BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SERFAS ENERGY SUPER 90-S

    MDR report key: 3041560 · Received April 8, 2013

    Report

    Report Number
    0002936485-2013-00126
    Event Type
    Malfunction
    Date Received
    April 8, 2013
    Date of Event
    March 5, 2013
    Report Date
    March 18, 2013
    Manufacturer
    STRYKER ENDOSCOPY-SAN JOSE
    Product Code
    GEI
    PMA / PMN Number
    K071859
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    NURSING ASSISTANT

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    THE REPORTED TIP BREAKAGE CONDITION WAS CONFIRMED ON THE RETURNED UNIT. THE CERAMIC TIP AND ELECTRODE HAD BROKEN OFF FROM THE PROBE¿S DISTAL END. THE METAL ELECTRODE PIECE WAS NOT RETURNED. THERE WERE VISIBLE SCRATCH MARKS ON THE PRODUCT'S CERAMIC TIP, AND THE HEAT-SHRINK (BLACK INSULATION) PRESENTED SOME DAMAGE. SIGNIFICANT DAMAGE (TORN / PEELED) AND DENTS WERE OBSERVED ON THE BLACK INSULATION DISTAL END. SOME SCRATCH MARKS COULD ALSO BE OBSERVED ON THE EXPOSED AREA OF THE LUMEN. 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 FRACTURED AND THE FRAGMENT WAS LOST IN THE PATIENT. IT WAS LATER REPORTED THAT THE FRAGMENT WAS SUCCESSFULLY RETRIEVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PROCEDURE, THE TIP OF THE DEVICE FRACTURED AND THE FRAGMENT WAS LOST IN THE PATIENT. IT WAS LATER REPORTED THAT THE FRAGMENT WAS SUCCESSFULLY RETRIEVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    144074 SERFAS ENERGY SUPER 90-S ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI STRYKER ENDOSCOPY-SAN JOSE 12352AE2

    Patients

    Seq Age Sex Outcome Treatment
    1