BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYSTEM 9735542 15W VISUALASE

    MDR report key: 6509131 · Received April 20, 2017

    Report

    Report Number
    1723170-2017-01727
    Event Type
    Malfunction
    Date Received
    April 20, 2017
    Date of Event
    March 22, 2017
    Report Date
    August 9, 2017
    Manufacturer
    MEDTRONIC NAVIGATION, INC. (LOUISVILLE)
    Product Code
    GEX
    UDI-DI
    00643169792890
    PMA / PMN Number
    K081656
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    NO PARTS HAVE BEEN RECEIVED BY THE MANUFACTURER FOR EVALUATION. PART NOT RETURNED FOR ANALYSIS.

    Additional Manufacturer Narrative · 1

    ON (B)(6) 2017, FURTHER REVIEW FOR SYSTEM PRODUCT NUMBER 142815, FOUND THAT THE REPORTED EVENT FOR THE CORE FIBER AND ADAPTOR CAP WOULD NOT MALFUNCTION INSIDE THE PATIENT ANATOMY AS THIS IS AN EXTERNAL PART (OUTSIDE OF PATIENT), AND THE REPORTED ISSUE WAS UNLIKELY TO CAUSE SERIOUS HARM. THE INITIAL MDR WAS SUBMITTED IN ERROR, AND THE REPORTED EVENT SHOULD NOT HAVE BEEN CONSIDERED A REPORTABLE MALFUNCTION.

    Description of Event or Problem · 1

    A MEDTRONIC REPRESENTATIVE REPORTED THAT, WHILE IN A LASER INDUCED THERMAL THERAPY PROCEDURE, THE COMPRESSION CAP ON THE DIFFUSING FIBER WOULD NOT TIGHTEN. THE ISSUE RESULTED IN A SALINE LEAKAGE FROM THE PUMP. THE SITE REMOVED THE FIBER AND REPLACED IT, ALLOWING THEM TO CONTINUE WITH THE ABLATION. NO ADDITIONAL INFORMATION WAS PROVIDED. THERE WAS A REPORTED DELAY TO THE PROCEDURE OF LESS THAN 1 HOUR DUE TO THIS ISSUE. THERE WAS NO IMPACT ON PATIENT OUTCOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    291397 SYSTEM 9735542 15W VISUALASE POWERED LASER SURGICAL INSTRUMENT GEX MEDTRONIC NAVIGATION, INC. (LOUISVILLE) 00643169792890

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR