BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDO GIA

    MDR report key: 12003593 · Received June 15, 2021

    Report

    Report Number
    1219930-2021-02384
    Event Type
    Injury
    Date Received
    June 15, 2021
    Date of Event
    May 25, 2021
    Report Date
    October 11, 2021
    Manufacturer
    COVIDIEN LP LLC NORTH HAVEN
    Product Code
    GDW
    UDI-DI
    10884523003215
    PMA / PMN Number
    K111825
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: B5, G3, H3, H6 H3 EVALUATION SUMMARY: MEDTRONIC CONDUCTED AN INVESTIGATION BASED UPON ALL INFORMATION RECEIVED. TWO DEVICES WERE RETURNED FOR ANALYSIS. VISUAL INSPECTION NOTED THAT BOTH RELOADS WERE PARTIALLY FIRED, HAD DEFORMED CLAMPING MECHANISM, AND HAD STAPLE PUSHERS THAT WERE FLUSH WITH THE CARTRIDGES. FUNCTIONAL EVALUATION NOTED THAT THE RELOADS WERE ABLE TO BE LOADED, CYCLED, AND FIRED ON TEST MEDIA OF APPROPRIATE THICKNESS WITH NO ABNORMALITIES. THE MANUFACTURING RECORDS FOR EACH DEVICE ARE THOROUGHLY REVIEWED PRIOR TO RELEASE TO ENSURE THAT IT HAS MET ALL MEDTRONIC QUALITY SPECIFICATIONS. ALL REPORTED CONDITIONS WERE CONFIRMED. THE ANALYSIS NOTED EVIDENCE THAT THE DEVICE WAS NOT USED AS INTENDED. REPLICATION OF THE DEFORMED CLAMPING MECHANISM, PARTIAL FIRING, AND FLUSH STAPLE PUSHERS MAY OCCUR UNDER THE FOLLOWING CONDITIONS: FIRST, APPLICATION OVER TISSUE THAT IS BEYOND THE RECOMMENDED THICKNESS RANGE AND, SECOND, 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 INSTRUCTION PROVIDED TO THE USER INCLUDES, ¿FAILURE TO COMPLETELY FIRE THE RELOAD WILL RESULT IN AN INCOMPLETE CUT OR INCOMPLETE STAPLE FORMATION, WHICH MAY RESULT IN POOR HEMOSTASIS 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 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.

    Additional Manufacturer Narrative · 0

    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 LAPAROSCOPIC VIDEO-ASSISTED THORACOSCOPIC SURGERY, ON STAPLING AND CUTTING, THE STAPLER WAS ABLE TO FIRE, THE STAPLE LINE WAS INCOMPLETE DISTALLY. THE DEVICE INDICATED TISSUE WAS FINE TO STAPLE PRIOR TO FIRING, HALFWAY TROUGH, THE INSTRUMENT STOPPED FIRING AND WAS UNABLE TO COMPLETE THE FIRING CYCLE AND SHOWED A MESSAGE THAT THE TISSUE WAS TOO THICK. IN TOTAL 5 RELOADS WERE USED FROM TWO DIFFERENT LOTS ALL WITH THE SAME RESULTS. A MANUAL HANDLE AND NEW RELOAD WAS USED AND EVENTUALLY OVERSEWING WAS DONE TO FINISH THE CASE.

    Description of Event or Problem · 0

    ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC VIDEO-ASSISTED THORACOSCOPIC SURGERY, ON STAPLING AND CUTTING, THE STAPLER WAS ABLE TO FIRE, AND THE STAPLE LINE WAS INCOMPLETE DISTALLY. THE DEVICE INDICATED TISSUE WAS FINE TO STAPLE PRIOR TO FIRING, BUY HALFWAY THROUGH THE INSTRUMENT STOPPED FIRING AND WAS UNABLE TO COMPLETE THE FIRING CYCLE AND SHOWED A MESSAGE THAT THE TISSUE WAS TOO THICK. IN TOTAL OF FIVE RELOADS THAT WERE USED FROM TWO DIFFERENT LOTS, ALL HAD THE SAME RESULTS. A MANUAL HANDLE AND NEW RELOAD WERE USED AND EVENTUALLY OVERSEWING WAS DONE TO FINISH THE CASE.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC VIDEO-ASSISTED THORACOSCOPIC SURGERY, ON STAPLING AND CUTTING, THE STAPLER WAS ABLE TO FIRE, THE STAPLE LINE WAS INCOMPLETE DISTALLY. THE DEVICE INDICATED TISSUE WAS FINE TO STAPLE PRIOR TO FIRING, HALFWAY TROUGH, THE INSTRUMENT STOPPED FIRING AND WAS UNABLE TO COMPLETE THE FIRING CYCLE AND SHOWED A MESSAGE THAT THE TISSUE WAS TOO THICK. IN TOTAL 5 RELOADS WERE USED FROM TWO DIFFERENT LOTS ALL WITH THE SAME RESULTS. A MANUAL HANDLE AND NEW RELOAD WAS USED AND EVENTUALLY LOOPS WERE USED TO FINISH THE CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    898695 ENDO GIA STAPLE, IMPLANTABLE GDW COVIDIEN LP LLC NORTH HAVEN EGIA60AMT N1C0292Y 10884523003215

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention