BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    E-Z CLN L-WR LAP SPLIT STEM 33CM

    MDR report key: 23804709 · Received December 15, 2025

    Report

    Report Number
    1721194-2025-00078
    Event Type
    Malfunction
    Date Received
    December 15, 2025
    Date of Event
    November 30, 2025
    Report Date
    December 15, 2025
    Manufacturer
    MEGADYNE MEDICAL PRODUCTS, INC.
    Product Code
    GEI
    UDI-DI
    10614559100677
    PMA / PMN Number
    K913281
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). DATE SENT: 12/15/2025. D4 BATCH #: UNKNOWN. D4: UDI: THE EXPIRATION DATE IS CURRENTLY NOT AVAILABLE. THEREFORE, THE FULL UDI IS CURRENTLY NOT AVAILABLE. ATTEMPTS HAVE BEEN MADE TO RETRIEVE THE DEVICE. TO DATE THE DEVICE HAS NOT BEEN RETURNED. IF THE DEVICE OR FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. A MANUFACTURING RECORD EVALUATION IS PENDING FOR THE FINISHED DEVICE LOT NUMBER. 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: 2/20/2026. AN ANALYSIS OF THE PRODUCT COULD NOT BE PERFORMED SINCE A PHYSICAL SAMPLE WAS NOT RECEIVED FOR EVALUATION. THE LOT/BATCH HISTORY RECORDS WERE REVIEWED AND CERTIFIED BY EXTERNAL MANUFACTURING THAT THE MANUFACTURING CRITERIA WERE MET PRIOR TO THE RELEASE OF THE EQUIPMENT. THE CERTIFICATE RECORDS ARE ACCESSIBLE THROUGH EXTERNAL MANUFACTURING. AS PART OF OUR COMPANY QUALITY SYSTEM PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND DISTRIBUTED TO APPROVED SPECIFICATIONS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE A PIECE OF THE INSULATED TIP BROKE OFF (THE INSULATION PART NOT THE TIP). NOTICED DURING PROCEDURE BUT PRIOR TO USE IN PATIENT. NO PATIENT ADVERSE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    766432 E-Z CLN L-WR LAP SPLIT STEM 33CM E-Z CLEAN WIRE L-WIRE LAP SPLIT STEM 33 CM GEI MEGADYNE MEDICAL PRODUCTS, INC. A98U8X 10614559100677

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown