BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DURABLE FLEXIBLE URETEROSCOPE

    MDR report key: 3001428 · Received March 7, 2013

    Report

    Report Number
    1218764-2013-00001
    Event Type
    Injury
    Date Received
    March 7, 2013
    Date of Event
    February 6, 2013
    Report Date
    February 6, 2013
    Manufacturer
    GYRUS ACMI, INC.
    Product Code
    FGB
    PMA / PMN Number
    K012925
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    AT THE TIME OF THIS REPORT, MULTIPLE ATTEMPTS TO OBTAIN FURTHER INFORMATION FROM THE HOSPITAL HAVE BEEN UNSUCCESSFUL, AND THE DEVICE HAS NOT YET BEEN RETURNED FOR EVAL. AS A RESULT, A DETERMINATION CANNOT BE MADE AT THIS TIME. IF FURTHER INFORMATION BECOMES AVAILABLE, GYRUS (B)(4) WILL CONTINUE THE INVESTIGATION AND UPDATE THE AGENCY ACCORDINGLY.

    Description of Event or Problem · 1

    AT SOME POINT THE DEFLECTION COVER HAD BEEN DAMAGED EITHER BY CLEANSING OR HANDLING. RATHER THAN DOING A REPAIR EXCHANGE PER THEIR CS CONTRACT, MERCY MEDICAL CENTER SENT IT OUT TO A THIRD PARTY TO HAVE THE DEFLECTION COVER REPLACED. UPON RETURN THE DUR-8ULTRA WAS STERILIZED IN NX AND TESTED BY THE BIO TECH WHO FOUND IT FUNCTIONAL AND ABLE TO FIT WITHIN AN ACCESS SHEATH. TYPE OF SHEATH USED WAS UNK. DURING THE LITHOTRIPSY URETEROSCOPY, THE DOCTOR USED A BOSTON SCIENTIFIC HOLUMUN LASER TO BREAK UP THE STONE. AFTER LASERING, WHEN THE DOCTOR REMOVED THE SCOPE FROM THE PT, IT WAS DISCOVERED THAT 90% OF THE DEFLECTION COVER WAS MISSING AND THE REMAINDER RESEMBLED WHAT WAS DESCRIBED AS A FLAKY SUBSTANCE. A LONER SCOPE WAS USED TO COMPLETE THE PROCEDURE. APPROX 2 HOURS WAS THEN SPENT ATTEMPTING TO REMOVE ALL THE FRAGMENTED DEFLECTION COVER PIECES FROM INSIDE THE PT. A STENT WAS ALSO PLACED IN THE PT TO ALLOW ANY LEFTOVER PIECES TO PASS. THERE WAS NO KNOWN OR REPORTED PHYSICAL DAMAGE TO THE PT DURING THE PROCEDURE ALTHOUGH IT IS UNK WHAT BIOLOGICAL REACTIONS THE PT MAY HAVE HAD TO ANY LEFTOVER PIECES OF THE DEFLECTION COVER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    97914 DURABLE FLEXIBLE URETEROSCOPE DURABLE FLEXIBLE URETEROSCOPE FGB GYRUS ACMI, INC. DUR-8ULTRA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other