BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENSEAL X1 CURVED 37CM SHAFT

    MDR report key: 15971490 · Received December 13, 2022

    Report

    Report Number
    3005075853-2022-08580
    Event Type
    Malfunction
    Date Received
    December 13, 2022
    Date of Event
    January 1, 2022
    Report Date
    December 13, 2022
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GEI
    UDI-DI
    20705036015465
    PMA / PMN Number
    K172580
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). DATE OF EVENT: ONLY EVENT YEAR KNOWN: 2022. BATCH # UNK. NO LOT OR BATCH NUMBER WAS PROVIDED THEREFORE A DEVICE HISTORY COULD NOT BE DONE. ADDITIONAL INFORMATION WAS REQUESTED, AND THE FOLLOWING WAS OBTAINED: DID THE ELECTRODE CERAMIC SEPARATE OR BREAK OFF? NO. DID THE I BLADE GET DAMAGED OR BREAK OFF? NO. IS THE JAW DAMAGED BUT NOT BROKEN OFF? YES, THE JAW WAS BROKEN OFF DURING THE PROCEDURE. IS THE TOP JAW LOOSE BUT NOT DETACHED? NO. IS THE TOP JAW PTC MATERIAL DAMAGED? NO. IS THE BLACK PTC IN THE UPPER JAW DETACHED? NO. IS THE TOP JAW BROKEN OFF THE OF THE DEVICE? NO. THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY ETHICON, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, ETHICON, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 0

    (B)(4). DATE SENT: 1/3/2023. D4 BATCH #: X94X8J. INVESTIGATION SUMMARY: THE PRODUCT WAS RETURNED FOR EVALUATION. VISUAL INSPECTION AND FUNCTIONAL TESTING WERE CONDUCTED ON THE RETURNED DEVICE. VISUAL ANALYSIS OF THE RETURNED SAMPLE DETERMINED THAT THE DEVICE WAS RETURNED WITH THE DISTAL GUIDE WELD BROKEN. ADDITIONALLY, THE TOP JAW IS NOT MISSING AS REPORTED. UPON VISUAL INSPECTION, OF THE DEVICE, IT WAS OBSERVED THAT THE GROUND AND ACTIVE ROD WIRES WERE BROKEN AT THE DISTAL GUIDE AREA. THE DEVICE WAS TESTED ON THE GENERATOR, THIS RESULTED IN THE ¿CLOSE JAWS ON TISSUE AND REACTIVATE¿ ALERT SCREEN, WHICH IS ADVISING THE GENERATOR CANNOT DELIVER ENERGY. THEN THE "REPLACE INSTRUMENT" SCREEN WOULD BE DISPLAYED AFTER RECEIVING THE "CLOSE JAWS ON TISSUE AND REACTIVATE" MESSAGE THREE TIMES. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE BATCH NUMBER, AND NO NON-CONFORMANCES WERE IDENTIFIED. AS PART OF THE QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. NO CONCLUSION COULD BE REACHED ON THE CAUSE OF THE REPORTED EVENT. PLEASE REFER TO THE IFU FOR PROPER HANDLING OF THE DEVICE, NOTE THAT ¿CAUTION: DO NOT GRASP TISSUE BEYOND THE ELECTRODE SURFACE, IN THE HINGE OF THE JAWS. DO NOT OVERFILL THE JAWS OF THE INSTRUMENT WITH TISSUE. THIS COULD RESULT IN DIFFICULTY OPENING THE JAWS, PARTIALLY CUTTING TISSUE, AND UNINTENDED INJURY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THE ENSEAL´S JAW WAS BROKEN. THERE WAS NO SURGICAL DELAYED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO PATIENT CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2298070 ENSEAL X1 CURVED 37CM SHAFT ELECTROSURGICAL CUTTING & COAGULATION & ACCESSORIES GEI ETHICON ENDO-SURGERY, LLC. NSLX137C 20705036015465

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown GENERATOR.