BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AES-90SN PROBE ASSY,SUCT,SIN

    MDR report key: 13658412 · Received March 3, 2022

    Report

    Report Number
    1320894-2022-00050
    Event Type
    Malfunction
    Date Received
    March 3, 2022
    Date of Event
    December 16, 2021
    Report Date
    March 3, 2022
    Manufacturer
    CONMED UTICA
    Product Code
    GEI
    UDI-DI
    10653405006473
    PMA / PMN Number
    K140578
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    EXAMINATION OF THE RETURNED USED DEVICE FOUND THE ELECTRODE BROKEN OFF FROM THE PROBE TIP. DETACHED ELECTRODE WAS NOT RETURNED PER EVALUATION. EXAMINATION PERFORMED PER EDGE PROBES, STANDARD WORK LINE #1, MP-09-1770 REV AH. 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. THIS IS THE ONLY COMPLAINT FOR THIS LOT NUMBER AND FAILURE MODE WITHIN THE PAST TWO YEARS. A TWO-YEAR REVIEW OF COMPLAINT HISTORY REVEALED THERE HAS BEEN A TOTAL OF 49 COMPLAINTS, REGARDING 52 DEVICES, FOR THIS DEVICE FAMILY AND FAILURE MODE. DURING THIS SAME TIME FRAME (B)(4) 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 TO NOT USE THE PROBE FOR MECHANICAL DISPLACEMENT OF TISSUE, DAMAGE TO THE PROBE MAY OCCUR. THE IFU ALSO ADVISES THE USER TO MAINTAIN THE PROBE TIP, INCLUDING THE RETURN ELECTRODE, IN THE FIELD OF VIEW AT ALL TIMES. ALTERNATE SITE ABLATION MAY OCCUR IF 75% OF THE RETURN ELECTRODE IS MASKED, MAKING THE RETURN ELECTRODE SURFACE AREA SMALLER THAN THAT OF THE ACTIVE ELECTRODE. IF PARTIAL COVERAGE OF THE RETURN ELECTRODE IS REQUIRED FOR THE PROCEDURE, USE A LOWER SETTING AND MAINTAIN VISIBILITY OF THE RETURN ELECTRODE WHILE APPLYING RF. DO NOT ACTIVATE THE PROBE WHILE ANY PORTION OF THE ACTIVE OR RETURN ELECTRODE IS IN CONTACT WITH ANOTHER METAL OBJECT, INCLUDING THE SCOPE; LOCALIZED HEATING OF THE ELECTRODE AND THE ADJACENT METAL OBJECT MAY RESULT IN PRODUCT DAMAGE AND/ OR INJURY. THIS ISSUE WILL CONTINUE TO BE MONITORED 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-90SN, AES-90SN PROBE ASSY,SUCT,SIN, WAS REPORTED AS, ¿DOES NOT WORK.¿ NO IMPACT TO PATIENT WAS REPORTED. UPON ARRIVAL OF THE DEVICE FOR EVALUATION IT WAS FOUND THAT THE FACE PLATE WAS BROKEN AND PIECES WERE MISSING. THE COMPLAINT WAS REASSESSED. ON (B)(6) 2022 NEW ASSESSMENT INFORMATION REVEALED THAT THE DEVICE WAS USED DURING A SHOULDER ARTHROSCOPY ON (B)(6) 2021, WHEN THE DEVICE WAS BROKEN AND PIECES WERE RETRIEVED FROM THE PATIENT. THE PIECES WERE NOT RETURNED WITH THE DEVICE FOR EVALUATION. THE PROCEDURE WAS REPORTED AS HAVING BEEN COMPLETED WITH NO DELAY. THERE WAS NO REPORT OF INJURY, MEDICAL INTERVENTION, OR HOSPITALIZATION FOR THE PATIENT. 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
    1931921 AES-90SN PROBE ASSY,SUCT,SIN ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI CONMED UTICA AES-90SN 202111151 10653405006473

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown