BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WHITESTAR SIGNATURE SYSTEM

    MDR report key: 2081249 · Received April 26, 2011

    Report

    Report Number
    2020664-2011-00021
    Event Type
    Injury
    Date Received
    April 26, 2011
    Date of Event
    March 29, 2011
    Report Date
    March 29, 2011
    Manufacturer
    ABBOTT MEDICAL OPTICS (AMO)
    Product Code
    HQC
    PMA / PMN Number
    K060366
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PHACOEMULSIFICATION MACHINE AND VITRECTOMY HAND PIECE WERE EXAMINED AND TESTED. THE MACHINE WAS EVALUATED BY AN AMO SERVICE TECHNICIAN AT THE CUSTOMER'S LOCATION. THE TECHNICIAN VERIFIED THE OPERATION AND CALIBRATION OF THE PNEUMATIC VITRECTOMY ASSEMBLY. DURING INSPECTION OF THE MACHINE, THE TECHNICIAN FOUND THE SURGEON'S VITRECTOMY SETTINGS ON THE FOOT PEDAL WERE PROGRAMMED TO WORK FROM THE SIDE VITRECTOMY (USING THE LEFT SIDE SWITCH) WHICH DETERMINES HOW THE VITRECTOMY CUTTER IS ACTIVATED. THE TECHNICIAN FOUND THE VITRECTOMY FEATURE WAS WORKING PROPERLY. THERE WERE NO ISSUES DETECTED WITH THE OPERATION OF THE MACHINE OR THE VITRECTOMY CUTTER HAND PIECE. THE MACHINE WAS FOUND TO MEET AMO SPECIFICATIONS. THROUGH FOLLOW UP, THE CLINIC INDICATED THE VITRECTOMY NOT ACTIVATED WAS USER ERROR. THE TECHNICIAN WAS NOT ABLE TO IDENTIFY AN EXPLANATION FOR THE POSTERIOR CAPSULE TEAR. THE SYSTEM IS CONTINUING TO BE USED WITHOUT FURTHER REPORTED INCIDENTS. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Description of Event or Problem · 1

    THE CLINIC EXPERIENCED A POSTERIOR CAPSULAR TEAR RESULTING IN AN UNPLANNED VITRECTOMY IN THE PATIENT'S OPERATIVE EYE DURING CATARACT EXTRACTION PROCEDURE. DURING THE VITRECTOMY PROCEDURE, THE VITRECTOMY MODE WOULD NOT ACTIVATE. THE CLINIC ATTEMPTED TO USE THREE VITRECTOMY HANDPIECES AND WAS UNSUCCESSFUL IN ACTIVATING THE VITRECTOMY FEATURE. THE CLINIC USED A BACK UP MACHINE TO COMPLETE THE PROCEDURE. THE CLINIC INDICATED THE PATIENT HAD A MATURE CATARACT THAT MAY HAVE CAUSED THE POSTERIOR CAPSULAR TEAR. THE PATIENT HAD A GOOD SURGICAL OUTCOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 WHITESTAR SIGNATURE SYSTEM HQC ABBOTT MEDICAL OPTICS (AMO) NGP680300

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention