BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    4.0MM 90-S MAX SERFAS ENERGY SUCTION PROBE

    MDR report key: 3063762 · Received April 17, 2013

    Report

    Report Number
    0002936485-2013-00151
    Event Type
    Malfunction
    Date Received
    April 17, 2013
    Date of Event
    March 26, 2013
    Report Date
    March 26, 2013
    Manufacturer
    STRYKER ENDOSCOPY-SAN JOSE
    Product Code
    GEI
    PMA / PMN Number
    K071859
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WILL BE PROVIDED ONCE THE INVESTIGATION HAS BEEN COMPLETED.

    Additional Manufacturer Narrative · 1

    THE REPORTED TIP BREAKING (METAL ELECTRODE) WAS CONFIRMED ON THE RETURNED UNIT. A PIECE OF THE CERAMIC TOGETHER WITH THE ELECTRODE TIP WAS DETACHED. THE DETACHED PIECE OF THE ELECTRODE WAS RETURNED WITH THE UNIT. HOWEVER, THE MISSING CERAMIC PIECE WAS NOT RETURNED. EXAMINATION UNDER MAGNIFICATION (ABOUT 100 X) CONFIRMED THE PRESENCE OF WEAR MARKS ON THE LUMEN CONCENTRATED BELOW THE ELECTRODE AND CERAMIC AS WELL AS ON THE INSULATION. THE WEAR MARKS ON THE LUMEN SEEM TO BE SCRATCH MARKS WITH A POINTY OBJECT, HOWEVER THE WEAR MARKS ON THE INSULATION APPEAR TO BE MORE IMPACT OR PRESSURE RELATED. IN ADDITION, THE WAND WAS BENT. FUNCTIONAL INSPECTION REVEALED A P2 ERROR CODE WHEN CONNECTED TO AN ENERGY CONSOLE. A P2 ERROR CORRESPONDS TO A "PROBE EXPIRED ERROR" - THE TIME SINCE THE FIRST ACTIVATION OF THE CURRENT PROBE HAS EXCEEDED 24 HOURS. A P2 ERROR CODE IS EXPECTED (NORMAL) TO BE OBTAINED WHEN CONNECTING THE PROBE AFTER 24 HOURS OF BEING ACTIVATED FOR THE FIRST TIME. DEVICE HISTORY RECORD OF THE REPORTED PRODUCT/LOT NUMBER WAS REVIEWED. THERE WERE NO MANUFACTURING RELATED DISCREPANCIES OBSERVED THAT COULD CONTRIBUTE OR BE RELATED TO THIS CONDITION. PROBABLE ROOT CAUSES FOR THE REPORTED CONDITION CAN BE ASSOCIATED, BUT NOT LIMITED TO: NON-CONFORMING COMPONENT, ASSEMBLY PROCESS, AND/OR MISUSE. IN SUM, THE PRODUCT WAS RETURNED FOR INVESTIGATION AND THE REPORTED FAILURE MODE WAS CONFIRMED. THE FAILURE MODE WILL BE MONITORED FOR FUTURE REOCCURRENCE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PROCEDURE, THE TIP OF THE DEVICE BROKE OFF INSIDE THE PATIENT AND WAS ABLE TO BE RETRIEVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PROCEDURE, THE TIP OF THE DEVICE BROKE OFF INSIDE THE PATIENT AND WAS ABLE TO BE RETRIEVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    164713 4.0MM 90-S MAX SERFAS ENERGY SUCTION PROBE ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI STRYKER ENDOSCOPY-SAN JOSE 13030AE2

    Patients

    Seq Age Sex Outcome Treatment
    1