BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWERED 60 ECHELON +, 340MM SHAFT

    MDR report key: 16464212 · Received March 1, 2023

    Report

    Report Number
    3005075853-2023-01270
    Event Type
    Malfunction
    Date Received
    March 1, 2023
    Date of Event
    January 1, 2023
    Report Date
    March 1, 2023
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    UDI-DI
    10705036014607
    PMA / PMN Number
    K110385
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). BATCH # UNK. DATE OF EVENT IS 2023, EVENT DAY AND MONTH UNKNOWN. CAPTURED AS (B)(6) 2023. ADDITIONAL INFORMATION WAS REQUESTED, AND THE FOLLOWING WAS OBTAINED: (B)(6) PERFORMED BARIATRIC SURGERY AND AT ONE OF THE ANASTOMOSES (GBP) THE TISSUE WAS SO THICK THAT THE UPPER LEG OF PSEE60A BENT HIMSELF/"JUMPED OUT OF LINE". IT WAS STILL ABLE TO LOAD MAGAZINES BUT COULDN'T GET IT BACK INTO THE TROCAR. HAD TO CHANGE INSTRUMENTS. (B)(6) WILL RETURN WITH MORE FACTS ABOUT INSTRUMENTS AND EVENT DESCRIPTION. EVENT OCCURED SOMETIME IN JAN ((B)(6) WILL COME BACK) ALERT DATE (B)(6). AN EVALUATION OF THE MANUFACTURING RECORD COULD NOT BE PERFORMED AS THE REQUIRED PRODUCT IDENTIFICATION NUMBER WAS NOT PROVIDED TO COMPLETE THE EVALUATION. 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. 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, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, ETHICON, 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE SURGEON PERFORMED BARIATRIC SURGERY AND AT ONE OF THE ANASTOMOSES (GBP) THE TISSUE WAS SO THICK THAT THE UPPER LEG OF PSEE60A BENT AND JUMPED OUT OF LINE. IT WAS STILL ABLE TO LOAD MAGAZINES BUT COULDN'T GET IT BACK INTO THE TROCAR. HAD TO CHANGE INSTRUMENTS. NO PATIENT CONSEQUENCES REPORTED. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1436298 POWERED 60 ECHELON +, 340MM SHAFT STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. PSEE60A 10705036014607

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown