BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDO GIA

    MDR report key: 19843559 · Received July 26, 2024

    Report

    Report Number
    1219930-2024-03360
    Event Type
    Injury
    Date Received
    July 26, 2024
    Date of Event
    July 2, 2024
    Report Date
    September 18, 2024
    Manufacturer
    COVIDIEN LP LLC NORTH HAVEN
    Product Code
    GDW
    UDI-DI
    10884523003178
    PMA / PMN Number
    K111825
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D10 CONCOMITANT PRODUCTS: EGIAUSTND - EGIAUSTND ENDOGIA ULTRA UNIV STD STAP, LOT# P2K0038. 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: D9, G3, H3, H6 H3 EVALUATION SUMMARY: MEDTRONIC CONDUCTED AN INVESTIGATION BASED UPON ALL INFORMATION RECEIVED. THE DEVICE WAS AVAILABLE FOR EVALUATION. THE EVALUATION FOUND NO POTENTIALLY CONTRIBUTING FACTORS, AND THE SAMPLE MET ALL RELATED SPECIFICATIONS. IT WAS REPORTED THAT THE INSTRUMENT DID NOT FIRE AND LOCKED ON TISSUE. THE REPORTED ISSUES COULD NOT BE CONFIRMED. THE MOST LIKELY CAUSE COULD NOT BE IDENTIFIED BECAUSE NO RELATED PROBLEM WAS DETECTED WITH THE DEVICE. THE MANUFACTURING RECORDS FOR EACH DEVICE ARE THOROUGHLY REVIEWED PRIOR TO RELEASE TO ENSURE THAT IT MEETS ALL MEDTRONIC QUALITY SPECIFICATIONS. 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 ROBOTIC NEPHRECTOMY PROCEDURE, WHEN THE SURGEON ATTEMPTED TO CUT THE RENAL VEIN, THE SURGEON POSITIONED THE JAW FULLY FOR ARTICULATION AND PRESSED THE GREEN BUTTON TO FIRE THE STAPLER. HOWEVER, NOTHING HAPPENED WHEN THE SURGEON TRIED TO CONTROL THE STAPLER. THE SURGEON WAS UNABLE TO FIRE IT AND COULD NOT OPEN THE JAW FULLY IN THE ARTICULATION POSITION. THE SURGEON RETURNED THE JAW TO THE NEUTRAL POSITION, AND AT THAT MOMENT, THE RENAL VEIN TORE. TO CONTROL THE BLEEDING, THE SURGEON USED A HEM-O-LOK CLIP AND SUCCESSFULLY MANAGED IT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    883520 ENDO GIA STAPLE, IMPLANTABLE GDW COVIDIEN LP LLC NORTH HAVEN EGIA45AVM N9K0126KY 10884523003178

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention SEE H11.