BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SERIES TWENTY THOUSAND LEGACY

    MDR report key: 1022948 · Received March 28, 2008

    Report

    Report Number
    2028159-2008-00123
    Event Type
    Malfunction
    Date Received
    March 28, 2008
    Date of Event
    February 28, 2008
    Report Date
    February 28, 2008
    Manufacturer
    ALCON- IRVINE TECHNOLOGY CENTER
    Product Code
    HQE
    PMA / PMN Number
    K911808
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPANY SERVICE REP CALLED THE CUSTOMER TO REVIEW THE INCIDENT. THE CUSTOMER NOTED THEY SWITCHED OUT THE HANDPIECE. THE SYSTEM WAS WORKING OKAY, AND THEY DID NOT REQUEST SERVICE FOR THE SYSTEM. INVESTIGATION, INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADDITIONAL REPORTABLE INFO BECOMES AVAILABLE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT DURING A PROCEDURE, THE HANDPIECE WOULD NOT ASPIRATE AND THERE WAS NO POWER. THE SURGEON HAD A VERY DIFFICULT TIME ASPIRATING WITH THE HANDPIECE PROVIDED. THIS FIRST CASE WAS PARTICULARLY DIFFICULT TO FINISH AND THE CASE WAS PROLONGED BY AN HOUR. THE CUSTOMER DECLINED TO SEND IN THE HANDPIECE FOR EVALUATION. NO PT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SERIES TWENTY THOUSAND LEGACY OPHTHALMIC SURGERY SYSTEM HQE ALCON- IRVINE TECHNOLOGY CENTER STTL NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NI