BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCURUS 800CS

    MDR report key: 3960021 · Received May 29, 2014

    Report

    Report Number
    2028159-2014-00918
    Event Type
    Malfunction
    Date Received
    May 29, 2014
    Report Date
    April 24, 2014
    Manufacturer
    ALCON - IRVINE TECHNOLOGY CTR
    Product Code
    HQC
    PMA / PMN Number
    K911808
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    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. ADDITIONAL INFO HAS BEEN REQUESTED BUT NOT RECEIVED TO DATE. (B)(4). THIS REPORT WAS MAILED TO FDA ON: 05/23/2014. (B)(4).

    Description of Event or Problem · 1

    A NURSE REPORTED THAT AT THE BEGINNING OF A VITRECTOMY SURGERY, THE CUTTER OF THE VITREOTOME DID NOT MOVE AND BLOCKED THE SUCTION. THE VITREOTOME HAD TO BE EXCHANGED TO COMPLETE THE SURGERY. IN SURGEON'S OPINION, THE DEFECT COULD NOT BE NOTICED BEFORE THE SURGERY. THE PT DID NOT EXPERIENCE ANY HARM. ADDITIONAL INFO HAS BEEN REQUESTED BUT NOT RECEIVED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    315891 ACCURUS 800CS PHACOFRAGMENTATION SYS HQC ALCON - IRVINE TECHNOLOGY CTR ACCURUS NA

    Patients

    Seq Age Sex Outcome Treatment
    1 CP 23GA PRB 0.9| TOTAL PLUS| PAK