BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRI-STAPLE 2.0

    MDR report key: 19801608 · Received July 22, 2024

    Report

    Report Number
    1219930-2024-03302
    Event Type
    Malfunction
    Date Received
    July 22, 2024
    Date of Event
    June 25, 2024
    Report Date
    September 18, 2024
    Manufacturer
    COVIDIEN LP LLC NORTH HAVEN
    Product Code
    GDW
    UDI-DI
    10884521717626
    PMA / PMN Number
    K173270
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    D10 CONCOMITANT PRODUCT: SIGPHANDLE, SIG POWER SIGPHANDLE HANDLE (LOT#: UNKNOWN); SIGPSHELL, SIG POWER SIGPSHELL CONTROL SHELL (LOT#: UNKNOWN); SIGADAPTSTND, SIG POWER SIGADAPTSTND LINEAR ADAPTER (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.

    Additional Manufacturer Narrative · 0

    EVALUATION SUMMARY: MEDTRONIC CONDUCTED AN INVESTIGATION BASED UPON ALL INFORMATION RECEIVED. THE DEVICE WAS AVAILABLE FOR EVALUATION. VISUAL INSPECTION NOTED THAT THE RELOAD WAS PARTIALLY FIRED AND THE INTERLOCK WAS ENGAGED. FUNCTIONAL TESTING FOUND THAT THE RELOAD WAS LOADED INTO A HANDLE, AND THE CLAMPING MECHANISM WAS DEFORMED. IT WAS REPORTED THAT DURING A LAPAROSCOPIC DISTAL GASTRECTOMY (LDG), THE FIRST GASTRECTOMY FIRING FROM THE GREATER CURVATURE SIDE, THE DEVICE STOPPED AROUND MIDWAY. THE USER REMOVED THE MIDDLE OF THE REINFORCE SHEET AND REMOVED THE CARTRIDGE FROM THE STOMACH. THE REPORTED ISSUE WAS CONFIRMED. THE PRODUCT ANALYSIS NOTED EVIDENCE THAT THE DEVICE WAS NOT USED AS INTENDED. 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 RELOAD WILL RESULT IN AN INCOMPLETE CUT AND/OR INCOMPLETE STAPLE FORMATION, WHICH MAY RESULT IN POOR HEMOSTASIS AND/OR LEAKAGE. ALWAYS INSPECT THE TISSUE THICKNESS AND SELECT AN APPROPRIATE STAPLE SIZE PRIOR TO APPLICATION OF THE ENDO GIA ULTRA UNIVERSAL SHORT, ENDO GIA ULTRA UNIVERSAL OR ENDO GIA ULTRA UNIVERSAL XL STAPLER. OVERLY THICK OR THIN TISSUE MAY RESULT IN UNACCEPTABLE STAPLE FORMATION. WHEN POSITIONING THE STAPLER ON THE APPLICATION SITE, ENSURE THAT NO OBSTRUCTIONS, SUCH AS CLIPS, ARE INCORPORATED INTO THE INSTRUMENT JAWS. FIRING OVER AN OBSTRUCTION MAY RESULT IN INCOMPLETE CUTTING ACTION AND/OR IMPROPERLY FORMED STAPLES. 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 LAPAROSCOPIC DISTAL GASTRECTOMY (LDG), THE FIRST GASTRECTOMY FIRING FROM THE GREATER CURVATURE SIDE, THE DEVICE STOPPED AROUND MIDWAY. THE USER REMOVED THE MIDDLE OF THE REINFORCE SHEET AND REMOVED THE CARTRIDGE FROM THE STOMACH. A NEW RELOAD WAS USED TO RESOLVED THE ISSUE. NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2482637 TRI-STAPLE 2.0 STAPLE, IMPLANTABLE GDW COVIDIEN LP LLC NORTH HAVEN SIGTRSB60AMT N4C1866Y 10884521717626

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown