPACT HQC ABBOTT MEDICAL OPTICS CMP680300

    Patients

    Seq Age Sex Outcome Treatment
    1 Other