BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    APOLLO SYSTEM APOLLO WAND

    MDR report key: 3889439 · Received June 23, 2014

    Report

    Report Number
    3005168196-2014-00425
    Event Type
    Malfunction
    Date Received
    June 23, 2014
    Date of Event
    May 24, 2014
    Report Date
    May 24, 2014
    Manufacturer
    PENUMBRA, INC.
    Product Code
    GWG
    PMA / PMN Number
    K132931
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    RESULT: MATERIAL WAS MELTED WHERE THE DOWEL PIN IS LOCATED. A LEAK WAS OBSERVED DURING FUNCTIONAL TEST. CONCLUSION: THE COMPLAINT HAS BEEN EVALUATED. THE COMPLAINT INDICATES THAT AFTER SIX MINUTES OF WORKING TIME A SMALL STREAM OF SPRAYING SALINE WAS NOTICED BETWEEN THE CONNECTION OF THE BLACK PLASTIC OF THE DISPOSABLE WAND AND THE WHITE CONNECTION TO THE APOLLO MACHINE. EVALUATION OF THE RETURNED DEVICE CONFIRMED A LEAK WHEN THE UNIT WAS POWERED ON. IT APPEARS THAT EXCESSIVE HEAT WAS GENERATED DURING USE, WHICH CAUSED THE ABS MATERIAL TO MELT AND ALLOW THE DOWEL PIN TO SHIFT. THIS RESULTED IN A LEAK WHERE THE DOWEL PIN IS LOCATED. THE ROOT CAUSE OF THE EXCESSIVE HEAT EXPERIENCED BY THE UNIT HAS NOT BEEN DETERMINED. THIS ISSUE WILL CONTINUE TO BE MONITORED. THE MANUFACTURING RECORDS FOR THIS LOT WERE REVIEWED AND DID NOT REVEAL ANY OUTSTANDING DISCREPANCIES, DESIGN, OR QUALITY CONCERNS.

    Description of Event or Problem · 1

    THE PATIENT WAS UNDERGOING MICRONEUROSURGERY PROCEDURE USING THE APOLLO SYSTEM APOLLO WAND. DURING THE PROCEDURE, A LEAK DEVELOPED AT THE CONNECTION OF THE BLACK PLASTIC OF THE DISPOSABLE APOLLO WAND AND THE WHITE CONNECTION ON THE APOLLO MACHINE. AFTER IT WAS NOTICED, THE PHYSICIAN STOPPED THE PROCEDURE AND USED A NEW WAND. THE PROCEDURE WAS COMPLETED AND THERE WAS NO REPORT OF AN ADVERSE EFFECT ON THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    364947 APOLLO SYSTEM APOLLO WAND GWG GWG PENUMBRA, INC. F41939

    Patients

    Seq Age Sex Outcome Treatment
    1