BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CORE DYNAMICS

    MDR report key: 19655339 · Received July 2, 2024

    Report

    Report Number
    1320894-2024-00169
    Event Type
    Malfunction
    Date Received
    July 2, 2024
    Date of Event
    June 13, 2024
    Report Date
    August 13, 2024
    Manufacturer
    CONMED UTICA
    Product Code
    FBM
    UDI-DI
    10653405045861
    PMA / PMN Number
    K911813
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE IS NOT EXPECTED TO BE RETURNED FOR EVALUATION AND REVIEW. HOWEVER, THE COMPLAINT INVESTIGATION IS NOT COMPLETE AT THIS TIME. A SUPPLEMENTAL AND FINAL REPORT WILL BE FILED FOLLOWING THE COMPLETION OF THE COMPLAINT INVESTIGATION. WE WILL CONTINUE TO MONITOR FOR TRENDS THROUGH THE COMPLAINT SYSTEM TO ASSURE PATIENT SAFETY.

    Additional Manufacturer Narrative · 0

    D1 BRAND NAME WAS UPDATED FROM ENII 5/10/12MM VAL FLPTOP RDCR TO CORE DYNAMICS MANUFACTURER NARRATIVE: THE DEVICE WILL NOT BE RETURNED, AND NO PHOTOGRAPHIC EVIDENCE WAS PROVIDED. THEREFORE, THE REPORTED EVENT CANNOT BE VERIFIED. THE MANUFACTURING DOCUMENTS FROM THE DEVICE HISTORY RECORD HAVE BEEN REVIEWED WITH SPECIAL ATTENTION TO THE MANUFACTURING AND INSPECTION OF THE PRODUCT. THE PRODUCT RELEASED FOR DISTRIBUTION WAS FOUND TO HAVE MET ALL SPECIFICATIONS PRIOR TO SHIPMENT. A TWO-YEAR LOT HISTORY REVIEW SHOWS A TOTAL OF 1 DEVICE FOR THIS LOT NUMBER AND FAILURE MODE. (B)(4). PER THE INSTRUCTIONS FOR USE, THE USER IS ADVISED THAT A THOROUGH UNDERSTANDING OF THE PRINCIPLES AND TECHNIQUES INVOLVED IN LAPAROSCOPIC LASER AND ELECTROSURGICAL PROCEDURES IS ESSENTIAL TO AVOID SHOCK AND BURN HAZARDS TO BOTH PATIENT AND MEDICAL PERSONNEL AND DAMAGE TO THE DEVICE OR OTHER MEDICAL INSTRUMENTS. TO PREVENT DAMAGE, THE TROCAR SHOULD NOT BE INTRODUCED INTO THE CANNULA VALVE AT AN ANGLE. WE WILL CONTINUE TO MONITOR FOR TRENDS THROUGH THE COMPLAINT SYSTEM TO ASSURE PATIENT SAFETY.

    Description of Event or Problem · 0

    THE SALES REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER, THAT THE CD612, ENII 5/10/12MM VAL FLPTOP RDCR WAS BEING USED ON 13JUN24 DURING AN ENDOCHOLECYSTECTOMY PROCEDURE WHEN IT WAS REPORTED ¿THE DISPOSABLE PART OF OUR CORE TROCARS FELL INTO THE ABDOMINAL CAVITY DURING THE PROCEDURE. IT WAS SEEN RIGHT AWAY AND RETRIEVED.¿. THE PROCEDURE WAS COMPLETED WITHOUT THE USE OF AN ALTERNATE DEVICE. THE WAS A 5-MINUTE DELAY REPORTED AND ¿SINCE IT WAS SEEN AND RETRIEVED RIGHT AWAY, THERE WAS NO IMPACT ON THE PATIENT.¿. THERE WAS NO REPORT OF INJURY, MEDICAL INTERVENTION, OR EXTENDED HOSPITALIZATION TO THE PATIENT OR USER. THIS REPORT IS BEING RAISED ON THE BASIS OF MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

    Description of Event or Problem · 0

    THE SALES REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER, THAT THE CD612, ENII 5/10/12MM VAL FLPTOP RDCR WAS BEING USED ON 13JUN24 DURING AN ENDOCHOLECYSTECTOMY PROCEDURE WHEN IT WAS REPORTED ¿THE DISPOSABLE PART OF OUR CORE TROCARS FELL INTO THE ABDOMINAL CAVITY DURING THE PROCEDURE. IT WAS SEEN RIGHT AWAY AND RETRIEVED.¿. THE PROCEDURE WAS COMPLETED WITHOUT THE USE OF AN ALTERNATE DEVICE. THERE WAS A 5-MINUTE DELAY REPORTED AND ¿SINCE IT WAS SEEN AND RETRIEVED RIGHT AWAY, THERE WAS NO IMPACT ON THE PATIENT.¿ THERE WAS NO REPORT OF INJURY, MEDICAL INTERVENTION, OR EXTENDED HOSPITALIZATION TO THE PATIENT OR USER. THIS REPORT IS BEING RAISED ON THE BASIS OF MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    757486 CORE DYNAMICS CANNULA AND TROCAR, SUPRAPUBIC, NON-DISPOSABLE FBM CONMED UTICA 202304101 10653405045861

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown