BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SERFAS ENERGY SUPER 90-S

    MDR report key: 2957914 · Received February 12, 2013

    Report

    Report Number
    0002936485-2013-00026
    Event Type
    Malfunction
    Date Received
    February 12, 2013
    Date of Event
    January 31, 2013
    Report Date
    January 31, 2013
    Manufacturer
    STRYKER ENDOSCOPY-SAN JOSE
    Product Code
    GEI
    PMA / PMN Number
    K991960
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS RETURNED FOR INVESTIGATION. THE REPORTED TIP BREAKING WAS CONFIRMED. THE METAL ELECTRODE AND PART OF THE CERAMIC COMPONENT HAD BROKEN OFF FROM THE PROBE¿S TIP. THE BROKEN PARTS WERE ALSO RETURNED FOR EVALUATION. THERE WERE NO VISIBLE WEAR MARKS OR DAMAGE TO THE PROBE'S INSULATION. HOWEVER, SLIGHT SCRATCHES/MARKS COULD BE OBSERVED ON THE METAL LUMEN. THIS CONDITION IS A KNOWN FAILURE MODE AND THE PROBABLE ROOT CAUSES FOR THE REPORTED CONDITION CAN BE ASSOCIATED, BUT NOT LIMITED TO: NON-CONFORMING COMPONENT, POOR ASSEMBLY PROCESS, AND/OR 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.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED BY A COMPANY REPRESENTATIVE THAT DURING A PROCEDURE THE TIP OF THE UNIT BROKE OFF INSIDE THE PATIENT. THE TIP OF THE UNIT WAS RETRIEVED AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED BY A COMPANY REPRESENTATIVE THAT DURING A PROCEDURE THE TIP OF THE UNIT BROKE OFF INSIDE THE PATIENT. THE TIP OF THE UNIT WAS RETRIEVED AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    61685 SERFAS ENERGY SUPER 90-S ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI STRYKER ENDOSCOPY-SAN JOSE UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1