BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AES 50 DEG PROBE WITH SUCTION

    MDR report key: 10968488 · Received December 8, 2020

    Report

    Report Number
    1320894-2020-00538
    Event Type
    Malfunction
    Date Received
    December 8, 2020
    Date of Event
    November 16, 2020
    Report Date
    January 22, 2021
    Manufacturer
    CONMED CORPORATION
    Product Code
    GEI
    PMA / PMN Number
    K153499
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    CUSTOMER EVENT "A PORTION OF THE COATING (BLACK PLASTIC) 1 CM TO THE ELECTRODE HAS COME OFF DURING USE" WAS CONFIRMED BASED ON PHOTOGRAPHIC EVIDENCE AND DEVICE EVALUATION. EXAMINATION OF THE RETURNED USED DEVICE ITEM AES-50S FOUND DEVICE ELECTRODE COATING DAMAGE AT THE SHAFT, ALSO THE CERAMIC TIP HAS BEEN DAMAGED AT THE TIP. SUSPECT DEVICE WAS IN CONTACT WITH ANOTHER DEVICE THAT CONTRIBUTED TO THIS FAILURE. EXAMINATION WAS 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. A TWO-YEAR LOT HISTORY REVIEW WAS CONDUCTED AND FOUND NO OTHER SIMILAR EVENTS REPORTED FOR THIS LOT NUMBER. A TWO-YEAR REVIEW OF COMPLAINT HISTORY REVEALED THERE HAS BEEN A TOTAL OF 8 COMPLAINTS, REGARDING 8 DEVICES, FOR THIS DEVICE FAMILY AND FAILURE MODE. DURING THIS SAME TIME FRAME 160,838 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 0.00005. PER THE INSTRUCTIONS FOR USE, THE USER IS ADVISED THE FOLLOWING: THE USER IS ADVISED 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. DO NOT ACTIVATE THE ELECTRODE WHILE ANY PORTION OF THE ELECTRODE TIP 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 CUSTOMER REPORTED THAT THE DEVICE, AES-50S, WAS BEING USED DURING A KNEE ARTHROSCOPY PROCEDURE ON (B)(6) 2020 WHEN "A PORTION OF THE COATING (BLACK PLASTIC) 1 CM TO THE ELECTRODE HAS COME OFF DURING USE." THE PROCEDURE WAS COMPLETED WITH AN ALTERNATE SAME-LIKE DEVICE. THERE WAS A FOUR MINUTE DELAY. THERE WAS NO REPORT OF IMPACT/INJURY TO 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
    1434672 AES 50 DEG PROBE WITH SUCTION ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI CONMED CORPORATION 202007201

    Patients

    Seq Age Sex Outcome Treatment
    1