BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNSPECIFIED INSTRUMENT

    MDR report key: 3853129 · Received April 2, 2014

    Report

    Report Number
    2523835-2014-00044
    Event Type
    Malfunction
    Date Received
    April 2, 2014
    Date of Event
    March 5, 2014
    Report Date
    March 6, 2014
    Manufacturer
    ALCON - IRVINE TECHNOLOGY CTR
    Product Code
    HQE
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION INCLUDING ROOT CAUSE ANALYSIS IS IN PROCESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WITH 21 CFT 803.56 WHEN ADDITIONAL REPORTABLE INFORMATION BECOMES AVAILABLE. (B)(4).

    Description of Event or Problem · 1

    A SURGEON REPORTED THAT THERE WAS POOR ACTUATION OF THE PROBE DURING A SURGICAL PROCEDURE. THE PROBE WAS EXCHANGED AND THE PROCEDURE WAS COMPLETED. THERE WAS NO HARM TO THE PATIENT. THE SURGEON REPORTED THAT THE PROBE HAD BEEN REUSED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    200008 UNSPECIFIED INSTRUMENT UNSPECIFIED INSTRUMENT HQE ALCON - IRVINE TECHNOLOGY CTR NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1