BEUDAMED
    FDA Adverse Event Other Summary report: N

    FLEXIBLE URETEROPYELOSCOPE KIT

    MDR report key: 1993318 · Received February 4, 2011

    Report

    Report Number
    1218764-2011-00001
    Event Type
    Other
    Date Received
    February 4, 2011
    Date of Event
    January 6, 2011
    Report Date
    February 4, 2011
    Manufacturer
    GYRUS ACMI, INC.
    Product Code
    FGB
    PMA / PMN Number
    K012925
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEFLECTION COVER WAS VISUALLY INSPECTED TO DETERMINE IF THERE WAS ANY MISSING OR DAMAGE PORTION OF THE DISTAL AND PROXIMAL BIOTHANE THAT WOULD ALLOW THE STRETCH OVER THE OBJECTIVE HEAD. BOTH BIOTHANE ARE COMPLETELY INTACT WITH NO INDICATION OF DAMAGED OR MISSING PORTIONS. THE COVER ALSO HAS THE PERMISSIBLE SLACK TO ALLOW DEFLECTION BUT NOT TO STRETCH OVER THE BIOTHANE. THE SCOPES IMAGE WAS VIEWED WITH AN ACMI MICRO DIGITAL IP CAMERA TO DETERMINE IF THERE WERE ANY BROKEN FIBERS, LENS SEPARATION OR OTHER IMAGE DISTORTIONS. THERE WERE NO DEFECTS OF THAT NATURE FOUND WITH THE IMAGE. THE ACCEPTABLE SPECIFICATIONS FOR DEFLECTION ANGULATION OF THE DUR-8 ARE 170 DEGREES/ 180 DEGREES IN THE UP ANGULATED POSITION AND 180 DEGREE/ 190 DEGREE IN THE DOWN ANGULATED POSITION, THE SCOPE PASSED BOTH SPECIFICATIONS. THE WORKING CHANNEL WAS INSPECTED FOR BLOCKAGE INSIDE OF THE CHANNEL. THIS WAS ACCOMPLISHED BY RUNNING A GUIDE WIRE DOWN THE LENGTH OF THE CHANNEL BEGINNING AT THE BIOPSY PORT CHANNEL AND ENDING THROUGH THE OBJECTIVE HEAD OPENING. THERE WAS NO OBSTRUCTION FOUND AS THE WIRE PASSED COMPLETELY THROUGH THE CHANNEL UNIMPEDED. THE SCOPE WAS LEAK TESTED TO DETERMINE IF THERE WERE ANY BROKEN OR MALFUNCTIONING SEALS ALLOWING MOISTURE INTO THE SCOPE THAT COULD POTENTIALLY DAMAGE THE DEFLECTION CABLES RESULTING IN THE REPORTED DEFLECTION FAILURE. THE SCOPE WAS ATTACHED TO A COMPRESSED AIR PUMP AND SUBMERGED UNDER WATER FOR 2 MINUTES. THE WORKING CHANNEL WAS PURGED OF EXCESS AIR AND NO LEAKS WERE FOUND DURING THE LEAK TEST. BASED UPON THE RESULTS OF THIS EVAL, THERE IS NO DEFINABLE DEFECT WITHIN THE GYRUS DUR-8 URETEROSCOPE SERIAL NUMBER (B)(4), AESTHETIC OR FUNCTIONAL, THAT COULD BE RELATED TO THE EVENT REPORTED. TO THE BEST OF OUR KNOWLEDGE THERE IS NO PROBLEM WITH THIS SCOPE THAT WOULD HAVE CONTRIBUTED TO THE REPORTED EVENT.

    Description of Event or Problem · 1

    DURING A SURGICAL PROCEDURE WHILE USING THE FLEXIBLE URETEROPYELOSCOPY, THE DEFLECTION FAILED WHEN INSIDE THE PT. THE BLACK RUBBER (BIOTHANE) CAME OFF, THE STONE GOT STUCK DURING SURGERY AND SCRATCHED PT'S URETER, NO ADDITIONAL HARM OR PROLONGED STAY FOR THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FLEXIBLE URETEROPYELOSCOPE KIT FLEXIBLE URETEROPYELOSCOPE KIT FGB GYRUS ACMI, INC. DUR-8

    Patients

    Seq Age Sex Outcome Treatment
    1