BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3.5MM 90-S SERFAS ENERGY SUCTION PROBE

    MDR report key: 3143575 · Received June 3, 2013

    Report

    Report Number
    0002936485-2013-00245
    Event Type
    Malfunction
    Date Received
    June 3, 2013
    Date of Event
    May 13, 2013
    Report Date
    May 13, 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

    THE PRODUCT WAS RETURNED FOR INVESTIGATION. THE REPORTED FAILURE MODE WAS CONFIRMED. THE MISSING FLOWER SHAPED ELECTRODE PORTION WAS NOT RETURNED FOR EVALUATION. THE REST OF THE ELECTRODE WAS VISIBLE INSIDE THE CERAMIC TIP. SOME SCRATCH WEAR MARKS WERE OBSERVED ON THE LUMEN AND INSULATION. REVIEW OF THE DEVICE HISTORY RECORD OF THE REPORTED LOT NUMBER DISCLOSED NO DISCREPANCIES THAT COULD CONTRIBUTE TO THIS CONDITION. BASED ON THE RETURNED UNIT'S EVALUATION, THE MOST PROBABLE ROOT CAUSE IS DESIGN RELATED WITH A USER RELATED (MISUSE) POSSIBLE CONTRIBUTOR. IN SUM, THE PRODUCT WAS RETURNED FOR INVESTIGATION AND THE REPORTED FAILURE MODE WAS 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 PROBE DETACHED INTO THE PATIENT. THE DETACHED FRAGMENT WAS RETRIEVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PROCEDURE THE TIP OF THE PROBE DETACHED INTO THE PATIENT. THE DETACHED FRAGMENT WAS RETRIEVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    244708 3.5MM 90-S SERFAS ENERGY SUCTION PROBE ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI STRYKER ENDOSCOPY-SAN JOSE 13038AE2

    Patients

    Seq Age Sex Outcome Treatment
    1