BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDO GIA

    MDR report key: 23001301 · Received September 9, 2025

    Report

    Report Number
    1219930-2025-03963
    Event Type
    Malfunction
    Date Received
    September 9, 2025
    Date of Event
    August 28, 2025
    Report Date
    November 21, 2025
    Manufacturer
    SURGICAL
    Product Code
    GDW
    UDI-DI
    10884523002836
    PMA / PMN Number
    K111825
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D10 CONCOMITANT PRODUCT: 030452, 030452 ENDO GIA R/OR 30 3.5MM (LOT# T1M163X) 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: D4 (UDI #), D9, G3, H3, H6. H3 EVALUATION SUMMARY: MEDTRONIC CONDUCTED AN INVESTIGATION BASED UPON ALL INFORMATION RECEIVED. THE DEVICE WAS AVAILABLE FOR EVALUATION. VISUAL INSPECTION NOTED THAT THE LOADING UNIT WAS PARTIALLY FIRED WITH THE INTERLOCK ENGAGED. THE JAWS WERE OPEN. STAPLE PUSHERS WERE VISIBLE BETWEEN THE 3CM AND 2CM CUT LINES. FUNCTIONAL TESTING FOUND THAT THE LOADING UNIT WAS LOADED INTO A REPRESENTATIVE INSTRUMENT (0795). THE INTERLOCK WAS OVERRIDDEN AND THE LOADING UNIT WAS APPLIED TO TEST MEDIA. ALL REMAINING STAPLES WERE PLACED AND TEST MEDIA WAS CLEANLY TRANSECTED. THE LOADING UNIT INTERLOCK WAS TESTED AND FOUND TO FUNCTION PROPERLY. IT WAS REPORTED THAT THE DEVICE DID NOT FIRE COMPLETELY. THE REPORTED ISSUE WAS CONFIRMED. THE PRODUCT ANALYSIS NOTED EVIDENCE THAT THE DEVICE WAS NOT USED AS INTENDED. THIS ISSUE MAY OCCUR WHEN THE FIRING HANDLE HAS NOT BEEN COMPLETELY CYCLED. IF THE INSTRUMENT RETURN KNOBS ARE RETRACTED AT ANY POINT ONCE THE FIRING CYCLE HAS BEGUN, THE LOADING UNIT WILL ENGAGE INTO SAFETY INTERLOCK AND PREVENT FURTHER ATTEMPTS TO FIRE BY CEASING THE PLACEMENT OF STAPLES AND TISSUE TRANSECTION, AND PREVENT PATIENT HARM. 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: IN ORDER TO FIRE THE INSTRUMENT, PUSH THE GREEN BUTTON. SQUEEZE THE HANDLE SEQUENTIALLY UNTIL THE OVAL CLAMP COVER REACHES THE DISTAL END OF THE CARTRIDGE SLOT, AND THE HANDLE LOCKS. SEQUENTIAL SQUEEZES OF THE HANDLE ARE REQUIRED TO FULLY FIRE THE LOADING UNIT. THE TOTAL NUMBER OF SQUEEZES IS RELATIVE TO THE LENGTH OF THE LOADING UNIT (30, 45 OR 60). FAILURE TO COMPLETELY FIRE THE LOADING UNIT WILL RESULT IN AN INCOMPLETE CUT AND/OR INCOMPLETE STAPLE FORMATION, WHICH MAY RESULT IN POOR HEMOSTASIS. 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 RESECTION OF THE ZENKER DIVERTICULUM, A PARTIAL FIRE WAS OBSERVED IN WHICH THE RELOAD WAS FIRED TO 60%, AND THE REMAINDER WAS NOT FIRED AND DID NOT CUT. THE RELOAD WAS REPLACED WITH A SECOND ONE, WHICH EXHIBITED THE SAME ISSUES. THE THIRD AND FOURTH RELOADS FUNCTIONED AS INTENDED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2068845 ENDO GIA STAPLE, IMPLANTABLE GDW SURGICAL 030452 T1M163X 10884523002836

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown SEE H11.