BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENSEAL X1 CURVED 37CM SHAFT

    MDR report key: 17370470 · Received July 21, 2023

    Report

    Report Number
    3005075853-2023-05162
    Event Type
    Malfunction
    Date Received
    July 21, 2023
    Date of Event
    June 12, 2023
    Report Date
    July 21, 2023
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GEI
    UDI-DI
    10705036015468
    PMA / PMN Number
    K172580
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). DATE SENT: 7/21/2023. D4 BATCH #: UNKNOWN. ADDITIONAL INFORMATION WAS REQUESTED AND THE FOLLOWING WAS OBTAINED: DID THE ELECTRODE CERAMIC SEPARATE OR BREAK OFF? NO. DID THE KNIFE GET DAMAGED OR BREAK OFF? NO. IS THE JAW DAMAGED BUT NOT BROKEN OFF? NO. IS THE JAW LOOSE BUT NOT DETACHED? NO. IS THE TOP JAW BROKEN OFF THE OF THE DEVICE? YES. AN ANALYSIS OF THE PRODUCT COULD NOT BE PERFORMED SINCE A PHYSICAL SAMPLE WAS NOT RECEIVED FOR EVALUATION. AS PART OF OUR COMPANY QUALITY SYSTEM PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND DISTRIBUTED TO APPROVED SPECIFICATIONS. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER, AND NO NON-CONFORMANCE WERE IDENTIFIED. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THE JOINT WAS BROKEN. THERE WERE NO PATIENT CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1893723 ENSEAL X1 CURVED 37CM SHAFT ELECTROSURGICAL CUTTING & COAGULATION & ACCESSORIES GEI ETHICON ENDO-SURGERY, LLC. NSLX137C X95G6N 10705036015468

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown GENREATOR