BEUDAMED
    FDA Adverse Event Injury Summary report: N

    5MM X 32CM STRYKEPROBE SPATULA TIP

    MDR report key: 2942799 · Received February 4, 2013

    Report

    Report Number
    0002936485-2013-00011
    Event Type
    Injury
    Date Received
    February 4, 2013
    Date of Event
    January 9, 2013
    Report Date
    January 11, 2013
    Manufacturer
    STRYKER ENDOSCOPY-SAN JOSE
    Product Code
    GEI
    PMA / PMN Number
    K963765
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS NOT RETURNED FOR INVESTIGATION. THE REPORTED FAILURE MODE COULD NOT BE CONFIRMED. BASED ON PAST COMPLAINTS INVOLVING THE SAME PART NUMBER AND SAME REPORTED FAILURE MODE HAVE BEEN PRIMARILY CAUSED BY: USE ERROR, IMPROPER STERILIZATION AND/OR NORMAL WEAR AND TEAR. HOWEVER, THIS CANNOT BE CONFIRMED UNTIL THE UNIT IS RETURNED FOR INVESTIGATION. IN THE EVENT THAT THE PRODUCT 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 PROVIDED ONCE THE INVESTIGATION HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RADIO FREQUENCY CURRENT WAS OBSERVED FROM THE INSULATION SHEATH. FURTHER, UNINTENDED TISSUE WAS BURNT. A BACKUP DEVICE WAS USED WITHOUT ANY OBSERVATIONS OF RADIO FREQUENCY CURRENT FROM THE INSULATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RADIO FREQUENCY CURRENT WAS OBSERVED FROM THE INSULATION SHEATH. FURTHER, UNINTENDED TISSUE WAS BURNT. A BACKUP DEVICE WAS USED WITHOUT ANY OBSERVATIONS OF RADIO FREQUENCY CURRENT FROM THE INSULATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    46300 5MM X 32CM STRYKEPROBE SPATULA TIP ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI STRYKER ENDOSCOPY-SAN JOSE 12C0067

    Patients

    Seq Age Sex Outcome Treatment
    1