BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDO UNIVERSAL 65

    MDR report key: 21532046 · Received March 5, 2025

    Report

    Report Number
    2647580-2025-00731
    Event Type
    Malfunction
    Date Received
    March 5, 2025
    Date of Event
    February 12, 2025
    Report Date
    March 5, 2025
    Manufacturer
    US SURGICAL PUERTO RICO
    Product Code
    GCJ
    UDI-DI
    10884521070530
    PMA / PMN Number
    K912097
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    D10: CONCOMITANT PRODUCTS: 173054, 173054 ENDO UNI 12 WITH (LOT UNKNOWN). MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Description of Event or Problem · 0

    ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE DEVICE FIRE INITIALLY, BUT AFTER FIVE TO TEN STAPLES THE STAPLER JAMMED AND DID NOT FIRE OUT. ADDITIONALLY, IT WOULD PUT OUT TWO STAPLES AT A TIME EVERY ONCE IN A WHILE. THIS ISSUE OCCURRED WITH A 4 MILLIMETER (MM) AND 4.8 MM STAPLE. TO RESOLVE THE ISSUE, A THIRD STAPLER WAS USED. THERE WAS NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    434823 ENDO UNIVERSAL 65 LAPAROSCOPE, GENERAL & PLASTIC SURGERY GCJ US SURGICAL PUERTO RICO 173052 10884521070530

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown SEE H11