BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCURUS 400VS

    MDR report key: 2982953 · Received February 26, 2013

    Report

    Report Number
    2028159-2013-00305
    Event Type
    Malfunction
    Date Received
    February 26, 2013
    Date of Event
    January 30, 2013
    Report Date
    January 30, 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
    BR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPANY REP EXAMINED THE SYSTEM AND WAS ABLE TO REPLICATE THE REPORTED EVENT UPON SYSTEM STARTUP THE TRANSDUCER PRINTER CIRCUIT BOARD (PCB) WAS REPLACED. THE SYSTEM WAS THEN TESTED AND MET ALL PRODUCT SPECIFICATIONS. NO SAMPLE IS COMING BACK AS THE CUSTOMER KEPT THE REPLACED PART. THERE WAS NO SAMPLE RETURNED FOR EVAL AND NO ADD'L INFO PROVIDED RELATED TO THIS EVENT. FOR THIS REASON, STEPS COULD NOT BE TAKEN TO REPLICATE OR CONFIRM THE REPORTED EVENT. A REVIEW OF COMPLAINTS FOR THE LAST (B)(4) DID NOT INDICATE ANY ADD'L SIMILAR REPORTS FOR THIS SYSTEM. THE ROOT CAUSE WAS DETERMINED TO BE A NONCONFORMING TRANSDUCER PCB. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER REPORTED THE EQUIPMENT DISPLAYED A SYSTEM MESSAGE AND LOCKED PRIOR TO THE PROCEDURE. THE PROCEDURE WAS CANCELLED AFTER THE PT HAD REC'D PERIBULBAR ANESTHESIA. THERE WAS NO HARM TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    81777 ACCURUS 400VS PHACOFRAGMENTATION SYSTEM HQC ALCON - IRVINE TECHNOLOGY CENTER ACCURUS NA

    Patients

    Seq Age Sex Outcome Treatment
    1