BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AES-90 DEGREE PROBE, SUCT, SN

    MDR report key: 10449361 · Received August 25, 2020

    Report

    Report Number
    1320894-2020-00369
    Event Type
    Malfunction
    Date Received
    August 25, 2020
    Date of Event
    August 5, 2020
    Report Date
    September 21, 2020
    Manufacturer
    CONMED CORPORATION
    Product Code
    GEI
    PMA / PMN Number
    K140578
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    EXAMINATION OF THE RETURNED USED DEVICE, ITEM AES-90SN, QTY OF TWO CONFIRM THE REPORTED PROBLEM AND FOUND ELECTRODE DETACHED FROM THE TIP OF THE PROBE, ONLY AT ONE OF THE RETURNED DEVICES. 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 8 COMPLAINTS, REGARDING 9 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: WARNINGS: IT IS THE SURGEON'S RESPONSIBILITY TO BE FAMILIAR WITH THE APPROPRIATE SURGICAL TECHNIQUES PRIOR TO USE OF THE EQUIPMENT AND ITS ASSOCIATED ACCESSORIES. DO NOT USE EQUIPMENT IF, UPON RECEIPT, PACKAGE IS OPENED, DAMAGED OR SHOWS SIGNS OF TAMPERING. IF ANY VISUAL DAMAGE OR DEFECTS ARE NOTICED DURING USE, STOP USING THE DEVICE IMMEDIATELY AND REPLACE THE DEICE. USE CARE WHEN INSERTING INTO AND WITHDRAWING THE PROBE FROM A CANNULA OR TISSUE PORTAL TO AVOID THE POSSIBILITY OF DAMAGE TO THE DEVISE AND/OR INJURY TO THE PATIENT. MAINTAIN THE PROBE TIP, INCLUDING THE RETURN ELECTRODE, IN THE FIELD OF VIEW AT ALL TIMES. INJURIES MAY RESULT FROM INADVERTENT ACTIVATION OR MOVEMENT OF AN ACTIVATED PROBE OUTSIDE THE FIELD OF VIEW. PRECAUTIONS: DO NOT BEND PROBE SHAFT OR ALTER THE DEVICE IN ANYWAY, DAMAGE TO THE DEVICE MAY OCCUR 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-90SN, WAS BEING USED DURING AN UNKNOWN PROCEDURE ON (B)(6) 2020 WHEN THE "TIP OF THE PROBE BROKE AND WAS LOST (ALMOST IN THE PATIENT)". SINCE THE COMPONENT WAS NOT LOST IN THE PATIENT AND THERE IS NO REPORT OF REMAINING IN THE PATIENT, THERE WAS NOTHING TO RETRIEVE FROM THE PATIENT. THERE WAS NO REPORT OF INJURY TO THE PATIENT. THE REPORTER STATED THAT THE PROCEDURE WAS NOT COMPLETED; HOWEVER, FURTHER ASSESSMENT INFORMATION WAS REQUESTED TO DETERMINE THE REASON FOR THIS DECISION AND THE CUSTOMER DECLINED TO RESPOND TO OUR QUESTIONS. 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
    915951 AES-90 DEGREE PROBE, SUCT, SN ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI CONMED CORPORATION 202003231

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR