BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LAP PROBE,5 MM, H/SWITCH,36CM

    MDR report key: 18075333 · Received November 6, 2023

    Report

    Report Number
    3007305485-2023-00233
    Event Type
    Malfunction
    Date Received
    November 6, 2023
    Report Date
    January 11, 2024
    Manufacturer
    CONSOLIDATED MEDICAL EQUIPMENT COMPANY
    Product Code
    GEI
    UDI-DI
    30653405003858
    PMA / PMN Number
    K925903
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    RECEIVED ONE 160636 IN OPENED ORIGINAL PACKAGE. LOT NUMBER WAS VERIFIED. PERFORMED A VISUAL INSPECTION, THE COMPLAINT WAS CONFIRMED. THE LAP PROBE TIP OF THE CANNULA WAS BROKEN OFF AND RETURNED WITH THE DEVICE. ROOT CAUSE CANNOT BE DETERMINED, HOWEVER, BASED UPON EVALUATION OF THE DEVICE AND IFU; A POSSIBLE CAUSE OF THIS EVENT COULD BE EXCESSIVE OUTPUT SETTINGS SELECTED. 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. (B)(4). PER THE INSTRUCTIONS FOR USE, THE USER IS ADVISED TO QUESTION UNUSUAL REQUESTS FOR INCREASED POWER OUTPUT SETTINGS. SUCH REQUESTS SHOULD INITIATE A CHECK OF INTEGRITY/CONDITION OF ALL CORDS, CONNECTIONS, AND ELECTRODES INCLUDING THE DISPERSIVE ELECTRODE (GROUND PAD) BEFORE A POWER INCREASE IS MADE. WE WILL CONTINUE TO MONITOR FOR TRENDS THROUGH THE COMPLAINT SYSTEM TO ASSURE PATIENT SAFETY.

    Additional Manufacturer Narrative · 0

    THE DEVICE IS NOT EXPECTED TO BE RETURNED FOR EVALUATION AND REVIEW. HOWEVER, THE COMPLAINT INVESTIGATION IS NOT COMPLETE AT THIS TIME. A SUPPLEMENTAL AND FINAL REPORT WILL BE FILED FOLLOWING THE COMPLETION OF THE COMPLAINT INVESTIGATION. WE WILL CONTINUE TO MONITOR FOR TRENDS THROUGH THE COMPLAINT SYSTEM TO ASSURE PATIENT SAFETY.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THAT THE 160636, LAP PROBE,5 MM, H/SWITCH,36CM DEVICE WAS BEING USED DURING AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE WHEN IT WAS REPORTED ¿WE HAD AN INCIDENT WITH CONMED ARGON LAPAROSCOPIC PROBE WHERE IT GOT MELTED AND BROKEN WHILE USING.¿. FURTHER ASSESSMENT QUESTIONING FOUND THAT THE DEVICE DID FRAGMENT AND WAS REMOVED FROM THE SURGICAL SITE WITH THE USE OF LAPAROSCOPIC BOWEL GRASPER. THERE WAS NO REPORT OF INJURY, MEDICAL INTERVENTION, OR EXTENDED HOSPITALIZATION FOR THE PATIENT OR USER. THIS REPORT IS BEING RAISED ON THE REPORTED MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THAT THE 160636, LAP PROBE,5 MM, H/SWITCH,36CM DEVICE WAS BEING USED DURING AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE WHEN IT WAS REPORTED ¿WE HAD AN INCIDENT WITH CONMED ARGON LAPAROSCOPIC PROBE WHERE IT GOT MELTED AND BROKEN WHILE USING.¿ FURTHER ASSESSMENT QUESTIONING FOUND THAT THE DEVICE DID FRAGMENT AND WAS REMOVED FROM THE SURGICAL SITE WITH THE USE OF LAPAROSCOPIC BOWEL GRASPER. THERE WAS NO REPORT OF INJURY, MEDICAL INTERVENTION, OR EXTENDED HOSPITALIZATION FOR THE PATIENT OR USER. THIS REPORT IS BEING RAISED ON THE REPORTED MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1929141 LAP PROBE,5 MM, H/SWITCH,36CM ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI CONSOLIDATED MEDICAL EQUIPMENT COMPANY 202304124 30653405003858

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown