BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECHELON 60MM REINFORCEMENT

    MDR report key: 14575459 · Received June 2, 2022

    Report

    Report Number
    3005075853-2022-03553
    Event Type
    Malfunction
    Date Received
    June 2, 2022
    Date of Event
    May 13, 2022
    Report Date
    June 24, 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. AN EVALUATION OF THE MANUFACTURING RECORD COULD NOT BE PERFORMED AS THE REQUIRED PRODUCT IDENTIFICATION NUMBER WAS NOT PROVIDED TO COMPLETE THE EVALUATION 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. ADDITIONAL INFORMATION WAS REQUESTED, AND THE FOLLOWING WAS OBTAINED: IS THE CURRENT PATIENT STATUS KNOWN? ¿ NOT THAT WE ARE AWARE. WAS THERE ANY PATIENT CONSEQUENCE OR CHANGE IN THE POST-OPERATIVE CARE OF THE PATIENT AS A RESULT OF THE EVENT? (EXTENDED HOSPITAL STAY, READMISSION, RE-OPERATION, ETC.) ¿ NOT THAT WE ARE AWARE.

    Additional Manufacturer Narrative · 0

    (B)(4). DATE SENT: 6/24/2022. 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 AN INDIVIDUAL 1-UP CARTON (A) WAS RETURNED AND ONE EMPTY 6-UP CARTON WERE RETURNED. THE TEMPERATURE INDICATOR STICKERS ON CARTON AND THE 6-UP CARTON HAD BEEN TRIGGERED AND WERE PINK, INDICATED THAT THE PACKAGE WAS SUBJECTED TO A TEMPERATURE IN EXCESS OF 50°. THE DEVICE WAS OPENED AND VISUALLY INSPECTED FOR DAMAGE TO THE BUTTRESS ATTACHMENT MATERIAL (BAM) PATTERN. UPON VISUAL INSPECTION SHOWED VISIBLE SIGNS OF HIGH TEMPERATURE WITH A MELTED AND MIGRATING BAM PATTERN. 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. NO CONCLUSION COULD BE REACHED ON WHAT MAY HAVE CAUSED THE REPORTED INCIDENT. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT/ BATCH NUMBER, AND NO NON-CONFORMANCES RELATED TO THE REPORTED COMPLAINT CONDITION WERE IDENTIFIED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT ON THE ECH60R THE STICKER WAS PINK. THERE WERE THREE THAT WERE NOTICED WHEN THE PRODUCT WAS BEING PUT AWAY AFTER A CASE. NO PATIENT CONSEQUENCES REPORTED. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2413710 ECHELON 60MM REINFORCEMENT OXC OXC ETHICON ENDO-SURGERY, LLC. ECH60R RBCCMSS0 10705036023296

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown