BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AES-90SN PROBE ASSY,SUCT,SIN

    MDR report key: 10642982 · Received October 7, 2020

    Report

    Report Number
    1320894-2020-00433
    Event Type
    Malfunction
    Date Received
    October 7, 2020
    Date of Event
    September 23, 2020
    Report Date
    November 20, 2020
    Manufacturer
    CONMED CORPORATION
    Product Code
    GEI
    PMA / PMN Number
    K153499
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    EXAMINATIONS OF THE RETURNED USED DEVICE FOUND DEVICE ELECTRODE BROKEN. EXAMINATION WAS PERFORMED PER EDGE PROBES, STANDARD WORK LINE #1, MP-09-1770, REV-AH. IN ADDITION, THE CUSTOMER PROVIDED EVIDENCE OF THE PATIENT X-RAY SHOWING THE TIP BROKE OFF THE DEVICE. THE MANUFACTURING DOCUMENTS FROM THE DEVICE HISTORY RECORD HAVE NOT BEEN REVIEWED BECAUSE THE LOT NUMBER OF THE DEVICE IS NOT KNOW. THE LOT HISTORY REVIEW COULD NOT BE CONDUCTED BECAUSE THE LOT NUMBER OF THE DEVICE IS NOT KNOWN. A TWO-YEAR REVIEW OF COMPLAINT HISTORY REVEALED THERE HAS BEEN A TOTAL OF 18 COMPLAINTS, REGARDING 19 DEVICES, FOR THIS DEVICE FAMILY AND FAILURE MODE. DURING THIS SAME TIME FRAME (B)(4) 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 (B)(4). PER THE INSTRUCTIONS FOR USE, THE USER IS ADVISED THE FOLLOWING: WARNINGS: DO NOT INSERT, WITHDRAW OR TOUCH THE ACTIVE TIP OF THE PROBE WHEN POWER IS BEING APPLIED. THIS MAY RESULT IN AN UNINTENDED SURGICAL EFFECT, INJURY, OR DEVICE DAMAGE. MAINTAIN THE ACTIVE 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. 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.

    Additional Manufacturer Narrative · 1

    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. THIS ISSUE WILL CONTINUE TO BE MONITORED THROUGH THE COMPLAINT SYSTEM TO ASSURE PATIENT SAFETY.

    Description of Event or Problem · 1

    THE SALES REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER THAT THE AES-90SN DEVICE WAS BEING USED DURING AN TIBIAL TUBERCLE TRANSFER WITH ARTHROSCOPIC LATERAL RETINACULAR RELEASE ON (B)(6) 2020 WHEN ¾ OF THE TIP OF THE DEVICE BROKE OFF IN THE PATIENT. AN X-RAY WAS TAKEN TO FIND THE DEVICE COMPONENT AND IT WAS RETRIEVED FROM THE PATIENT USING GRASPERS. THE PROCEDURE WAS COMPLETED AFTER A 10-15-MINUTE DELAY. THERE WAS NO REPORT OF INJURY, MEDICAL INTERVENTION OR HOSPITALIZATION DUE TO THE EVENT. 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
    1111182 AES-90SN PROBE ASSY,SUCT,SIN ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI CONMED CORPORATION UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR