BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GOLD RELOAD FOR ECHELON 45

    MDR report key: 16890467 · Received May 8, 2023

    Report

    Report Number
    3005075853-2023-03146
    Event Type
    Malfunction
    Date Received
    May 8, 2023
    Date of Event
    April 14, 2023
    Report Date
    June 15, 2023
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    UDI-DI
    10705036001737
    PMA / PMN Number
    K051002
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). DATE SENT: 5/8/2023. BATCH # UNK. THE LOT/BATCH HISTORY RECORDS WERE REVIEWED AND CERTIFIED BY EXTERNAL MANUFACTURING THAT THE MANUFACTURING CRITERIA WERE MET PRIOR TO THE RELEASE OF THE EQUIPMENT. THE CERTIFICATE RECORDS ARE ACCESSIBLE THROUGH EXTERNAL MANUFACTURING. 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. 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.

    Additional Manufacturer Narrative · 0

    (B)(4). DATE SENT: 6/15/2023. D4: BATCH # UNK. ADDITIONAL INFORMATION: ACCORDING TO FEEDBACK (B)(6) 2023 VIA PHONE, THE EVENT DATE SHOULD BE 14-APR-2023.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING THE SURGERY, FOUND THE CARTRIDGE PAN HAS DAMAGED ON THE 1TH FIRING. CHANGED ANOTHER ONE TO CONTINUE THE SURGERY, AFTER FIRED, NOTED THE STAPLES MALFORMED. CHANGED THE NEW ONE TO COMPLETE SURGERY. THERE WAS NO PATIENT CONSEQUENCE REPORTED. NO ADDITIONAL INFORMATION CAN BE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1954998 GOLD RELOAD FOR ECHELON 45 STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. ECR45D 955A84 10705036001737

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Unknown