BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3.5MM 90-S SERFAS ENERGY SUCTION PROBE

    MDR report key: 3041540 · Received April 8, 2013

    Report

    Report Number
    0002936485-2013-00125
    Event Type
    Malfunction
    Date Received
    April 8, 2013
    Date of Event
    March 6, 2013
    Report Date
    March 15, 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
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED TIP BREAKAGE FAILURE MODE WAS CONFIRMED ON THE RETURNED DEVICE. THE MISSING FLOWER SHAPED ELECTRODE PORTION WAS RETURNED FOR EVALUATION. THE REST OF THE ELECTRODE WAS VISIBLE INSIDE THE CERAMIC TIP. SOME VISUAL WEAR MARKS WERE OBSERVED ON THE CERAMIC, LUMEN AND INSULATION. REVIEW OF THE DEVICE HISTORY RECORD (DHR) OF THIS LOT DISCLOSED NO DISCREPANCIES THAT COULD CONTRIBUTE TO THIS CONDITION. THE PROBABLE ROOT CAUSES FOR THE REPORTED CONDITION CAN BE ASSOCIATED, BUT ARE NOT LIMITED TO: NON CONFORMING COMPONENTS, POOR ASSEMBLY PROCESS, AND/OR MISUSE. IN SUM, THE PRODUCT WAS RETURNED FOR INVESTIGATION AND THE REPORTED FAILURE MODE COULD BE CONFIRMED. THE FAILURE MODE WILL BE MONITORED FOR FUTURE REOCCURRENCE.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PROCEDURE, THE TIP OF THE DEVICE DETACHED. IT WAS FURTHER REPORTED THAT THE FRAGMENT WAS RETRIEVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PROCEDURE, THE TIP OF THE DEVICE DETACHED. IT WAS FURTHER REPORTED THAT THE FRAGMENT WAS RETRIEVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    143959 3.5MM 90-S SERFAS ENERGY SUCTION PROBE ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI STRYKER ENDOSCOPY-SAN JOSE 13009AE2

    Patients

    Seq Age Sex Outcome Treatment
    1