BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLEARVISION II, LENS IRRIGATION UNIT

    MDR report key: 6220495 · Received January 3, 2017

    Report

    Report Number
    9610617-2017-00001
    Event Type
    Malfunction
    Date Received
    January 3, 2017
    Date of Event
    November 30, 2016
    Report Date
    November 30, 2016
    Manufacturer
    KARL STORZ GMBH & CO. KG TUTTLINGEN, GERMANY
    Product Code
    EJT
    PMA / PMN Number
    K012838
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS EVALUATED AND WE WERE UNABLE TO DUPLICATE THE ISSUE. THE UNIT WAS TESTED FOR ABOUT TWO HOURS, UNIT WAS WORKING PROPERLY (NEVER STOPPED WORKING). UNIT PASSED ALL FUNCTIONAL, SAFETY TEST. WE RECOMMENDED THAT THE ACCOUNT SEND IN THEIR FOOTSWITCH FOR EVALUATION TO SEE IF THAT DEVICE WAS THE CAUSE OF THE ALARMS.

    Description of Event or Problem · 1

    ALLEGEDLY, DURING A NUERO PROCEDURE A LOUD ALARM SOUNDED MULTIPLE TIMES AND THE DOCTOR ALSO NOTED THAT THE PUMP STOPPED IRRIGATING. THE DOCTOR IMMEDIATELY REPLACED IT WITH A MANUAL PUMP AND THE DOCTOR WENT ON TO COMPLETE THE PROCEDURE. THE HOSPITAL REPORTED THAT THERE WAS NO INJURY TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2370 CLEARVISION II, LENS IRRIGATION UNIT LENS IRRIGATION UNIT EJT KARL STORZ GMBH & CO. KG TUTTLINGEN, GERMANY 40334120

    Patients

    Seq Age Sex Outcome Treatment
    1