BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONMED

    MDR report key: 20891656 · Received December 10, 2024

    Report

    Report Number
    1320894-2024-00424
    Event Type
    Malfunction
    Date Received
    December 10, 2024
    Date of Event
    November 19, 2024
    Report Date
    January 17, 2025
    Manufacturer
    CONMED UTICA
    Product Code
    HFG
    UDI-DI
    30653405009768
    PMA / PMN Number
    K904240
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    EXAMINATION OF RETURNED USED DEVICE 60-5163-001 FOUND THAT THERE WAS NO INSULATION ON THE L HOOK. THE ROOT CAUSE CANNOT BE DETERMINED, HOWEVER, BASED UPON EVALUATION AND IFU, THE LIKELY CAUSE OF THIS EVENT WAS EXCESSIVE FORCE THAT CAUSED THE DEVICE TO BECOME DAMAGED. 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 1 REPORT, REGARDING 1 DEVICE, FOR THIS DEVICE FAMILY AND FAILURE MODE. DURING THIS SAME TIME FRAME 270,540 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 0.000004. PER THE INSTRUCTIONS FOR USE, THE USER IS ADVISED THE FOLLOWING: FOLLOW ALL MANUFACTURER¿S GUIDELINES FOR ELECTROSURGICAL SAFETY. ALWAYS USE THE LOWEST POSSIBLE POWER SETTING TO ACHIEVE THE DESIRED ELECTROSURGICAL EFFECT DO NOT ACTIVATE THE ELECTROSURGICAL UNIT UNTIL THE TIP OF THE INSTRUMENT IS TOUCHING THE TARGET TISSUE, OR IN VERY CLOSE PROXIMITY TO IT IN THE INSTANCE OF FULGURATION (SPRAY COAGULATION). DO NOT ACTIVATE THE ELECTROSURGICAL UNIT IF YOU CANNOT CLEARLY SEE THE POSITION OF THE INSTRUMENT TIP WITH RESPECT TO ALL SURROUNDING TISSUES AND STRUCTURES. DO NOT ACTIVATE THE ELECTROSURGICAL INSTRUMENT IF THE TIP OF THE INSTRUMENT IS WITHIN THE TROCAR CANNULA. WE WILL CONTINUE TO MONITOR PER REGULATORY REQUIREMENTS TO HELP ENSURE PATIENT SAFETY.

    Additional Manufacturer Narrative · 0

    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. WE WILL CONTINUE TO MONITOR PER REGULATORY REQUIREMENTS TO HELP ENSURE PATIENT SAFETY.

    Description of Event or Problem · 0

    THE SALES REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER THAT THE 60-5163-001, LAPAROSCOPIC ELECTRODE WITH A 3/32" PIN CONNECTOR,L-HOOK WAS BEING USED ON (B)(6) 2024 DURING A LAPAROSCOPIC PROCEDURE AND ¿THE COATING/INSULATION ON THE LHOOK HAD COME OFF.¿. PER FURTHER ASSESSMENT IT WAS FOUND THAT "NO FRAGMENT FELL INTO THE SURGICAL SITE.". THERE WAS NO IMPACT OR INJURY TO THE PATIENT. THERE WAS NO DELAY TO THE PROCEDURE. THIS REPORT IS BEING RAISED DUE TO THE REPORTED MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

    Description of Event or Problem · 0

    THE SALES REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER THAT THE 60-5163-001, LAPAROSCOPIC ELECTRODE WITH A 3/32" PIN CONNECTOR, L-HOOK WAS BEING USED ON (B)(6) 2024 DURING A LAPAROSCOPIC PROCEDURE AND ¿THE COATING/INSULATION ON THE LHOOK HAD COME OFF.¿ PER FURTHER ASSESSMENT IT WAS FOUND THAT "NO FRAGMENT FELL INTO THE SURGICAL SITE." THERE WAS NO IMPACT OR INJURY TO THE PATIENT. THERE WAS NO DELAY TO THE PROCEDURE. 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
    2502764 CONMED COAGULATOR, LAPAROSCOPIC, UNIPOLAR (AND ACCESSORIES) HFG CONMED UTICA 202407221 30653405009768

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown