BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SERFAS ENERGY SUPER 90-S

    MDR report key: 3831301 · Received May 24, 2014

    Report

    Report Number
    0002936485-2014-00356
    Event Type
    Malfunction
    Date Received
    May 24, 2014
    Date of Event
    April 18, 2014
    Report Date
    April 29, 2014
    Manufacturer
    STRYKER ENDOSCOPY-SAN JOSE
    Product Code
    GEI
    PMA / PMN Number
    K071859
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHARMACIST

    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 WHERE THE REPORTED TIP BREAKAGE WAS CONFIRMED. THE RETURNED UNIT WAS VISUALLY INSPECTED WITHOUT MAGNIFICATION, WHICH REVEALED THAT THE ELECTRODE WAS MISSING. THE DETACHED ELECTRODE WAS RETURNED FOR EVALUATION. VISUAL INSPECTION ALSO FOUND SCRATCH MARKS ON THE LUMEN AND INSULATION RIGHT BELOW THE ELECTRODE INDICATIVE OF SCRAPPING WITH ANOTHER OBJECT OR BONE. THE UNIT WAS CONNECTED TO A SERFAS ENERGY CONSOLE TO TEST FUNCTIONALITY, BUT WAS UNABLE TO DO SO. THIS IS BECAUSE OR AN P2 ERROR WHICH WILL OCCUR 24 HOURS AFTER INITIAL USE OF THE DEVICE. THE PROBABLE ROOT CAUSES FOR THE REPORTED CONDITION CAN BE ASSOCIATED, BUT ARE NOT LIMITED 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 DURING A SHOULDER ARTHROSCOPY THE TIP OF THE PROBE FRACTURED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A SHOULDER ARTHROSCOPY THE TIP OF THE PROBE FRACTURED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    309651 SERFAS ENERGY SUPER 90-S ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI STRYKER ENDOSCOPY-SAN JOSE 14020AE2

    Patients

    Seq Age Sex Outcome Treatment
    1