BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3.5MM 90-S SERFAS ENERGY SUCTION PROBE

    MDR report key: 3143540 · Received June 3, 2013

    Report

    Report Number
    0002936485-2013-00243
    Event Type
    Malfunction
    Date Received
    June 3, 2013
    Date of Event
    May 8, 2013
    Report Date
    May 9, 2013
    Manufacturer
    STRYKER ENDOSCOPY-SAN JOSE
    Product Code
    GEI
    PMA / PMN Number
    K071859
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS RETURNED FOR INVESTIGATION. THE REPORTED FAILURE MODE WAS CONFIRMED. THE MISSING FLOWER SHAPED ELECTRODE PORTION WAS RETURNED FOR EVALUATION. THE REST OF THE ELECTRODE WAS VISIBLE INSIDE THE CERAMIC TIP. TISSUE RESIDUE WAS OBSERVED ON THE ELECTRODE AND THE CERAMIC. SCRATCH WEAR MARKS WERE OBSERVED ON ALL OF THE CERAMIC AND LUMEN. NO VISUAL WEAR MARKS WERE OBSERVED ON THE PROBE¿S INSULATION. REVIEW OF THE DEVICE HISTORY RECORD OF THE REPORTED LOT NUMBER WAS REVIEWED. THE REVIEW DISCLOSED NO DISCREPANCIES THAT COULD CONTRIBUTE TO THIS CONDITION. THE MOST PROBABLE ROOT CAUSE IS DESIGN RELATED WITH A USER RELATED (MISUSE) POSSIBLE CONTRIBUTOR FACTOR. 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 THE PROCEDURE THE WAND OF THE UNIT BROKE INSIDE OF THE PATIENT. A FIVE MINUTE DELAY WAS REPORTED AND ALLEGEDLY THERE WAS HARM TO THE PATIENT WITH NO ADVERSE CONSEQUENCE. IT WAS FURTHER REPORTED THAT THE TIP WAS RETRIEVED FROM THE PATIENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE PROCEDURE THE WAND OF THE UNIT BROKE INSIDE OF THE PATIENT. A FIVE MINUTE DELAY WAS REPORTED AND ALLEGEDLY THERE WAS HARM TO THE PATIENT WITH NO ADVERSE CONSEQUENCE. IT WAS FURTHER REPORTED THAT THE TIP WAS RETRIEVED FROM THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    245071 3.5MM 90-S SERFAS ENERGY SUCTION PROBE ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI STRYKER ENDOSCOPY-SAN JOSE 12205AE2

    Patients

    Seq Age Sex Outcome Treatment
    1