BEUDAMED
    FDA Adverse Event Injury Summary report: N

    3.5MM 90ÿ° SERFAS ENERGY PROBE

    MDR report key: 3242683 · Received July 23, 2013

    Report

    Report Number
    0002936485-2013-00303
    Event Type
    Injury
    Date Received
    July 23, 2013
    Date of Event
    May 26, 2013
    Report Date
    May 26, 2013
    Manufacturer
    STRYKER ENDOSCOPY-SAN JOSE
    Product Code
    GEI
    PMA / PMN Number
    K071859
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WILL BE PROVIDED ONCE INVESTIGATION HAS BEEN COMPLETED.

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS RETURNED FOR INVESTIGATION. THE REPORTED FAILURE MODE WAS CONFIRMED. VISUAL WEAR MARKS WERE OBSERVED ON THE LUMEN AND INSULATION. THE INSULATION WAS PULLED DOWN AND A SCRATCH MARK WAS OBSERVED RIGHT ON TOP AND BELOW IN THE INSULATION. THE DETACHED CERAMIC TIP AND ELECTRODE AND WERE NOT RETURNED. PROBABLE ROOT CAUSES FOR THE REPORTED CONDITION CAN BE ASSOCIATED, BUT ARE NOT LIMITED TO: DESIGN (STRENGTH) COMBINED WITH EXCESSIVE FORCE (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 THE PROCEDURE THE TIP BROKE INSIDE THE PATIENT'S FOOT. AN X-RAY WAS USED TO LOCATE AND EXTRACT THE TIP. THUS LEADING TO INCREASED PROCEDURE TIME AND EXPOSURE TO X-RAY DOSAGE. FURTHER, THE UNIT DID NOT SHOW ANY ERROR CODE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE PROCEDURE THE TIP BROKE INSIDE THE PATIENT'S FOOT. AN X-RAY WAS USED TO LOCATE AND EXTRACT THE TIP. THUS LEADING TO INCREASED PROCEDURE TIME AND EXPOSURE TO X-RAY DOSAGE. FURTHER, THE UNIT DID NOT SHOW ANY ERROR CODE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    344031 3.5MM 90ÿ° SERFAS ENERGY PROBE ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI STRYKER ENDOSCOPY-SAN JOSE 11319AE2

    Patients

    Seq Age Sex Outcome Treatment
    1