BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AES-50SP PARADIGM EDGE HIP PROBE, 50 DEGREE

    MDR report key: 16952700 · Received May 18, 2023

    Report

    Report Number
    1320894-2023-00089
    Event Type
    Injury
    Date Received
    May 18, 2023
    Date of Event
    May 8, 2023
    Report Date
    July 5, 2023
    Manufacturer
    CONMED UTICA
    Product Code
    GEI
    UDI-DI
    20653405988332
    PMA / PMN Number
    K140578
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL 510K NUMBER K153499 MANUFACTURER NARRATIVE: THE REPORTED DEVICE IS BEING RETURNED TO CONMED FOR EVALUATION. A SUPPLEMENTAL AND FINAL REPORT WILL BE FILED FOLLOWING THE COMPLETION OF THE DEVICE EVALUATION AND COMPLAINT INVESTIGATION. WE WILL CONTINUE TO MONITOR FOR TRENDS THROUGH THE COMPLAINT SYSTEM TO ASSURE PATIENT SAFETY.

    Additional Manufacturer Narrative · 0

    EVALUATION FOUND THE ACTIVE ELECTRODE COMPLETELY DETACHED FROM THE CERAMIC INSULATOR DURING USE IN A HIP PROCEDURE. THE ELECTRODE AND REMAINING PROBE ASSEMBLY HANDLE WERE RETURNED. THE EPOXY ADHESIVE BOND APPEARS TO HAVE DEGRADED TO THE POINT OF FAILURE DUE TO THE HEATING OF THE ELECTRODE TANG LOCATED INSIDE THE CERAMIC COMPONENT WHILE USING THE DEVICE. THE ACTIVE WIRE CONNECTION TO THE ELECTRODE TANG EXHIBITS SOFTENING OF THE SOLDER JOINT AND DETACHMENT OF THE ELECTRODE FROM THE WIRE. IT IS SUSPECTED THAT COMPLETE DETACHMENT OF THE ACTIVE ELECTRODE MAY HAVE OCCURRED WHEN THE DISTAL TIP IS SLIGHTLY BURIED INTERMITTENTLY CLOSING OFF THE ASPIRATION SUCTION LINE CAUSING SUDDEN INCREASED HEATING THAT IS DEGRADING THE BOND LINE AND SOLDER CONNECTION OF THE WIRE AND ELECTRODE. THERE IS NO EVIDENCE OF MISUSE BY THE USER SURGEON. THERE IS NO EVIDENCE OF MANUFACTURING DEFECTS AS THE PROBE ASSEMBLY APPEARS TO BE ASSEMBLED CORRECTLY. 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 2 YEAR LOT HISTORY REVIEW SHOWS A TOTAL OF 2 DEVICES FOR THIS LOT NUMBER AND FAILURE MODE. A TWO-YEAR REVIEW OF COMPLAINT HISTORY REVEALED THERE HAS BEEN A TOTAL OF 64 REPORTS, REGARDING 66 DEVICES, FOR THIS DEVICE FAMILY AND FAILURE MODE. DURING THIS SAME TIME FRAME 209,719 DEVICES HAVE BEEN MANUFACTURED AND SHIPPED WORLDWIDE. SHOULD ALL THE COMPLAINT DEVICES HAVE BEEN FOUND CONFIRMED FOR THIS REPORTED FAILURE, THE RATE OF FAILURE WOULD BE 0.0003. PER THE INSTRUCTIONS FOR USE, THE USER IS ADVISED THE FOLLOWING: MAINTAIN THE PROBE TIP, INCLUDING THE RETURN ELECTRODE, IN THE FIELD OF VIEW AT ALL TIMES. A DETERMINATION FOR FURTHER INVESTIGATION HAS BEEN INITIATED. 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 AES-50SP PARADIGM EDGE HIP PROBE, 50 DEGREE WAS BEING USED ON (B)(6) 2023 DURING A HIP ARTHROSCOPY PROCEDURE AND ¿CIRCULAR METAL FACE OF THE PROBE FELL OFF FROM THE HANDPIECE AND INTO THE JOINT. IT TOOK 2 HOURS TO TRY AND GET IT OUT OF THE JOINT. CAUSED A MAJOR DELAY IN SURGERY BUT NO PATIENT HARM. PATIENT INJURY? NO, BIGGER INCISION THOUGH.¿. THE PROCEDURE WAS COMPLETED. AFTER FURTHER ASSESSMENT IT WAS FOUND THAT THE FRAGMENT WAS RETRIEVED. THERE WAS NO EXTENDED STAY AT THE HOSPITAL FOR THE PATIENT. THIS REPORT IS BEING RAISED DUE TO THE REPORTED INJURY OF A LARGER INCISION WAS NEEDED TO RETRIEVE THE FRAGMENTS FROM THE PATIENT

    Description of Event or Problem · 0

    THE SALES REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER THAT THE AES-50SP PARADIGM EDGE HIP PROBE, 50 DEGREE WAS BEING USED ON (B)(6) 23 DURING A HIP ARTHROSCOPY PROCEDURE AND ¿CIRCULAR METAL FACE OF THE PROBE FELL OFF FROM THE HANDPIECE AND INTO THE JOINT. IT TOOK 2 HOURS TO TRY AND GET IT OUT OF THE JOINT. CAUSED A MAJOR DELAY IN SURGERY BUT NO PATIENT HARM. PATIENT INJURY? NO, BIGGER INCISION THOUGH.¿. THE PROCEDURE WAS COMPLETED. AFTER FURTHER ASSESSMENT IT WAS FOUND THAT THE FRAGMENT WAS RETRIEVED. THERE WAS NO EXTENDED STAY AT THE HOSPITAL FOR THE PATIENT. THIS REPORT IS BEING RAISED DUE TO THE REPORTED INJURY OF A LARGER INCISION WAS NEEDED TO RETRIEVE THE FRAGMENTS FROM THE PATIENT

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1907129 AES-50SP PARADIGM EDGE HIP PROBE, 50 DEGREE ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI CONMED UTICA AES-50SP 202302231 20653405988332

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention| O