BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOSCOPE, URETEROSCOPE, COBRA

    MDR report key: 3063766 · Received March 28, 2013

    Report

    Report Number
    1418479-2013-00005
    Event Type
    Malfunction
    Date Received
    March 28, 2013
    Report Date
    October 16, 2012
    Manufacturer
    RICHARD WOLF MEDICAL INSTRUMENTS CORP.
    Product Code
    KNS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE RECEIVED ON (B)(4) 2012 FOR INVESTIGATION. PRODUCT APPEARED TO BE USED. UPON VISUAL AND FUNCTIONAL TESTING, WITH A MICROSCOPE AND LEAK TESTER, HOLES WERE FOUND IN THE DISTAL HOSE AND INSERTION TUBE. THIS ALLOWED MOISTURE TO PENETRATE INSIDE OF SHAFT AND MAY HAVE CAUSED WIRE TO CORRODE AND BREAK. ROOT CAUSE IS HANDLING OF THE DEVICES. UNABLE TO DETERMINE WHAT IS MAKING THE HOLES. NOT A MFG ISSUE. SALES REP REPORTED NO INJURIES TO PT OR STAFF. NO SIMILAR COMPLAINTS ON THIS SPECIFIC PRODUCT OR LOT IN THE LAST THREE YRS. LABELING WAS REVIEWED AND FOUND TO BE ADEQUATE. I.E. INTENDED USE, INDICATIONS AND FIELD OF USE, PREPARATION AND CAUTIONS. (B)(4) CONSIDERS THIS MATTER CLOSED. HOWEVER, IN THE EVENT WE RECEIVE THE DEVICE OR ADDITIONAL INFO IS RECEIVED, WE WILL PROVIDE FDA WITH F/U INFO.

    Description of Event or Problem · 1

    DURING PROCEDURE, DOCTOR HEARD A SNAP AND THE DEFLECTION STOPPED WORKING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    129387 ENDOSCOPE, URETEROSCOPE, COBRA FLEXIBLE URETEROSCOPE KNS RICHARD WOLF MEDICAL INSTRUMENTS CORP. 7326.071 613618

    Patients

    Seq Age Sex Outcome Treatment
    1 Other