BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AES-90SN PROBE ASSY,SUCT,SIN

    MDR report key: 14433837 · Received May 19, 2022

    Report

    Report Number
    1320894-2022-00095
    Event Type
    Malfunction
    Date Received
    May 19, 2022
    Date of Event
    May 6, 2022
    Report Date
    June 1, 2022
    Manufacturer
    CONMED UTICA
    Product Code
    GEI
    UDI-DI
    10653405006473
    PMA / PMN Number
    K140578
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED DEVICE HAS BEEN RETURNED TO CONMED; HOWEVER, THE INVESTIGATION OF THE DEVICE HAS NOT BEEN COMPLETED. 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.

    Additional Manufacturer Narrative · 0

    EXAMINATIONS OF THE RETURNED USED DEVICE, ITEM AES-90SN CONFIRM THE REPORTED PROBLEM, AND FOUND DEVICE ELECTRODE BROKEN OFF FROM THE PROBE TIP. DETACHED ELECTRODE WAS NOT RETURNED PER EVALUATION.RETURNED CONDITION OF DEVICE SHOWS DEVICE WAS PREVIOUSLY USED. 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. 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 6 COMPLAINTS, REGARDING 6 DEVICES, FOR THIS DEVICE FAMILY AND FAILURE MODE. DURING THIS SAME TIME FRAME 181,900 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 (B)(4). PER THE INSTRUCTIONS FOR USE, THE USER IS ADVISED TO 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. 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 USED DURING A SHOULDER SCOPE PROCEDURE ON (B)(6) 2022 WHEN IT WAS REPORTED THAT A ¿PIECE OF THE HEAD CAME OFF, WAS ABLE TO GET IT OUT¿. FURTHER ASSESSMENT QUESTIONING FOUND, THE DEVICE WAS IN THE STERILE FIELD WHEN IN IT FRAGMENTED AND FELL INTO THE SURGICAL SITE. THE FRAGMENT WAS RETRIEVED USING ANOTHER SURGICAL INSTRUMENT ((B)(4)). THE PROBE WAS NOT USED TO FINISH THE PROCEDURE. DUE TO THE DEVICE BREAKING IT "SLOWED OR TIME BY A FEW MINUTES". IT WAS REPORTED THAT THERE WAS NO INJURY TO THE PATIENT AND NO MEDICAL/SURGICAL INTERVENTION OR HOSPITALIZATION WAS REQUIRED FOR THE PATIENT. THE CASE WAS COMPLETED WITH "NO ADDITIONAL ISSUES". THIS REPORT IS BEING RAISED ON THE BASIS OF MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

    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 USED DURING A SHOULDER SCOPE PROCEDURE ON (B)(6) 2022 WHEN IT WAS REPORTED THAT A ¿PIECE OF THE HEAD CAME OFF, WAS ABLE TO GET IT OUT¿. FURTHER ASSESSMENT QUESTIONING FOUND, THE DEVICE WAS IN THE STERILE FIELD WHEN IN IT FRAGMENTED AND FELL INTO THE SURGICAL SITE. THE FRAGMENT WAS RETRIEVED USING ANOTHER SURGICAL INSTRUMENT (GRASPER). THE PROBE WAS NOT USED TO FINISH THE PROCEDURE. DUE TO THE DEVICE BREAKING IT "SLOWED OR TIME BY A FEW MINUTES". IT WAS REPORTED THAT THERE WAS NO INJURY TO THE PATIENT AND NO MEDICAL/SURGICAL INTERVENTION OR HOSPITALIZATION WAS REQUIRED FOR THE PATIENT. THE CASE WAS COMPLETED WITH "NO ADDITIONAL ISSUES". 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
    1976941 AES-90SN PROBE ASSY,SUCT,SIN ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI CONMED UTICA AES-90SN 202201311 10653405006473

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown