BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ETHICON 4000 STAPLER STRAIGHT 60 STANDARD

    MDR report key: 23950382 · Received January 2, 2026

    Report

    Report Number
    3005075853-2026-00040
    Event Type
    Malfunction
    Date Received
    January 2, 2026
    Date of Event
    December 15, 2025
    Report Date
    January 2, 2026
    Manufacturer
    GDW
    Product Code
    GDW
    UDI-DI
    10705036043522
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). DATE SENT: 1/2/2026. D4: BATCH#: UNK. D4: UDI: AS THE LOT NUMBER FOR THE DEVICE INVOLVED IN THE EVENT WAS NOT PROVIDED, THE FULL UDI IS CURRENTLY NOT AVAILABLE. D4: UDI: THE EXPIRATION DATE IS CURRENTLY NOT AVAILABLE. THEREFORE, THE FULL UDI IS CURRENTLY NOT AVAILABLE. H4: THE DEVICE MANUFACTURE DATE IS CURRENTLY NOT AVAILABLE. 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: WAS THE FIRING SEQUENCE STARTED BUT NOT COMPLETED? IF YES: DID THE DEVICE DELIVER ANY STAPLES? IF YES, WERE THE STAPLES FORMED PROPERLY? IF YES, WAS THE STAPLE LINE COMPLETE? DID THE DEVICE CUT? IF YES, WAS THE CUT LINE COMPLETE? IF YES, WAS THERE ANY ISSUE WITH THE CUT LINE? WAS THERE ANY DIFFICULTY OPENING THE DEVICE JAWS? NO LOT OR BATCH NUMBER WAS PROVIDED; THEREFORE, A DEVICE HISTORY COULD NOT BE DONE. 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: 1/13/2026. D4: BATCH #UNK. ADDITIONAL INFORMATION WAS REQUESTED, AND THE FOLLOWING WAS OBTAINED: DEVICE WAS FIRED AND COMPLETED. STAPLES WERE DELIVERED. STAPLES WERE PROPERLY FORMED OTHER THAN THE STAPLES LIED DOWN AT THE CROTCH OF THE STAPLER AT THE SUBSEQUENT FIRINGS. STAPLE LINE COMPLETE. DEVICE DID CUT. CUT LINE COMPLETE. NO ISSUES WITH THE CUT LINE. NO DIFFICULTY OPENING THE JAWS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A SLEEVE GASTRECTOMY PROCEDURE, AFTER THE FIRST FIRING IT SEEMED THAT THE SURGEON KIND OF OVERLAPPED THE PREVIOUS STAPLE LINES WITH EACH SEQUENTIAL FIRING AND THE STAPLES DID NOT PROPERLY GO INTO THE TISSUE AND WERE KIND OF HANGING OFF AT THE BEGINNING OF EACH STAPLE LINE. THERE WERE NO ADVERSE CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    3111 ETHICON 4000 STAPLER STRAIGHT 60 STANDARD STAPLE, IMPLANTABLE GDW GDW 10705036043522

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown