BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDO GIA ULTRA

    MDR report key: 23732480 · Received December 5, 2025

    Report

    Report Number
    2647580-2025-03595
    Event Type
    Malfunction
    Date Received
    December 5, 2025
    Date of Event
    October 16, 2025
    Report Date
    January 9, 2026
    Manufacturer
    COVIDIEN
    Product Code
    GDW
    UDI-DI
    10884523003543
    PMA / PMN Number
    K111825
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D10 CONCOMITANT PRODUCTS: 030425, 030425 ENDO GIAII 45 2.5MM DLU X6 (LOT#: P1M0586S) 030414, 030414 ENDO GIA UNI 60 3.5 DLU X6 (LOT#: P2D0285S). 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

    ADDITIONAL INFORMATION: G3, H3, H6 H3 EVALUATION SUMMARY: "MEDTRONIC CONDUCTED AN INVESTIGATION BASED UPON ALL INFORMATION RECEIVED. THE DEVICE WAS AVAILABLE FOR EVALUATION. THE EVALUATION D ETECTED AN UNREPORTED CONDITION OF SHEARED FIRING RACK TEETH. VISUAL EXAMINATION NOTED THAT THE INSTRUMENT FIRING KNOBS WERE RETRACTED. THE ARTICULATION LEVER WAS IN NEUTRAL POSITION. FUNCTIONAL TESTING FOUND THAT THE INSTRUMENT WAS SUCCESSFULLY LOADED WITH A RELOAD. DURING THE FIRING CYCLE, A SKIP WAS AUDIBLE IN THE FIRING STROKE. AN ACCESS HOLE WAS CUT INTO THE INSTRUMENT BODY FOR VISUALIZATION OF THE FIRING RACK. SHEARED TEETH WERE VISIBLE ON THE FIRING RACK. THE PRODUCT ANALYSIS NOTED EVIDENCE THAT THE DEVICE WAS NOT USED AS INTENDED. THIS ISSUE CAN OCCUR IN ANY OF THE FOLLOWING CIRCUMSTANCES: 1. FIRING OVER TISSUE THAT IS BEYOND THE RECOMMENDED THICKNESS RANGE. 2. FIRING WITH AN OBSTACLE INCORPORATED IN THE JAWS. 3. ATTEMPTING TO FIRE A RELOAD THAT IS IN INTERLOCK. IN EACH CIRCUMSTANCE, IT WILL BECOME INCREASINGLY DIFFICULT TO ACTUATE THE FIRING HANDLE AND THE INSTRUMENT RETURN KNOBS WILL BE DIFFICULT TO RETRACT. IN ADDITION, STAPLES MAY NOT FORM PROPERLY, AND TISSUE MAY NOT BE FULLY TRANSECTED. 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: 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. WHEN USING THE STAPLER MORE THAN ONCE DURING A SINGLE SURGICAL PROCEDURE, BE SURE TO REMOVE THE EMPTY ENDO GIA¿ SINGLE USE RELOAD AND LOAD A NEW ONE. A SAFETY INTERLOCK IS PROVIDED THAT PREVENTS AN EMPTY SINGLE USE RELOAD FROM BEING FIRED A SECOND TIME. DO NOT ATTEMPT TO OVERRIDE THE SAFETY INTERLOCK. OVERRIDING THE SAFETY INTERLOCK WILL CAUSE DEVICE MALFUNCTION. 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 THE SINGLE-PORT THORACOSCOPIC LEFT UPPER LOBECTOMY, WHEN TREATING THE LEFT UPPER LOBE VEIN, THE STAPLES BURST OUT AND FAILED TO FORM THE PROPER "B" SHAPE, RESULTING IN BLEEDING. ANOTHER RELOAD WAS USED FOR UPPER LOBE INTERLOBAR DETACHMENT BUT ENCOUNTERED THE SAME ISSUE, WITH AN INCOMPLETE STAPLE LINE OBSERVED IN THE MIDDLE. MANUAL SUTURING WAS SUBSEQUENTLY PERFORMED LAPAROSCOPICALLY TO RESOLVE THE ISSUE. THE SURGICAL TIME WAS EXTENDED FOR MORE THAN 30 MINUTES AS A RESULT. MEDTRONIC'S INITIAL EVALUATION OF THE INCIDENT FOUND THAT THERE WAS HANDLE TICK TISSUE. AN ACCESS HOLE WAS CUT INTO THE INSTRUMENT BODY FOR VISUALIZATION OF THE FIRING RACK. SHEARED TEETH WERE VISIBLE ON THE FIRING RACK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2168325 ENDO GIA ULTRA STAPLE, IMPLANTABLE GDW COVIDIEN EGIAUSTND P5C1367S 10884523003543

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Male SEE H11.