BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WHITESTAR SIGNATURE¿ SYSTEM

    MDR report key: 3304089 · Received August 22, 2013

    Report

    Report Number
    2020664-2013-00094
    Event Type
    Injury
    Date Received
    August 22, 2013
    Date of Event
    July 26, 2013
    Report Date
    July 26, 2013
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    HQC
    PMA / PMN Number
    K060366
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER TECHNICAL SUPPORT INSTRUCTED THE CUSTOMER ON THE CORRECT PREPARATION OF THE VITRECTOMY HAND PIECE. REMAINED ON THE LINE PRIOR TO USE AND CONFIRMED SUCCESS. THE SYSTEM WILL NOT BE CHECKED AS THE CALLER REPORTED THE UNPLANNED VITRECTOMY WAS REQUIRED DUE TO PATIENT NOR THE SIGNATURE PHACO SYSTEM. (B)(4): PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    DEVICE AVAILABLE FOR EVALUATION: YES. DEVICE MANUFACTURE DATE: 09/30/2011. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS HAS BEEN SUBMITTED. PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS AT THE TIME OF THIS REPORT HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    CUSTOMER CALLED TO REPORT SHE HAD DIFFICULTY PREPPING THE VITRECTOMY HANDPIECE. SHE STATED THE VITRECTOMY WAS UNPLANNED, BUT NOT AS A RESULT OF A SYSTEM PROBLEM. SHE SAID THE VITRECTOMY WAS DUE TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    409141 WHITESTAR SIGNATURE¿ SYSTEM SIGNATURE HQC ABBOTT MEDICAL OPTICS NGP680300

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention