BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    5MM X 73MM CLEAR FLEXIBLE CANNULA THREADED

    MDR report key: 9450231 · Received December 11, 2019

    Report

    Report Number
    1017294-2019-00158
    Event Type
    Malfunction
    Date Received
    December 11, 2019
    Date of Event
    November 11, 2019
    Report Date
    December 11, 2019
    Manufacturer
    CONMED CORPORATION
    Product Code
    NBH
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AT TIME OF FILING, ALTHOUGH EXPECTED, THE REPORTED DEVICE HAS NOT BEEN RETURNED TO CONMED FOR EVALUATION. A SUPPLEMENTAL AND FINAL REPORT WILL BE FILED FOLLOWING THE COMPLETION OF THE DEVICE EVALUATION AND COMPLAINT INVESTIGATION. THIS ISSUE WILL CONTINUE TO BE MONITORED THROUGH THE COMPLAINT SYSTEM TO ASSURE PATIENT SAFETY.

    Description of Event or Problem · 1

    CONMED RECEIVED A REPORT FROM THE CUSTOMER DOCUMENTING ISSUES WITH THE .5MM X 73MM CLEAR FLEXIBLE CANNULA THREADED, ITEM # C7312, LOT 994150, THAT OCCURRED ON (B)(6) 2019 AT (B)(6) HOSPITAL IN (B)(6). IT WAS NOTED THAT "DURING ACROMIOPLASTY SURGERY, SEAL WAS DETACHED FROM A CANNULA AND LEFT INSIDE OF A PATIENT BODY IN THE MIDDLE OF INSERTING A SHAVER. AS SOON AS THE SURGEON FOUND IT, HE REMOVED THE LEFT SEAL USING A GRASPER FORCEPS. SURGERY WAS COMPLETED SUCCESSFULLY USING ANOTHER C7312 WITH A 5-MINUTE DELAY ". THE INFORMATION RECEIVED NOTED THE PATIENT WAS A (B)(6) FEMALE AND THERE WAS NO IMPACT OR INJURY TO HER. ALTHOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS MADE AVAILABLE. THIS REPORT IS BEING RAISED ON THE BASIS OF MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE (FRAGMENTATION FALLING IN THE PATIENT).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1248646 5MM X 73MM CLEAR FLEXIBLE CANNULA THREADED ACCESSORIES, ARTHROSCOPIC NBH CONMED CORPORATION 994150

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR