BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECHELON 60MM REINFORCEMENT

    MDR report key: 14142529 · Received April 19, 2022

    Report

    Report Number
    3005075853-2022-02488
    Event Type
    Malfunction
    Date Received
    April 19, 2022
    Date of Event
    March 21, 2022
    Report Date
    May 25, 2022
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    OXC
    UDI-DI
    10705036023296
    PMA / PMN Number
    K190937
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). BATCH # UNK.

    Additional Manufacturer Narrative · 0

    (B)(4). DATE SENT: 5/25/2022. INVESTIGATION SUMMARY. THE PRODUCT WAS RETURNED TO ETHICON ENDO-SURGERY FOR EVALUATION. VISUAL INSPECTION WAS CONDUCTED ON THE RETURNED APPLICATOR. VISUAL ANALYSIS OF THE RETURNED SAMPLE DETERMINED THAT TEN LOOSE, UNOPENED 1-UP CARTONS WERE RETURNED; THE TEMPERATURE INDICATOR STICKER ON THE 1-UP SALES CARTON (I) HAD BEEN TRIGGERED AND WAS PINK, INDICATED THAT THE PACKAGE WAS SUBJECTED TO A TEMPERATURE IN EXCESS OF 50°. 1-UP CARTON ALSO HAD TRIGGERED TEMPERATURE STICKERS WITH NO OTHER VISIBLE DAMAGE. THE APPLICATOR WAS OPENED AND VISUALLY INSPECTED FOR DAMAGE TO THE BUTTRESS ATTACHMENT MATERIAL (BAM) PATTERN WAS FOUND TO BE APPEAR CONFORMING. THIS WOULD INDICATE THAT WHILE SOME OF THE PACKAGES MAY HAVE BEEN SUBJECTED TO ELEVATED TEMPERATURES AT OR ABOVE 50°C, THE TEMPERATURE WAS LIKELY STILL BELOW THE ACTUAL MELTING POINT OF THAT PARTICULAR BATCH. NO CONCLUSION COULD BE REACHED ON WHAT MAY HAVE CAUSED THE REPORTED INCIDENT. AS PART OF OUR QUALITY PROCESS, THE MANUFACTURING RECORDS OF THIS BATCH NUMBER WERE REVIEWED, AND THE MANUFACTURING STANDARDS WERE MET PRIOR TO THE RELEASE OF THIS BATCH. AS PART OF ETHICON ENDO SURGERY¿S QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING THE SLEEVE GASTRECTOMY, THEY WERE OPENING THE DEVICE WHEN THEY REALIZED THE TEMPERATURE INDICATOR TRAVELED OUTSIDE OF THE APPROPRIATE TEMPERATURE. NEW DEVICES USED COMPLETE THE PROCEDURE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2717343 ECHELON 60MM REINFORCEMENT OXC OXC ETHICON ENDO-SURGERY, LLC. ECH60R RBCCMSS0 10705036023296

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown