BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MALLEABLE SUCTION MEDIUM, STANDARD TIP

    MDR report key: 4111236 · Received September 23, 2014

    Report

    Report Number
    1723170-2014-01013
    Event Type
    Malfunction
    Date Received
    September 23, 2014
    Date of Event
    August 25, 2013
    Report Date
    August 25, 2013
    Manufacturer
    MEDTRONIC NAVIGATION, INC.
    Product Code
    PGW
    PMA / PMN Number
    K133665
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    RMA ISSUED. REPLACEMENT MALLEABLE SUCTION SHIPPED TO SITE (B)(4) 2014. MEDTRONIC INVESTIGATION OF RETURNED SUSPECT MALLEABLE SUCTION FINDS THAT THE TOOL SHOWS RED STATUS WITH ERROR "POOR SIGNAL" IN THE SYSTEM ACCURACY TEST. THE SUCTION TOOL WILL NOT NAVIGATE. DIAGNOSTICS IN THE CRANIAL APPLICATION SHOW ONLY 2 OF 3 COILS ARE SENDING DATA. ELECTRICAL FAILURE - DIRECTLY CAUSED EVENT.

    Description of Event or Problem · 1

    A MEDTRONIC ENT REPRESENTATIVE REPORTED THAT, WHILE IN A FUNCTIONAL ENDOSCOPIC SINUS SURGERY (FESS), A MALLEABLE SUCTION UNEXPECTEDLY STOPPED TRACKING. THIS OCCURRED AT APPROXIMATELY 25 MINUTES INTO THE PROCEDURE, PREVIOUSLY THE INSTRUMENT WORKED PROPERLY. TROUBLE-SHOOTING DID NOT RESOLVE THE ISSUE. THE SURGEON OPTED TO USE AN ALTERNATE INSTRUMENT, A FRAZIER STRAIGHT SUCTION, TO CONTINUE AND COMPLETED THE PROCEDURE WITH THE USE OF THE NAVIGATION SYSTEM. THERE WAS NO IMPACT ON PATIENT OUTCOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    590132 MALLEABLE SUCTION MEDIUM, STANDARD TIP EAR, NOSE, AND THROAT STEREOTAXIC INSTRUMENT PGW MEDTRONIC NAVIGATION, INC. 140530J

    Patients

    Seq Age Sex Outcome Treatment
    1