BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SURGYCUT

    MDR report key: 20055912 · Received August 23, 2024

    Report

    Report Number
    3004777218-2024-00001
    Event Type
    Malfunction
    Date Received
    August 23, 2024
    Date of Event
    June 17, 2024
    Report Date
    August 21, 2024
    Manufacturer
    U.S. SURGITECH INC
    Product Code
    GEI
    UDI-DI
    00810014631103
    PMA / PMN Number
    K911316
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE ACTUAL DEVICE USED DURING THE SURGICAL PROCEDURE WAS NOT RETURNED TO THE COMPANY FOR EVALUATION AS IT WAS DISCARDED, AND A NEW SAME DEVICE WAS USED TO COMPLETE THE PROCEDURE. THEREFORE, PROPER INVESTIGATION ON THE STATED DEVICE USED IN THIS SURGICAL PROCEDURE COULD NOT BE PERFORMED DUE TO UNAVAILABILITY OF THE DEVICE. THE DEVICE MODEL WITH DIFFERENT LOT NO. AT THE CONTRACT MANUFACTURING FACILITY WAS TESTED. A PERFORMANCE TEST WAS PERFORMED ON A PIECE OF MEAT BY ACTIVATING THE DEVICE BY HF GENERATOR. NO PEELING OFF THE COATING MATERIAL WAS DETECTED WHEN TESTING WAS PERFORMED ON ANOTHER LOT OF THE SAME DEVICE MODEL. THEREFORE, THERE COULD BE A POSSIBILITY OF EXCESS HEAT GENERATION DURING THE ELECTROSURGERY THAT MIGHT HAVE CAUSED THE DELAMINATION OF THE TIP COATING MATERIAL. THE DEVICE INSTRUCTIONS FOR USE CLEARLY STATES, "USING COATED ELECTRODES AT HIGH POWER SETTINGS MAY CAUSE DAMAGE TO THE COATING. IF THE COATING IS DAMAGED, DISCARD THE ELECTRODE". ON 07/22/2024 AND 07/23/2024, TWO MORE SIMILAR MALFUNCTIONS WERE REPORTED TO U.S. SURGITECH BY FDA (REPORT MW5156641 & REPORT NO. MW5156752) FOR SAME LOT NO. 20231020 OF J-HOOK ELECTRODES (790-104-535). THEREFORE, BASED ON THOSE EVENTS HAPPENING IN THE SAME USER FACILITY, IT WAS DECIDED TO WITHDRAW THE PRODUCT WITH THIS PARTICULAR LOT NO. FROM THE USER FACILITY. AS THESE DEVICES WITH THE SAME LOT NO. WERE SOLD TO ONLY ONE USER FACILITY, ALL DEVICES OF J-HOOK (790-104-535) LOT NO. 20231020 WERE REQUESTED TO THE FACILITY TO RETURN, AND A HOLD IS PUT ON THE SALES OF THIS PRODUCT UNTIL CORRECTIVE ACTIONS ARE TAKEN. THE TWO SAMPLES RETURNED FOR OTHER CASES WERE COVERED WITH BLOOD AND DEBRIS, MAKING IT DIFFICULT TO SEE BELOW, HOWEVER, IT SEEMS MINUTE PORTION OF COATING PEELED OFF. THIS COULD BE DUE TO HIGH VOLTAGE USE OR THERE COULD BE A POSSIBILITY OF COATING NOT BEING PERFORMED APPROPRIATELY. TO MITIGATE SUCH RISKS IN FUTURE, OUR CONTRACT MANUFACTURER IS REPLACING THE DIP COATING METHOD OF TIPS WITH SPRAY COATING AS A CORRECTIVE ACTION SO THAT THE COATING LAYER IS MORE UNIFORMLY DEPOSITED ON ALL THE TIP SURFACES AND BY CHANCE IF USED AT HIGHER VOLTAGES BY THE USER, PEEL OFF CAN BE PREVENTED. AS OF 08/15/2024, ALL 55 UNITS OF UNUSED PRODUCTS OUT OF (B)(6) UNITS SOLD TO THE USER FACILITY ARE RECEIVED BACKED BY THE COMPANY, WHEREAS THE REMAINING WERE USED BY THE USER FACILITY AND THERE IS NO PRODUCT REMAINING IN THE USER FACILITY THAT CAN CAUSE ANY FURTHER MALFUNCTIONING ISSUE. PLEASE NOTE: THE 30 DAYS REPORT IS DELAYED DUE TO THE DELAY IN PRODUCTION WEB TRADER ACCOUNT ISSUANCE, AS COMPANY IS SUBMITTING EMDR FOR THE FIRST TIME. THE USER FACILITY HAS ALREADY REPORTED THIS CASE TO THE FDA UNDER REPORT NO. MW5156449.

    Description of Event or Problem · 0

    J-HOOK COATING STARTED COMING OFF WHILE IN USE. PERFORMED A LAPAROSCOPIC CHOLECYSTECTOMY. DURING THE PROCEDURE THE J-HOOK COATING BEGAN TO COME OFF WHILE THE SURGEON WAS USING. IT WAS DISCARDED AND A NEW J-HOOK WAS UTILIZED TO CONTINUE THE CASE. THERE WAS NO HARM TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1527884 SURGYCUT J-HOOK ELECTRODE GEI U.S. SURGITECH INC 790-104-535 20231020 00810014631103

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Male Other