BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGACLIP

    MDR report key: 24272177 · Received February 5, 2026

    Report

    Report Number
    3005075853-2026-01066
    Event Type
    Malfunction
    Date Received
    February 5, 2026
    Date of Event
    January 1, 2026
    Report Date
    April 27, 2026
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDO
    UDI-DI
    10705036002499
    PMA / PMN Number
    K820837
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). DATE SENT: 4/27/2026. INVESTIGATION SUMMARY: THE PRODUCT WAS RETURNED TO EES FOR EVALUATION. VISUAL INSPECTIONS WERE CONDUCTED ON THE RETURNED DEVICE. VISUAL ANALYSIS OF THE RETURNED SAMPLE CONFIRMED RECEIPT OF THE MCS20 DEVICE. NO PACKAGING WAS RETURNED WITH THE DEVICE FOR ANALYSIS AND WERE THEREFORE UNAVAILABLE FOR ANALYSIS. UPON INSPECTION, FOREIGN MATERIAL WAS OBSERVED ON THE INSTRUMENT AND WAS SUBSEQUENTLY IDENTIFIED AS LUBRICANT. AS PART OF ETHICON¿S QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. THE LUBRICANT IS LUBRIPLATE SUPER FML-2 GREASE WHICH IS USED AS LUBRICATION ON THE INSIDE OF THE DEVICE AND IS ATTRIBUTABLE TO THE ASSEMBLY PROCESS. DEVICE HISTORY REVIEW: A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT 527D80 NUMBER, AND NO NON-CONFORMANCES WERE IDENTIFIED.

    Additional Manufacturer Narrative · 0

    (B)(4). DATE SENT: 3/5/2026. D4: BATCH # 527D80. INVESTIGATION SUMMARY: THIS IS AN ANALYSIS FOR A PHOTO SUBMITTED TO ETHICON FOR EVALUATION. DURING THE VISUAL ANALYSIS, THE FOLLOWING WAS OBSERVED: VISUAL ANALYSIS OF THE PHOTO REVEALED THAT THE MCS20 DEVICE INSIDE ITS PACKAGE UNOPENED. UPON VISUAL INSPECTION A FOREIGN MATTER WAS OBSERVED TO BE ON THE INSTRUMENT AND IT WAS CONFIRMED TO BE LUBRICANT. THE MATERIAL WAS COMPARED WITH THE GREASE THAT IS INSIDE OF THE HANDLE OF THE DEVICE AND WAS A GOOD MATCH. THE FOREIGN MATERIAL IDENTIFIED ON THE OUTSIDE OF THE SHROUD IS LUBRIPLATE SUPER FML-2 GREASE WHICH IS USED AS LUBRICATION ON THE INSIDE OF THE DEVICE. AS PART OF ETHICON¿S QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. THE LUBRICANT IS LUBRIPLATE SUPER FML-2 GREASE WHICH IS USED AS LUBRICATION ON THE INSIDE OF THE DEVICE AND IS ATTRIBUTABLE TO THE ASSEMBLY PROCESS. DEVICE HISTORY REVIEW: A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE 527D80_MCS20 BATCH NUMBER, AND NO NON-CONFORMANCES WERE IDENTIFIED.

    Additional Manufacturer Narrative · 0

    (B)(4) DATE SENT: 2/5/2026 B3: EXACT EVENT DATE UNK, ENTERED 1/1/2026 AS ONLY THE YEAR WAS PROVIDED. D4: BATCH # 527D80. 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 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 UNK PROCEDURE, THE DEVICE WAS CONTAMINATED ALREADY BEFORE OPENING. THE PATIENT AND OPERATION WERE FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    273233 LIGACLIP CLIP, IMPLANTABLE GDO ETHICON ENDO-SURGERY, LLC. 527D80 10705036002499

    Patients

    Seq Age Sex Outcome Treatment
    1