BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AES-50SP PARADIGM EDGE HIP PROBE, 50 DEGREE

    MDR report key: 17001589 · Received May 25, 2023

    Report

    Report Number
    1320894-2023-00092
    Event Type
    Malfunction
    Date Received
    May 25, 2023
    Date of Event
    May 8, 2023
    Report Date
    May 25, 2023
    Manufacturer
    CONMED UTICA
    Product Code
    GEI
    UDI-DI
    20653405988332
    PMA / PMN Number
    K140578
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    G3 ADDITIONAL 510K: K153499 MANUFACTURER NARRATIVE: THE DEVICE WILL NOT BE RETURNED, AND NO PHOTOGRAPHIC EVIDENCE WAS PROVIDED. THEREFORE, THE REPORTED EVENT CANNOT BE VERIFIED. 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 SHOWS A TOTAL OF 3 DEVICES FOR THIS LOT NUMBER AND FAILURE MODE. A TWO-YEAR REVIEW OF COMPLAINT HISTORY REVEALED THERE HAS BEEN A TOTAL OF 50 REPORTS, REGARDING 50 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 THE FOLLOWING: 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. 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. WE WILL CONTINUE TO MONITOR FOR TRENDS THROUGH THE COMPLAINT SYSTEM TO ASSURE PATIENT SAFETY.

    Description of Event or Problem · 0

    THIS COMPLAINT WAS CREATED DUE TO THE RECEIPT OF A MEDWATCH REPORT (MW5117479) RECEIVED ON (B)(6) 2023. A SEARCH OF THE COMPLAINT SYSTEM HAS NOT FOUND A COMPLAINT REPORTED FOR THIS DEVICE/LOT NUMBER DURING THIS TIMEFRAME. THE REPORT WAS FOUND TO BE WRITTEN AGAINST THE AES-50SP PARADIGM EDGE HIP PROBE. THE REPORT STATES THAT ON (B)(6) 2023 ¿WHILE USING PARADIGM HIP PROBE, A PIECE BECAME DISLODGED FROM PROBE AND HAD TO BE REMOVED. RETRIEVAL OF THE FOREIGN BODY CAUSED A 1 HOUR DELAY.¿. THERE WAS INJURY OR IMPACT TO THE PATIENT OR USER. FURTHER ASSESSMENT COULD NOT BE SENT AS THE REPORTER DID NOT IDENTIFY HIMSELF/HERSELF, OR THE FACILITY WHERE THE EVENT OCCURRED. THIS REPORT IS BEING RAISED DUE TO THE REPORTED MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1516178 AES-50SP PARADIGM EDGE HIP PROBE, 50 DEGREE ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI CONMED UTICA AES-50SP 202302231 20653405988332

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown