BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ETHICON SECURESTRAP 5MM ABSORBABLE STRAP FIXATION DEVICE

    MDR report key: 20358895 · Received October 3, 2024

    Report

    Report Number
    2210968-2024-10467
    Event Type
    Malfunction
    Date Received
    October 3, 2024
    Date of Event
    June 12, 2024
    Manufacturer
    ETHICON INC.
    Product Code
    GDW
    UDI-DI
    10705031132993
    PMA / PMN Number
    K093845
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). 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 INC, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, ETHICON INC, 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. 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. H6 COMPONENT CODE: G07002 ¿ DEVICE NOT RETURNED. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER, AND NO RELATED NON-CONFORMANCES WERE IDENTIFIED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2024 AND ABSORBABLE STRAPS WERE USED. DURING THE USE OF THE STAPLER IN SURGICAL PROCEDURE, WHEN PULLING THE TRIGGER, HE BEGAN TO RELEASE SEVERAL STAPLES, AND IT WAS NECESSARY TO DISPENSE ANOTHER STAPLER TO FINISH THE SURGERY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1091831 ETHICON SECURESTRAP 5MM ABSORBABLE STRAP FIXATION DEVICE STAPLE, IMPLANTABLE GDW ETHICON INC. TMMAUK 10705031132993

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown