BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3.5MM 90-S SERFAS ENERGY SUCTION PROBE

    MDR report key: 3133280 · Received May 29, 2013

    Report

    Report Number
    0002936485-2013-00231
    Event Type
    Malfunction
    Date Received
    May 29, 2013
    Date of Event
    April 29, 2013
    Report Date
    April 30, 2013
    Manufacturer
    STRYKER ENDOSCOPY-SAN JOSE
    Product Code
    GEI
    PMA / PMN Number
    K071859
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    UPON VISUAL INSPECTION OF THE RETURNED UNIT, THE REPORTED CONDITION WAS CONFIRMED TO BE RELATED TO TIP BREAKAGE. THE METAL ELECTRODE HAD BROKEN OFF FROM THE PROBE¿S DISTAL END. PRONOUNCED MARKS AND DAMAGE WAS OBSERVED ON THE BLACK INSULATION. IN ADDITION, THE PROBE¿S WAND WAS NOTABLY BENT. THE CERAMIC TIP ALSO PRESENTED SOME SCRAPE MARKS. THE UNIT WAS CONNECTED TO AN ENERGY CONSOLE. A P2 ERROR CODE WAS OBSERVED. A P2 ERROR CORRESPONDS TO A "PROBE EXPIRED ERROR" - THE TIME SINCE THE FIRST ACTIVATIONS 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. REVIEW OF THE DEVICE HISTORY RECORD OF THE SUBJECT PART AND LOT NUMBER DISCLOSED NO MANUFACTURING ISSUES THAT COULD BE RELATED TO THE REPORTED FAILURE CONDITION. PROBABLE ROOT CAUSES FOR THE REPORTED CONDITION CAN BE ASSOCIATED, BUT NOT LIMITED TO: COMPONENT ISSUE, IMPROPER ASSEMBLY 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. THE TIP WAS REMOVED FROM THE PATIENT AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A 5 MINUTE DELAY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PROCEDURE, THE TIP OF THE DEVICE BROKE OFF. THE TIP WAS REMOVED FROM THE PATIENT AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A 5 MINUTE DELAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    236660 3.5MM 90-S SERFAS ENERGY SUCTION PROBE ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI STRYKER ENDOSCOPY-SAN JOSE UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1