BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DIGITAL URETEROSCOPE (STANDARD)

    MDR report key: 3747124 · Received April 12, 2014

    Report

    Report Number
    0002936485-2014-00223
    Event Type
    Injury
    Date Received
    April 12, 2014
    Date of Event
    March 21, 2014
    Report Date
    March 21, 2014
    Manufacturer
    STRYKER ENDOSCOPY-SAN JOSE
    Product Code
    FGB
    PMA / PMN Number
    K121112
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    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: CHIPPING/PEELING OF OTHER COMPONENTS, COMPONENTS FROM SCOPE TIP FALLING OFF, GLUE DEGRADATION. IN SUM, THE REPORTED FAILURE COULD NOT BE CONFIRMED SINCE THE DEVICE WAS NOT RECEIVED AT STRYKER ENDOSCOPY FOR INVESTIGATION.

    Additional Manufacturer Narrative · 1

    PRODUCT WAS RECEIVED AT STRYKER ENDOSCOPY. THE UNIT WAS THEN SENT TO VSI FOR A FULL INVESTIGATION. THE CUSTOMER'S COMPLAINT OF THE INSERTION TUBE BEING DAMAGED HAS BEEN CONFIRMED. DURING THE ESTIMATION IT WAS FOUND THAT THE LIGHT GUIDE FIBERS, ANGLE SECTION AND ANGLE WIRES ARE BROKEN. THE SCOPE HAS NO IMAGE AND THE CHANNEL IS LEAKING. REPLACEMENTS INCLUDE THE FINAL INSERTION TUBE, FERRULE, ADAPTOR, SEALING CAP AND VENT CAP. PROBABLE ROOT CAUSE: TRAUMATIC HANDLING. 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 THAT DURING A TRIAL THE URETER RUPTURED WHEN BEING TAKEN OUT OF THE PATIENT. THE ORIGINAL PROCEDURE WAS NOT COMPLETED AS REPAIRING THE DAMAGE HAD TO BE DONE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A TRIAL THE URETER RUPTURED WHEN BEING TAKEN OUT OF THE PATIENT. THE ORIGINAL PROCEDURE WAS NOT COMPLETED AS REPAIRING THE DAMAGE HAD TO BE DONE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A TRIAL THE URETER RUPTURED WHEN BEING TAKEN OUT OF THE PATIENT. THE ORIGINAL PROCEDURE WAS NOT COMPLETED AS REPAIRING THE DAMAGE HAD TO BE DONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    225972 DIGITAL URETEROSCOPE (STANDARD) URETEROSCOPE AND ACCESSORIES, FLEXIBLE/RIGID FGB STRYKER ENDOSCOPY-SAN JOSE

    Patients

    Seq Age Sex Outcome Treatment
    1