BEUDAMED
    FDA Adverse Event Injury Summary report: N

    5MM X 32CM STRYKEPROBE SPATULA TIP

    MDR report key: 3842497 · Received June 2, 2014

    Report

    Report Number
    0002936485-2014-00380
    Event Type
    Injury
    Date Received
    June 2, 2014
    Date of Event
    May 9, 2014
    Report Date
    May 9, 2014
    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

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

    Additional Manufacturer Narrative · 1

    THE REPORTED DEVICE WAS NOT RECEIVED FOR INVESTIGATION; THEREFORE, THE REPORTED FAILURE CANNOT BE CONFIRMED. THE COMPLAINT WILL BE CLOSED WITHOUT A DETAILED INVESTIGATION REPORT AND BASED ON PROBABLE ROOT CAUSE. IN THE EVENT THAT THE DEVICE IS RECEIVED, THE COMPLAINT WILL BE REOPENED, A FULL EVALUATION WILL BE CONDUCTED, AND THE INVESTIGATION WILL BE UPDATED WITH THE NEW RESULTS. PROBABLE ROOT CAUSE FOR THE REPORTED FAILURE INVOLVING THIS DEVICE COULD HAVE BEEN CAUSED BY: HEAT CONDUCTED BY DEVICE (EXCESSIVE RF ENERGY, ETC.). IN SUM, THE REPORTED FAILURE COULD NOT BE CONFIRMED SINCE THE DEVICE WAS NOT RECEIVED AT STRYKER ENDOSCOPY FOR INVESTIGATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ARC/SPARK WAS OBSERVED AT THE SHEATH AND THE COLON WAS BURNT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ARC/SPARK WAS OBSERVED AT THE SHEATH AND THE COLON WAS BURNT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    321724 5MM X 32CM STRYKEPROBE SPATULA TIP ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI STRYKER ENDOSCOPY-SAN JOSE NR

    Patients

    Seq Age Sex Outcome Treatment
    1