BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECHELON 60MM REINFORCEMENT

    MDR report key: 11739681 · Received April 28, 2021

    Report

    Report Number
    3005075853-2021-02351
    Event Type
    Malfunction
    Date Received
    April 28, 2021
    Report Date
    April 2, 2021
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    OXC
    UDI-DI
    10705036023296
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). BATCH # UNK. AS THE DEVICE WAS NOT RETURNED, AN ANALYSIS INVESTIGATION COULD NOT BE PERFORMED. A CONCLUSION COULD NOT BE REACHED AS TO WHAT MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT. WE DID NOT RECEIVE A BATCH OR LOT NUMBER FOR THE PRODUCT INVOLVED IN THIS COMPLAINT. THEREFORE, WE WERE UNABLE TO CHECK MANUFACTURING RECORDS FOR ANY RELATED NON-CONFORMANCE. ADDITIONAL INFORMATION RECEIVED: THE SURGEON JUST WANTED ME TO REPORT WHAT I STATED BELOW. WHEN THE SURGEON USES SLR /GST 60MM RELOADS TOGETHER EACH FIRING ON THE SLEEVE GASTRECTOMY IS NOT BEING PLACED WITHIN THE CROTCH OF EACH CONSECUTIVE FIRING BUT INSTEAD BEING FIRED THROUGH PREVIOUS STAPLE LINE AND THAT¿S WHEN HE IS SEEING STRAIGHTENING OF PREVIOUS STAPLES OR OBSERVING CUT STAPLES WHEN THE KNIFE BLADE CUTS THROUGH THEM. WE HAVEN¿T SEEN THIS AFTER SEVERAL ADDITIONAL CASES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SURGEON STATED THAT WHILE USING OUR STAPLE LINE REINFORCEMENT HE HAS BEEN SEEING AN INCREASE IN ¿SHARP¿ STAPLES. THAT WHEN THE KNIFE BLADE PUSHED THROUGH AND COMES IN CONTACT WITH PREVIOUS STAPLE LINE THAT THE BLADE IS EITHER CUTTING OR PUSHING OPEN THE STAPLES. SURGEON STATED WITH HE WAS NOT SEEING THIS WHILE USING A COMPETITORS STAPLE LINE REINFORCEMENT. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    635281 ECHELON 60MM REINFORCEMENT SURGICAL MESH OXC ETHICON ENDO-SURGERY, LLC. 10705036023296

    Patients

    Seq Age Sex Outcome Treatment
    1