BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARTHROSCOPIC ENERGY 50 DEGREE PROBE WITH SUCTION 18 CM

    MDR report key: 14433912 · Received May 19, 2022

    Report

    Report Number
    1320894-2022-00096
    Event Type
    Malfunction
    Date Received
    May 19, 2022
    Date of Event
    May 6, 2022
    Report Date
    May 31, 2022
    Manufacturer
    CONMED UTICA
    Product Code
    GEI
    UDI-DI
    10653405004974
    PMA / PMN Number
    K153499
    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-50SL CONFIRM THE REPORTED PROBLEM, AND FOUND DEVICE ELECTRODE BROKEN OFF FROM THE PROBE TIP. DETACHED ELECTRODE WAS NOT RETURNED PER EVALUATION. SEE ATTACHED PHOTO. 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. A TWO-YEAR LOT HISTORY REVIEW WAS CONDUCTED AND FOUND NO SIMILAR EVENTS REPORTED FOR THIS LOT NUMBER. A TWO-YEAR REVIEW OF COMPLAINT HISTORY REVEALED THERE HAS BEEN A TOTAL OF 60 COMPLAINTS, REGARDING 63 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 (B)(4). PER THE INSTRUCTIONS FOR USE, THE USER IS ADVISED IF ANY VISUAL DAMAGE OR DEFECTS ARE NOTICED DURING USE, STOP USING THE DEVICE IMMEDIATELY AND REPLACE THE DEVICE. 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. 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. 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-50SL, ARTHROSCOPIC ENERGY 50 DEGREE PROBE WITH SUCTION 18 CM, WAS USED DURING A HIP SCOPE PROCEDURE ON (B)(6) 2022 WHEN IT WAS REPORTED THAT THE HEAD OF THE ABLATOR CAME OUT BUT WAS ABLE TO BE RETRIEVED. FURTHER ASSESSMENT QUESTIONING FOUND THE DEVICE WAS IN THE STERILE FIELD WHEN 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-50SL, ARTHROSCOPIC ENERGY 50 DEGREE PROBE WITH SUCTION 18 CM, WAS USED DURING A HIP SCOPE PROCEDURE ON (B)(6) 2022 WHEN IT WAS REPORTED THAT THE HEAD OF THE ABLATOR CAME OUT BUT WAS ABLE TO BE RETRIEVED. FURTHER ASSESSMENT QUESTIONING FOUND THE DEVICE WAS IN THE STERILE FIELD WHEN 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
    393325 ARTHROSCOPIC ENERGY 50 DEGREE PROBE WITH SUCTION 18 CM ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI CONMED UTICA AES-50SL 202110181 10653405004974

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown