BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3.5MM 90-S SERFAS ENERGY SUCTION PROBE

    MDR report key: 3140412 · Received May 31, 2013

    Report

    Report Number
    0002936485-2013-00239
    Event Type
    Malfunction
    Date Received
    May 31, 2013
    Date of Event
    April 30, 2013
    Report Date
    May 3, 2013
    Manufacturer
    STRYKER ENDOSCOPY-SAN JOSE
    Product Code
    GEI
    PMA / PMN Number
    K071859
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS RETURNED FOR INVESTIGATION. THE REPORTED FAILURE MODE WAS CONFIRMED. 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. BASED ON THE RETURNED UNIT'S EVALUATION, THE MOST PROBABLE ROOT CAUSE COULD BE DESIGN (STRENGTH) COMBINED WITH USER RELATED (MISUSE). THE WEAR MARKS ARE INDICATIVE OF FRICTION OR SCRAPPING WITH ANOTHER POINTY HARD OR RIGID OBJECT OR DEVICE DURING SURGERY (E.G. CUTTER OR SHAVER, HARD TISSUE OR BONE), POSSIBLY WHEN INSERTING OR REMOVING THE PROBE INTO AN OBSTRUCTED PASSAGEWAY. IT IS POSSIBLE THAT THE PROBE WAS USED AS A TOOL FOR THE MECHANICAL DISPLACEMENT OF TISSUE OR BONE, OR AS A PRYING OR SCRUBBING TOOL, WHICH MAY RESULT IN DAMAGE TO THE TIP. 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 DEVICE BROKE OFF INSIDE THE JOINT OF THE PATIENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PROCEDURE, THE TIP OF THE DEVICE BROKE OFF INSIDE THE JOINT OF THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    241647 3.5MM 90-S SERFAS ENERGY SUCTION PROBE ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI STRYKER ENDOSCOPY-SAN JOSE NA

    Patients

    Seq Age Sex Outcome Treatment
    1