BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SUCTION TUBE, 2.7MM LH FRONTAL SINUS

    MDR report key: 4120928 · Received September 26, 2014

    Report

    Report Number
    0001811755-2014-03373
    Event Type
    Malfunction
    Date Received
    September 26, 2014
    Date of Event
    August 28, 2014
    Report Date
    August 29, 2014
    Manufacturer
    STRYKER INSTRUMENTS-KALAMAZOO
    Product Code
    HAW
    PMA / PMN Number
    K002732
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION IN PROGRESS.

    Additional Manufacturer Narrative · 1

    DURING FAILURE ANALYSIS, THE REPORTED EVENT THAT THE TIP WAS BROKEN OFF WAS CONFIRMED THROUGH THE VISUAL INSPECTION. IT IS POSSIBLE ROUGH OR IMPROPER HANDLING LED TO THE BROKEN TIP. THE DEVICE WAS DISCARDED BY THE MANUFACTURER FOLLOWING EVALUATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE TIP BROKE OFF OF THE SUCTION TUBE, 2.7MM LH FRONTAL SINUS DURING INSPECTION AT THE USER FACILITY. NO PATIENT INVOLVEMENT, NO ADVERSE CONSEQUENCES, NO MEDICAL INTERVENTION, AND NO SURGICAL DELAY WERE REPORTED WITH THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE TIP BROKE OFF OF THE SUCTION TUBE, 2.7MM LH FRONTAL SINUS DURING INSPECTION AT THE USER FACILITY. NO PATIENT INVOLVEMENT, NO ADVERSE CONSEQUENCES, NO MEDICAL INTERVENTION, AND NO SURGICAL DELAY WERE REPORTED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    601820 SUCTION TUBE, 2.7MM LH FRONTAL SINUS NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW STRYKER INSTRUMENTS-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1