BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MULTIFIRE ENDO HERNIA

    MDR report key: 20935922 · Received December 16, 2024

    Report

    Report Number
    2647580-2024-05149
    Event Type
    Malfunction
    Date Received
    December 16, 2024
    Date of Event
    September 27, 2024
    Report Date
    December 15, 2024
    Manufacturer
    US SURGICAL PUERTO RICO
    Product Code
    GCJ
    PMA / PMN Number
    K912097
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    D10 CONCOMITANT MEDICAL PRODUCTS: 173054, 173054 ENDO UNI 12 WITH (LOT#:P3A0337) 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

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC INGUINAL HERNIA REPAIR USING THE ENDO HERNIA DEVICE, THE STAPLER BLOCKED DURING MESH FIXATION. THE ISSUE WAS RESOLVED BY THE SURGEON USING ANOTHER ENDO HERNIA DEVICE TO COMPLETE THE CASE. THERE WERE NO INJURIES OR COMPLICATIONS REPORTED, AND NO ADDITIONAL OPERATIONS WERE PLANNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2390415 MULTIFIRE ENDO HERNIA LAPAROSCOPE, GENERAL & PLASTIC SURGERY GCJ US SURGICAL PUERTO RICO 174007 P4E1063

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown