BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRI-STAPLE 2.0

    MDR report key: 20190562 · Received September 11, 2024

    Report

    Report Number
    1219930-2024-04166
    Event Type
    Malfunction
    Date Received
    September 11, 2024
    Date of Event
    August 20, 2024
    Report Date
    December 6, 2024
    Manufacturer
    COVIDIEN LP LLC NORTH HAVEN
    Product Code
    GDW
    UDI-DI
    10884521543584
    PMA / PMN Number
    K160176
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D10 CONCOMITANT PRODUCT: SIGC60MT, TRI 2.0 SIGC60MT 60 MED THK CARTRIDGE (LOT#: N2M0255Y) SIGC60MT, TRI 2.0 SIGC60MT 60 MED THK CARTRIDGE (LOT#: N3A0343Y) SIGPHANDLE, SIG POWER SIGPHANDLE HANDLE (SERIAL#: UNKNOWN) SIGADAPTXL, SIG POWER SIGADAPTXL LINEAR XL ADAPTER (SERIAL#: 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. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Additional Manufacturer Narrative · 0

    MEDTRONIC CONDUCTED AN INVESTIGATION BASED UPON ALL INFORMATION RECEIVED. THE DEVICE WAS AVAILABLE FOR EVALUATION. VISUAL INSPECTION NOTED THAT THE STAPLE CARTRIDGE WAS PARTIALLY FIRED. STAPLE PUSHERS WERE VISIBLE AT THE 4CM CUT LINE. FUNCTIONALLY, THE CARTRIDGE WAS LOADED INTO A REPRESENTATIVE HANDLE, ADAPTER, AND LOADING UNIT. A MOISTURE ERROR OCCURRED ON THE HANDLE SCREEN. THE CARTRIDGE WAS REMOVED AND REATTACHED. THE CARTRIDGE WAS RECOGNIZED AS NEW. IT WAS REPORTED THAT THE DEVICE FIRED PARTIALLY. THE REPORTED ISSUE WAS CONFIRMED. THE MOST LIKELY CAUSE COULD NOT BE ESTABLISHED FROM THE INFORMATION AVAILABLE. THE MANUFACTURING RECORDS FOR EACH DEVICE ARE THOROUGHLY REVIEWED PRIOR TO RELEASE TO ENSURE THAT IT MEETS ALL MEDTRONIC QUALITY SPECIFICATIONS. THE INSTRUCTIONS INCLUDED WITH THIS DEVICE PROVIDE THE FOLLOWING GUIDANCE: FAILURE TO COMPLETELY FIRE THE LOADING UNIT/CARTRIDGE WILL RESULT IN AN INCOMPLETE CUT AND/OR INCOMPLETE STAPLE FORMATION, WHICH MAY RESULT IN POOR HEMOSTASIS AND/OR LEAKAGE. 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 SLEEVE PLUS PROCEDURE, WHEN FIRING ON THE STOMACH, IT STUCK IN BETWEEN. IT WAS NOTED THAT RELOADS STOPPED FIRING HALFWAY, AND IT OCCURRED ON THREE RELOADS. THE RELOAD WAS REPLACED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    538113 TRI-STAPLE 2.0 STAPLE, IMPLANTABLE GDW COVIDIEN LP LLC NORTH HAVEN SIGC60MT N3A0343Y 10884521543584

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown SEE NOTE ON H11.