BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    5MM MONOPOLAR HANDLE 33CM

    MDR report key: 3933541 · Received July 15, 2014

    Report

    Report Number
    0002936485-2014-00497
    Event Type
    Malfunction
    Date Received
    July 15, 2014
    Date of Event
    June 10, 2014
    Report Date
    June 20, 2014
    Manufacturer
    STRYKER ENDOSCOPY-SAN JOSE
    Product Code
    KOG
    PMA / PMN Number
    K973259
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CI
    Reporter Occupation
    NURSE

    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: INCORRECT STERILIZATION/REPROCESSING PROCEDURE; HANDLING PROCEDURES; CONTACT FORCES; PRODUCT USED BEYOND DEFINED USEFUL LIFE. 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 DEVICE LOST THE TEFLON INSULATION AFTER STERILIZATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE LOST THE TEFLON INSULATION AFTER STERILIZATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    413763 5MM MONOPOLAR HANDLE 33CM ENDOSCOPE AND/OR ACCESSORIES KOG STRYKER ENDOSCOPY-SAN JOSE 0943591D 1146710D S/L

    Patients

    Seq Age Sex Outcome Treatment
    1