BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BARD PLATINUM PLATINUM CLASS URETEROSCOPIC 3

    MDR report key: 2772210 · Received October 2, 2012

    Report

    Report Number
    1018233-2012-01437
    Event Type
    Malfunction
    Date Received
    October 2, 2012
    Report Date
    September 5, 2012
    Manufacturer
    OMNITECH SYSTEMS, INC.
    Product Code
    FFL
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SAMPLE WAS RECEIVED AND THE BREAK WAS CLEAN AND ALL PIECES OF THE SHEATH APPEAR TO BE PRESENT. VISUAL EXAMINATION NOTED THAT THE ACTUAL BASKET WAS INTACT WITH NO SIGNS OF DAMAGE. NO OBVIOUS MANUFACTURING DEFECTS OR OTHER CONDITIONS WERE FOUND THAT WOULD HAVE CONTRIBUTED TO THE BROKEN SHEATH. A REVIEW OF THE DEVICE HISTORY RECORDS FOR THE REPORTED LOT NUMBER DID NOT SHOW ANY PROBLEMS OR CONDITIONS THAT COULD HAVE CONTRIBUTED TO THE REPORTED ISSUE. THE INSTRUCTIONS FOR USE WHICH ACCOMPANIES ALL DEVICES CURRENTLY ADDRESSES POTENTIAL RISKS ASSOCIATED WITH SURGICALLY IMPLANTED MATERIALS. THE LABELING AND INSTRUCTIONS FOR USE STATES: ¿CAUTIONS: OBJECTS THAT ARE TOO LARGE TO BE RECOVERED THROUGH THE SHEATH OR THROUGH THE SCOPE CHANNEL WILL REQUIRE THE SCOPE AND BASKET TO BE REMOVED SIMULTANEOUSLY FROM THE URINARY TRACT. IF RESISTANCE IS ENCOUNTERED DURING ADVANCEMENT OR WITHDRAWAL OF THE DEVICE, STOP AND DETERMINE THE SOURCE OF RESISTANCE, AS CONTINUED RESISTANCE MAY DAMAGE THE DEVICE AND COULD RESULT IN PATIENT INJURY. TAKE ACTION TO ALLEVIATE THE RESISTANCE. WHERE NECESSARY, USE OF A LITHOTRITE MAY BE REQUIRED TO REDUCE THE STONE BURDEN WITHIN THE BASKET, PROVIDED THAT NO DIRECT CONTACT IS MADE WITH THE STONE BASKET. PRECAUTIONS: DO NOT ALLOW THE DEVICE TO COME IN CONTACT WITH ANY ELECTRICAL EQUIPMENT. DO NOT ROTATE AN OPEN BASKET IN THE URETER. POTENTIAL COMPLICATIONS THAT MAY RESULT FROM THE USE OF A BASKET IN AN ENDOSCOPIC UROLOGICAL PROCEDURE INCLUDE BUT ARE NOT LIMITED TO: PERFORATION, EDEMA, EVULSION, ENTRAPMENT, BASKET INVERSION, INABILITY TO DISENGAGE FROM, HEMORRHAGE IRRETRIEVABLE OBJECT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BASKET TIP BROKE OFF IN THE PATIENT. THE TIP WAS REMOVED DURING THE PROCEDURE USING GRASPING FORCEPS THROUGH THE INITIALLY PLACED SCOPE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BARD PLATINUM PLATINUM CLASS URETEROSCOPIC 3 FFL OMNITECH SYSTEMS, INC. NA BMVKM029

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention