BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GOLD RELOAD FOR ECHELON 60

    MDR report key: 11108201 · Received January 4, 2021

    Report

    Report Number
    3005075853-2021-00002
    Event Type
    Injury
    Date Received
    January 4, 2021
    Date of Event
    December 7, 2020
    Report Date
    December 7, 2020
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    UDI-DI
    10705036011842
    PMA / PMN Number
    K051002
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DATE SENT: 1/4/2021. 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. ATTEMPTS ARE BEING MADE TO OBTAIN THE FOLLOWING INFORMATION. TO DATE NO RESPONSE HAS BEEN PROVIDED. IF FURTHER DETAILS ARE RECEIVED AT A LATER DATE, A SUPPLEMENTAL MEDWATCH WILL BE SENT. WHAT COLOR CARTRIDGES WERE USED AND THE ANATOMICAL LOCATION? WAS BUTTRESSING MATERIAL USED? WAS THE STAPLING ISSUE ON THE POUCH, J-J OR G-J? PLEASE DESCRIBE STAPLE FORM. WAS THE DEVICE DIFFICULT TO CLOSE OR FIRE? DOES THE SURGEON ROUTINELY WAIT 15 SECONDS PRIOR TO FIRING? ARE ANY PHOTOS OR VIDEO AVAILABLE? WAS THE EXTENDED HOSPITALIZATION DUE TO ISSUES WITH STAPLER OR OTHER FACTORS? HOW MUCH LONGER STAY WAS REQUIRED? WHAT IS THE CURRENT PATIENT STATUS? 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 · 1

    IT WAS REPORTED THAT THE CLIPS OF THE RELOAD ECR60 OPENED RIGHT AFTER THE STAPLING (INTRA-OPERATIVE) IN A BARIATRIC SURGERY THAT HAPPENED ON (B)(6) 2020. THE SURGEON HAD TO MANUALLY SUTURE IN ORDER TO STOP THE BLEEDING AND COMPLETE THE ANASTOMOSIS. THE SURGERY WAS SUCCESSFULLY COMPLETED, BUT THE PATIENT IS STILL UNDER OBSERVATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    5173 GOLD RELOAD FOR ECHELON 60 STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. ECR60D 10705036011842

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization