BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LAPRA-TY ABSORBABLE X6::SUTURE CLIP

    MDR report key: 18144866 · Received November 15, 2023

    Report

    Report Number
    2210968-2023-08875
    Event Type
    Malfunction
    Date Received
    November 15, 2023
    Date of Event
    October 24, 2023
    Report Date
    December 13, 2023
    Manufacturer
    ETHICON INC.
    Product Code
    FZP
    UDI-DI
    10705031206885
    PMA / PMN Number
    K931492
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(6) H6 COMPONENT CODE: G07002 - NO DEVICE PROBLEM FOUND. 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 INC, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, ETHICON INC 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. H3 INVESTIGATION SUMMARY: THE PRODUCT WAS RETURNED FOR EVALUATION. VISUAL INSPECTION WAS CONDUCTED ON THE RETURNED CARTRIDGE. VISUAL ANALYSIS OF THE RETURNED SAMPLES REVEALED THAT XC200 (G) CARTRIDGE WAS RECEIVED STERILE WITH NO APPARENT DAMAGE AND 6 CLIPS LOADED. THE CARTRIDGE WAS TESTED FOR FUNCTIONALITY WITH THE TEST DEVICE. UPON FUNCTIONAL TESTING OF THE CLIPS, THE INSTRUMENT LOADED, RETAINED, AND DEPLOYED SIX CLIPS AS INTENDED. THE CLIPS WERE AS INTENDED AND CONFORMS TO OUR MANUFACTURING REQUIREMENTS. AS PART OF ETHICON¿S QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. THE EVENT DESCRIBED COULD NOT BE CONFIRMED AS THE CLIP PERFORMED WITHOUT ANY DIFFICULTIES NOTED. ALTHOUGH NO PRODUCT DEFECT WAS IDENTIFIED, THERE MAY HAVE BEEN OTHER CIRCUMSTANCES OR ISSUES THAT OCCURRED DURING THE USE OF THE DEVICE THAT COULD NOT BE REPLICATED DURING THE LABORATORY ANALYSIS.

    Additional Manufacturer Narrative · 0

    (B)(4) 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 INC, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, ETHICON INC, 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 INFORMATION WAS REQUESTED AND THE FOLLOWING WAS OBTAINED: - PLEASE PROVIDE THE APPLIER PRODUCT CODE AND LOT NUMBER? - THE APPLIER CODE IS KA200 AND LOT NUMBER IS UNKNOWN.PLEASE CONFIRM IF THERE IS AN ISSUE WITH THE APPLIER? NO. IF YES, PLEASE CREATE A PRODUCT COMPLAINT AND PROVIDE THE RESPECTIVE REFERENCE NUMBER(S). N/A- WHEN THE EVENT OCCURRED, WAS THE SUTURE PLACED NEAR THE HINGE OF THE CLIP? CURRENTLY, UNKNWON.- WAS THE APPLIER CHECKED FOR DAMAGED (JAWS STRAIGHT AND ALIGNED)?CURRENTLY, UNKNOWN. - IF THE CLIP DID NOT CLOSE/HOLD ON THE SUTURE, WAS THE CLIP USED IN AN APPLICATION WHERE THE SUTURE WAS UNDER TENSION? =>CURRENTLY, UNKNOWN. ATTEMPTS ARE BEING 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. H6 COMPONENT CODE: G07002 ¿ DEVICE NOT RETURNED A REVIEW OF THE BATCH MANUFACTURING RECORDS WAS CONDUCTED, AND NO RELATED NON-CONFORMANCES WERE IDENTIFIED. RELATED EVENTS CAPTURED VIA 2210968-2023-08876, 2210968-2023-08877, 2210968-2023-08878, 2210968-2023-08879, 2210968-2023-08880, 2210968-2023-08881.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT A LAPAROSCOPIC KIDNEY AND ADRENAL GLAND PROCEDURE ON 24-OCT-2023 AND SUTURE CLIPS WERE USED. THE CLIP COULD NOT BE CLOSED. ONLY 2 CLIPS OUT OF A PACKAGE COULD BE USED. THE SUTURE WAS VICRYL 2-0, 3-0. THE DEVICE WAS USED ON THE KIDNEY. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2238536 LAPRA-TY ABSORBABLE X6::SUTURE CLIP CLIP, IMPLANTABLE FZP ETHICON INC. SK2AQS 10705031206885

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown