BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDO GIA

    MDR report key: 16085889 · Received January 3, 2023

    Report

    Report Number
    1219930-2023-00001
    Event Type
    Malfunction
    Date Received
    January 3, 2023
    Date of Event
    October 18, 2022
    Report Date
    January 3, 2023
    Manufacturer
    COVIDIEN LP LLC NORTH HAVEN
    Product Code
    GDW
    UDI-DI
    10884523003178
    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

    CONCOMITANT MEDICAL PRODUCTS: EGIAUSHORT - EGIAUSHORT ENDOGIA ULTRA UNIV SHT STAP, LOT# P2G0013, EGIA45AVM - EGIA45AVM EGIA 45 ARTIC VASC MED SULU, LOT# N2E0345Y, EGIAUSHORT - EGIAUSHORT ENDOGIA ULTRA UNIV SHT STAP, LOT# P2G0013. EVALUATION SUMMARY: "MEDTRONIC CONDUCTED AN INVESTIGATION BASED UPON ALL INFORMATION RECEIVED. THE DEVICE WAS AVAILABLE FOR EVALUATION. A COMPREHENSIVE EXAMINATION COULD NOT BE PERFORMED, BECAUSE THE RETURNED SAMPLE WAS NOT RECEIVED IN A STATE THAT ALLOWED FULL FUNCTIONAL OR VISUAL ASSESSMENT. NO INFORMATION REGARDING THE SPECIFIC CUSTOMER ISSUE THAT OCCURRED WITH THE DEVICE WAS AVAILABLE. VISUAL INSPECTION NOTED THAT THE DEVICE WAS APPLIED ON OVER INDICATED TISSUE. FUNCTIONALLY, THE RELOAD WAS LOADED INTO A REPRESENTATIVE INSTRUMENT, WAS CYCLED WITHOUT HESITATION OR BINDING AND WAS APPLIED TO TEST MEDIA. THE TEST MEDIA WAS CLEANLY TRANSECTED. THE RELOAD INTERLOCK WAS TESTED AND FOUND TO FUNCTION PROPERLY. THIS ISSUE MAY OCCUR UNDER THE FOLLOWING CONDITIONS. APPLICATION OVER TISSUE THAT IS BEYOND THE RECOMMENDED THICKNESS RANGE. APPLICATION WITH AN OBSTACLE INCORPORATED IN THE JAWS. IN ANY OF THESE CIRCUMSTANCES, 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: 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 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 IS SUBMITTING THIS REPORT TO COMPLY WITH FDA REPORTING REGULATIONS UNDER 21 CFR PARTS 4 AND 803. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION AND HAS PROVIDED 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. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY ¿DEFECTS¿ OR HAS ¿MALFUNCTIONED¿. THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REGULATORY REPORTING. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE THEM BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 0

    ACCORDING TO THE REPORTER, DURING A VIDEO ASSISTED THORACOSCOPIC LOBECTOMY, WHILE AT THE EMPHYSEMA LUNG PARENCHYMA, THE FIRST STAPLE SEAM COULD BE PLACED, BUT THE OVERLOAD PROTECTION HAS STRUCK.  ANOTHER STAPLE SEAM COULD NO LONGER BE PLACED WITH THE DEVICE. THE SURGEON THEN INSERTED A NEW DEVICE, BUT IT HAS THE SAME ISSUE. BOTH DEVICE DID NOT FIRE. THE SURGEON PRESSED THE GREEN BUTTON BUT UNABLE TO SQUEEZED THE HANDLE. THEN A THIRD HANDLE WAS USED WHERE THE OVERLOAD PROTECTION RESPONDED. THE TWO RELOADS WERE ABLE TO BE TRIGGERED AFTER EXCHANGING THE HANDLE. NO PATIENT INJURY. PLI 20 AND PLI 40: MEDTRONIC'S INITIAL EVALUATION OF THE INCIDENT IS THAT AN UNREPORTED CONDITION OF DEFORMATION OF CLAMPING MECHANISM THAT HAS NO RELATIONSHIP TO THE REPORTED CONDITION. STAPLE PUSHERS WERE PARTIALLY FLUSH WITH THE CARTRIDGE. PLI 30: MEDTRONIC'S INITIAL EVALUATION OF THE INCIDENT IS THAT THE INSTRUMENT LOADED, CLAMPED, YET WOULD NOT CYCLE DUE TO THE SHEARED FIRING RACK TEETH DAMAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    146395 ENDO GIA STAPLE, IMPLANTABLE GDW COVIDIEN LP LLC NORTH HAVEN EGIA45AVM N2E0345Y 10884523003178

    Patients

    Seq Age Sex Outcome Treatment
    1 Female