BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    APOLLO GENERATOR

    MDR report key: 4839120 · Received June 11, 2015

    Report

    Report Number
    3005168196-2015-00584
    Event Type
    Malfunction
    Date Received
    June 11, 2015
    Date of Event
    May 2, 2015
    Report Date
    May 12, 2015
    Manufacturer
    PENUMBRA, INC.
    Product Code
    GWG
    PMA / PMN Number
    K152699
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    RESULT: THE APOLLO SYSTEM BLUE FOOT PEDAL BUTTON WAS NO LONGER ATTACHED TO THE FOOT PEDAL. CONCLUSION: THE COMPLAINT HAS BEEN EVALUATED. THE COMPLAINT INDICATED THAT THE BLUE SALINE FLUSH BUTTON ON THE APOLLO SYSTEM GENERATOR FOOT PEDAL WAS BROKEN. EVALUATION OF THE RETURNED PRODUCT REVEALED THAT THE BLUE BUTTON ON THE FOOT PEDAL WAS NO LONGER ATTACHED. SINCE THE BUTTON WAS NOT RETURNED FOR EVALUATION, THE FAILURE MODE IS UNKNOWN. THERE IS NO EVIDENCE OF A DEVICE MALFUNCTION. SUPPLIER QUALITY HAS BEEN NOTIFIED. THE MANUFACTURING RECORDS FOR THIS LOT WERE REVIEWED AND DID NOT REVEAL ANY OUTSTANDING DISCREPANCIES, DESIGN, OR QUALITY CONCERNS.

    Additional Manufacturer Narrative · 1

    PMA/510K: K152699. DEVICE MFR DATE: 6/30/2014.

    Additional Manufacturer Narrative · 1

    (B)(4)

    Description of Event or Problem · 1

    THE PATIENT WAS UNDERGOING A MICRONEUROSURGERY PROCEDURE USING AN APOLLO SYSTEM GENERATOR FOOT PEDAL. WHILE PREPARING THE DEVICES, THE PHYSICIAN NOTICED THE BLUE BUTTON TO FLUSH THE APOLLO WAND WAS MISSING. THE PHYSICIAN WAS STILL ABLE TO USE THE FOOT PEDAL, BUT IT REQUIRED MORE PRESSURE FOR ACTIVATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    382747 APOLLO GENERATOR GWG GWG PENUMBRA, INC. F60214

    Patients

    Seq Age Sex Outcome Treatment
    1