BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    5MM X 32CM STRYKEPROBE L-TIP

    MDR report key: 3221516 · Received July 11, 2013

    Report

    Report Number
    0002936485-2013-00288
    Event Type
    Malfunction
    Date Received
    July 11, 2013
    Date of Event
    June 18, 2013
    Report Date
    June 18, 2013
    Manufacturer
    STRYKER ENDOSCOPY-SAN JOSE
    Product Code
    GEI
    PMA / PMN Number
    K963765
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS NOT RETURNED FOR INVESTIGATION. THE REPORTED FAILURE MODE COULD NOT BE CONFIRMED. THE POSSIBLE ROOT CAUSES FOR THE REPORTED FAILURE CAN BE DUE TO: USE ERROR, IMPROPER STERILIZATION, NORMAL WEAR AND TEAR AND/OR INSULATION FAILURE. HOWEVER, THIS CANNOT BE CONFIRMED SINCE THE UNIT WAS NOT RETURNED. IN THE EVENT THAT THE UNIT IS RETURNED, A FULL EVALUATION WILL BE CONDUCTED AND A FOLLOW UP REPORT WILL BE ISSUED. IN SUM, THE PRODUCT WAS NOT RETURNED FOR INVESTIGATION AND THE REPORTED FAILURE MODE COULD NOT BE CONFIRMED. THE FAILURE MODE WILL BE MONITORED FOR FUTURE REOCCURRENCE.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WILL BE PROVIDE ONCE INVESTIGATION HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SHEATH MELTED DURING CAUTERY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SHEATH MELTED DURING CAUTERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    319975 5MM X 32CM STRYKEPROBE L-TIP ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI STRYKER ENDOSCOPY-SAN JOSE UNK

    Patients

    Seq Age Sex Outcome Treatment
    1