BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SERFAS ENERGY SUPER 90-S

    MDR report key: 3831302 · Received May 24, 2014

    Report

    Report Number
    0002936485-2014-00359
    Event Type
    Malfunction
    Date Received
    May 24, 2014
    Date of Event
    April 25, 2014
    Report Date
    April 30, 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

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    THE TIP BREAKING CONDITION (ELECTRODE) WAS CONFIRMED ON THE RETURNED UNIT. THE DETACHED ELECTRODE WAS RETURNED WITH THE UNIT. ACCORDING TO THE WEAR MARKS, IT IS POSSIBLE THAT THE UNIT WAS USED AS A TOOL FOR THE MECHANICAL DISPLACEMENT OF TISSUE OR BONE, OR USE THE PROBE AS A PRYING OR SCRUBBING TOOL, OR THAT EXCESSIVE FORCE WAS USED WHEN INSERTING OR REMOVING THE PROBE INTO AN OBSTRUCTED PASSAGEWAY, THIS MAY RESULT IN DAMAGE TO THE TIP OF THE PROBE. AS SUCH, THE MOST PROBABLE ROOT CAUSE IS 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 TIP HAS BROKEN OFF.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE TIP HAS BROKEN OFF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    309676 SERFAS ENERGY SUPER 90-S ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI STRYKER ENDOSCOPY-SAN JOSE 14044AE2

    Patients

    Seq Age Sex Outcome Treatment
    1