BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    4.0MM 90-S MAX SERFAS ENERGY SUCTION PROBE

    MDR report key: 3790963 · Received May 5, 2014

    Report

    Report Number
    0002936485-2014-00304
    Event Type
    Malfunction
    Date Received
    May 5, 2014
    Date of Event
    April 9, 2014
    Report Date
    April 9, 2014
    Manufacturer
    STRYKER ENDOSCOPY-SAN JOSE
    Product Code
    GEI
    PMA / PMN Number
    K071859
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS RETURNED FOR INVESTIGATION AND THE REPORTED FAILURE MODE WAS CONFIRMED. AFTER PERFORMING THE VISUAL INSPECTION ON THE RETURNED UNIT, SCRATCH WEAR MARKS WERE OBSERVED ON THE LUMEN AND INSULATION CONCENTRATED TOWARD THE FRONTAL RIGHT SIDE OF THE PROBE, ELECTRODE FACING FORWARD. THE INSULATION HAS A PORTION WITH CHARRED APPEARANCE AND IT HAS A COUPLE OF IMPACT WEAR MARKS BELOW THE CHARRED PORTION. A PORTION OF THE LUMEN IS EXPOSED (INSULATION TORN). NO SCRATCH MARKS OR ANY INSULATION DAMAGE ARE OBSERVED ON THE LEFT SIDE OR THE BACK OF THE PROBE. THE SCRATCH WEAR MARKS ARE INDICATIVE OF POSSIBLE USE OF THE UNIT AS A TOOL FOR THE MECHANICAL DISPLACEMENT OF TISSUE OR BONE, FRICTION OR SCRAPPING WITH ANOTHER HARD 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 WHICH CAN BE IDENTIFIED AS A POSSIBLE CONTRIBUTOR FOR THE REPORTED INSULATION DAMAGED. THE PROBABLE ROOT CAUSES FOR THE REPORTED CONDITION CAN BE ASSOCIATED TO MISUSE. 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 THE INSULATION ON AN 90-S MAX MELTED APPROXIMATELY ONE INCH FROM THE DISTAL TIP. A SECOND DEVICE WAS OPENED AND DID THE SAME THING.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE INSULATION ON AN 90-S MAX MELTED APPROXIMATELY ONE INCH FROM THE DISTAL TIP. A SECOND DEVICE WAS OPENED AND DID THE SAME THING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    266660 4.0MM 90-S MAX SERFAS ENERGY SUCTION PROBE ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI STRYKER ENDOSCOPY-SAN JOSE 14028AE2

    Patients

    Seq Age Sex Outcome Treatment
    1