BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SERIES 20000 LEGACY

    MDR report key: 3130312 · Received May 22, 2013

    Report

    Report Number
    2028159-2013-00955
    Event Type
    Malfunction
    Date Received
    May 22, 2013
    Date of Event
    April 12, 2013
    Report Date
    April 25, 2013
    Manufacturer
    ALCON - IRVINE TECHNOLOGY CENTER
    Product Code
    HQC
    PMA / PMN Number
    K911808
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER'S COMPLAINT HISTORY WAS REVIEWED FOR THE PERIOD OF ONE YEAR; THIS IS THE FIRST COMPLAINT REPORTED FOR THIS ISSUE. THE FINISHED GOODS LOT SPECIFIC TO THIS EVENT IS NOT KNOWN; THEREFORE, LOT HISTORY AND DHR (DEVICE HISTORY RECORD) REVIEW WAS NOT POSSIBLE. THE ROOT CAUSE OF THE CUSTOMER'S COMPLAINT IS NOT KNOWN; A SAMPLE WAS NOT RETURNED FOR INVESTIGATION. WITHOUT A SAMPLE, A ROOT CAUSE CANNOT BE DETERMINED. MANUFACTURING PROCEDURE REQUIRES THE MACHINE OPERATOR TO INSPECT BAGS FOR ISSUE WITH THE SEAL, TAPE, OR PUNCH HOLES, IRREGULARITIES, ETC EVERY 10 MINUTES OR 36 DRAIN BAGS/HOUR. (B)(4).

    Description of Event or Problem · 1

    A SURGEON REPORTED THAT THERE WAS LEAKAGE FROM THE DRAIN BAG DURING A PROCEDURE. AFTER THE PACK WAS EXCHANGED, THE CASE WAS ABLE TO BE COMPLETED WITHOUT IMPACT TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    226816 SERIES 20000 LEGACY PHACOFRAGMENTATION SYSTEM HQC ALCON - IRVINE TECHNOLOGY CENTER STTL NA

    Patients

    Seq Age Sex Outcome Treatment
    1 MICROTIP MAXVAC TIPLESS PAK