BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPATULA ELECTRODE WITH STEALTH ER ,5MM X 32CM

    MDR report key: 11642454 · Received April 9, 2021

    Report

    Report Number
    1320894-2021-00181
    Event Type
    Malfunction
    Date Received
    April 9, 2021
    Date of Event
    March 17, 2021
    Report Date
    May 26, 2021
    Manufacturer
    CONMED CORPORATION
    Product Code
    GEI
    PMA / PMN Number
    K952204
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION OF THE CUSTOMER'S REPORTED ISSUE AND COMPLAINT WAS CONFIRMED BASED ON EVALUATION OF THE RETURNED DEVICE. CONMED RECEIVED ONE 60-5274-032 OPENED IN UNORIGINAL PACKAGING WITH ORIGINAL PACKAGING INCLUDED. THE LOT NUMBER OF THE DEVICE, 202012291, WAS VERIFIED. A VISUAL INSPECTION WAS PERFORMED; AND THE SPATULA WAS RETURNED COMPLETELY OFF THE MOLDED TUBE (P/N 11676-02). THE SPATULA (P/N 7068) SEEMED TO HAVE DETACHED FROM THE WELDED AREA. ALTHOUGH THE REPORTED FAILURE WAS VERIFIED, A ROOT CAUSE CAN NOT BE DETERMINED. THE MANUFACTURING DOCUMENTS FROM THE DEVICE HISTORY RECORD HAVE BEEN REVIEWED AND FOUND NO ABNORMALITIES THAT WOULD CONTRIBUTE TO THIS ISSUE. A 2-YEAR LOT HISTORY REVIEW WAS CONDUCTED AND FOUND NO OTHER SIMILAR EVENTS REPORTED FOR THIS LOT NUMBER. (B)(4). THE INSTRUCTIONS FOR USE (IFU) PROVIDES THE USER WITH INFORMATION REGARDING PROPER CARE AND USE OF THIS DEVICE. THE IFU ADVISES THE USER THAT DURING TROCAR INSERTION, ALWAYS HAVE THE ELECTRODE TIP COVERED TO AVOID POTENTIAL DAMAGE TO TROCAR SEALS AND THE ELECTRODE TIP. EXAMINE THIS DEVICE PRIOR TO USE FOR DAMAGE. DO NOT USE IF DAMAGE IS FOUND. THIS ISSUE WILL CONTINUE TO BE MONITORED THROUGH THE COMPLAINT SYSTEM TO ASSURE PATIENT SAFETY.

    Additional Manufacturer Narrative · 1

    AT TIME OF FILING, ALTHOUGH EXPECTED, THE REPORTED DEVICE HAS NOT BEEN RECEIVED INTO CONMED'S COMPLAINT SYSTEM 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 AN ISSUE WITH THE SPATULA ELECTRODE WITH STEALTH ER, 5MM X 32CM, ITEM # 60-5274-032, LOT 202012291, THAT OCCURRED AT (B)(6) HOSPITAL, (B)(6) ON (B)(6) 2021. IT IS INDICATED THAT DURING A LAPAROSCOPIC CHOLECYSTECTOMY, THE TIP FELL OFF WHILE THE INSTRUMENT WAS BEING USED. IT IS INDICATED THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING ANOTHER SPATULA. THERE WAS NO IMPACT OR INJURY TO THE PATIENT AND THE SURGEON RETRIEVED THE TIP. TO DATE, ALTHOUGH MULTIPLE ATTEMPTS HAVE BEEN MADE TO GATHER ADDITIONAL INFORMATION, NO INFORMATION HAS BEEN PROVIDED. THIS REPORTING IS BEING RAISED AS A DEVICE MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE, AS ALTHOUGH REMOVED, THE TIP DID FALL OFF INTO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    538545 SPATULA ELECTRODE WITH STEALTH ER ,5MM X 32CM ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI CONMED CORPORATION 202012291

    Patients

    Seq Age Sex Outcome Treatment
    1