BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCURUS 400VS

    MDR report key: 2080129 · Received April 7, 2011

    Report

    Report Number
    2028159-2011-00328
    Event Type
    Malfunction
    Date Received
    April 7, 2011
    Report Date
    March 8, 2011
    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
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPANY REP EXAMINED THE SYSTEM AND COULD NOT DUPLICATE THE PROBLEM REPORTED. NO SYSTEM MESSAGES WERE FOUND IN THE EVENT LOG. THE SYSTEM WAS THEN TESTED AND MET ALL PRODUCT SPECIFICATIONS. THE ROOT CAUSE IS UNK. (B)(4).

    Description of Event or Problem · 1

    A NURSE MANAGER REPORTED THAT THERE WAS NO VACUUM IN EXTRUSION MODE. MULTIPLE ATTEMPTS HAVE BEEN MADE TO GATHER INFO REGARDING PT IMPACT AND CURRENT STATUS, BUT NO INFO HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCURUS 400VS PHACOFRAGMENTATION SYSTEM HQC ALCON - IRVINE TECHNOLOGY CENTER ACCURUS NA

    Patients

    Seq Age Sex Outcome Treatment
    1