BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARTHROSCOPIC ENERGY 50 DEGREE PROBE WITH SUCTION 18 CM

    MDR report key: 18054368 · Received November 2, 2023

    Report

    Report Number
    1320894-2023-00239
    Event Type
    Malfunction
    Date Received
    November 2, 2023
    Date of Event
    October 5, 2023
    Report Date
    December 27, 2023
    Manufacturer
    CONMED UTICA
    Product Code
    GEI
    UDI-DI
    20653405004971
    PMA / PMN Number
    K153499
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GR
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    EXAMINATION OF THE RETURNED USED DEVICE, ITEM AES-50SL CONFIRM THE REPORTED PROBLEM, AND FOUND ELECTRODE TIP DETACHED FROM THE DEVICE SHAFT. THE DETACHED ELECTRODE TIP WAS NOT RETURNED. NO DAMAGE TO THE SHAFT WAS FOUND. EXAMINATION WAS PERFORMED PER EDGE PROBES, STANDARD WORK LINE #1, MP-09-1770. ROOT CAUSE CANNOT BE DETERMINED, HOWEVER, BASED UPON EVALUATION OF THE DEVICE; A POSSIBLE CAUSE OF THIS EVENT COULD BE UTILIZING THE PROBE TO PRY AND MANIPULATE TISSUE EXPOSING THE DISTAL TIP TO UNDUE FORCE AND STRESS, OR IF THE USER UTILIZES THE PROBE WELL OVER ITS INTENDED LIFE. 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 TWO (2) DEVICES FOR THIS LOT NUMBER AND FAILURE MODE. A TWO-YEAR REVIEW OF COMPLAINT HISTORY REVEALED THERE HAS BEEN A TOTAL OF 16 COMPLAINTS, REGARDING 16 DEVICES, FOR THIS DEVICE FAMILY AND FAILURE MODE. DURING THIS SAME TIME FRAME 209,047 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 0.00007. 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. INJURIES TO THE PATIENT MAY RESULT FROM INADVERTENT ACTIVATION OR MOVEMENT OF AN ACTIVATED PROBE OUTSIDE THE FIELD OF VIEW. CARE SHOULD BE TAKEN IN PROCEDURES THAT MAY COVER THE PROBE RETURN ELECTRODE. DO NOT USE THE PROBE FOR MECHANICAL DISPLACEMENT OF TISSUE, DAMAGE TO THE PROBE MAY OCCUR. WE WILL CONTINUE TO MONITOR FOR TRENDS THROUGH THE COMPLAINT SYSTEM TO ASSURE PATIENT SAFETY.

    Additional Manufacturer Narrative · 0

    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. H3 OTHER TEXT : DEVICE NOT YET RECEIVED.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THAT THE DEVICE, AES-50SL, ARTHROSCOPIC ENERGY 50 DEGREE PROBE WITH SUCTION 18 CM, WAS BEING USED DURING AN ARTHROSCOPY PROCEDURE ON (B)(6) 2023 WHEN IT WAS REPORTED, ¿THE TIP BROKE DURING SURGERY.¿. THERE WAS NO REPORT OF INJURY, MEDICAL INTERVENTION, OR HOSPITALIZATION FOR THE PATIENT. THE FRAGMENTATION WAS RETRIEVED PER THE PHOTOGRAPH THAT WAS RECEIVED FROM THE REPORTER. THE PROCEDURE WAS COMPLETED USING AN ALTERNATE, UNKNOWN DEVICE AND THERE WAS NO REPORT OF DELAY IN THE PROCEDURE. THIS REPORT IS BEING RAISED DUE TO THE REPORTED MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THAT THE DEVICE, AES-50SL, ARTHROSCOPIC ENERGY 50 DEGREE PROBE WITH SUCTION 18 CM, WAS BEING USED DURING AN ARTHROSCOPY PROCEDURE ON (B)(6) 2023 WHEN IT WAS REPORTED, ¿THE TIP BROKE DURING SURGERY.¿ THERE WAS NO REPORT OF INJURY, MEDICAL INTERVENTION, OR HOSPITALIZATION FOR THE PATIENT. THE FRAGMENTATION WAS RETRIEVED PER THE PHOTOGRAPH THAT WAS RECEIVED FROM THE REPORTER. THE PROCEDURE WAS COMPLETED USING AN ALTERNATE, UNKNOWN DEVICE AND THERE WAS NO REPORT OF DELAY IN THE PROCEDURE. THIS REPORT IS BEING RAISED DUE TO THE REPORTED MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    131009 ARTHROSCOPIC ENERGY 50 DEGREE PROBE WITH SUCTION 18 CM ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI CONMED UTICA 202207181 20653405004971

    Patients

    Seq Age Sex Outcome Treatment
    1 Male