BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLEXIBLE BIOPSY CUP 3FR 115CM

    MDR report key: 10645342 · Received October 7, 2020

    Report

    Report Number
    3003790304-2020-00100
    Event Type
    Malfunction
    Date Received
    October 7, 2020
    Report Date
    October 7, 2020
    Manufacturer
    LAKE REGION MEDICAL
    Product Code
    FCL
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER RETURNED A FBC-3115 (FLEXIBLE BIOPSY CUP 3FR 115CM) WITH LOT # 4923905 FOR EVALUATION. THE UNIT WAS RECEIVED WITHOUT THE ORIGINAL PACKAGING. A VISUAL INSPECTION WAS PERFORMED ON THE RECEIVED DEVICE AND FOUND NO VISUAL EVIDENCE OF DAMAGES ON THE COIL SHEATH, THE CUP WAS IN GOOD CONDITION; CUPS IN THE CLOSED POSITION WHEN RECEIVED. FOR TESTING, THE THUMB RING WAS ACTIVATED AND THE CUP WAS UNABLE TO CORRESPOND WHICH CONFIRMED THE USER¿S COMPLAINT. FURTHER EVALUATION WAS PERFORMED ON THE MOVEMENT OF THE THUMB RING AND OBSERVED THAT THE COIL SPRING AT THE DISTAL END OF THE HANDLE WAS STRETCHED. ALSO, ADHESIVE OF SOME KIND WAS NOTED ON THE COIL. THE THUMB RING WAS ACTIVATED AND THE INTERNAL COIL PIPE CAN VISUALLY BE OBSERVED LOOSELY EXTENDING OUT FROM THE OPENING AS A RESULT THE FORCEP CUPS WERE INOPERABLE. BASED ON THE EVALUATION, THE UNIT IS UN-OPERABLE DUE TO THE DAMAGE TO COIL SHEATH SECTION. THE INSTRUCTION MANUAL ON PAGE 5 IN THE ¿OPERATIONAL TEST¿ SECTION BULLET 2 STATES ¿USING THE HANDLE AND THUMB RING, OPEN AND CLOSE THE FORCEPS A FEW TIMES TO VERIFY SMOOTH OPERATION. ALWAYS OPERATE THE FORCEPS LIGHTLY, AS EXCESSIVE FORCE ON THUMB RING (EITHER PUSHING OR PULLING) CAN CAUSE DETERIORATION AND BREAKAGE¿.

    Description of Event or Problem · 1

    THE SERVICE CENTER WAS INFORMED THAT DURING PREPARATION FOR USE, THE CUPS OF TWO FORCEPS WERE NO LONGER OPENING. THE FACILITY REPORTED THAT THE FORCEPS WERE USED LESS THAN A YEAR. THERE WAS NO PATIENT INVOLVEMENT REPORTED. THIS IS 2 OF 2 REPORTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1106302 FLEXIBLE BIOPSY CUP 3FR 115CM FLEXIBLE BIOPSY CUP 3FR 115CM FCL LAKE REGION MEDICAL FBC-3115 4923905

    Patients

    Seq Age Sex Outcome Treatment
    1