BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDO GIA

    MDR report key: 18373348 · Received December 21, 2023

    Report

    Report Number
    1219930-2023-05301
    Event Type
    Malfunction
    Date Received
    December 21, 2023
    Date of Event
    November 28, 2023
    Report Date
    February 26, 2024
    Manufacturer
    COVIDIEN LP LLC NORTH HAVEN
    Product Code
    GDW
    UDI-DI
    10884523003215
    PMA / PMN Number
    K111825
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D10 CONCOMITANT PRODUCT: EGIAUXL, EGIAUXL ENDOGIA ULTRA UNIV XL STAPLER (LOT#P2J0018); EGIA60AMT, EGIA60AMT EGIA 60 ARTIC MED THICK SULU (LOT#N2H0512Y). 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

    EVALUATION SUMMARY: MEDTRONIC CONDUCTED AN INVESTIGATION BASED UPON ALL INFORMATION RECEIVED. THE DEVICE WAS AVAILABLE FOR EVALUATION. VISUAL INSPECTION NOTED THAT THE RELOAD WAS PARTIALLY FIRED WITH THE INTERLOCK ENGAGED, THE JAWS WERE OPEN AND STAPLE PUSHERS WERE VISIBLE AT THE CUT LINE. FUNCTIONALLY, THE RELOAD WAS LOADED INTO A REPRESENTATIVE INSTRUMENT. THE INTERLOCK WAS OVERRIDDEN AND THE RELOAD WAS APPLIED TO TEST MEDIA. ALL REMAINING STAPLES WERE PLACED, AND TEST MEDIA WAS CLEANLY TRANSECTED. THE RELOAD INTERLOCK WAS TESTED AND FOUND TO FUNCTION PROPERLY. IT WAS REPORTED THAT THE DEVICE PARTIALLY FIRED. THE REPORTED ISSUE WAS CONFIRMED. THE PRODUCT ANALYSIS NOTED EVIDENCE THAT THE DEVICE WAS NOT USED AS INTENDED. THE ISSUE CAN OCCUR IF THE FIRING HANDLE HAS NOT BEEN COMPLETELY CYCLED. IF THE INSTRUMENT RETURN KNOBS WERE RETRACTED AT ANY POINT ONCE THE FIRING CYCLE HAS BEGUN, THE RELOAD WILL ENGAGE INTO SAFETY INTERLOCK AND PREVENT FURTHER ATTEMPTS TO FIRE BY CEASING THE PLACEMENT OF STAPLES AND TISSUE TRANSECTION AND PREVENT PATIENT HARM. IT WAS ALSO REPORTED THAT THE STAPLE LINE WAS INCOMPLETE. THE REPORTED ISSUE COULD NOT BE CONFIRMED. THE MOST LIKELY CAUSE COULD NOT BE ESTABLISHED FROM THE INFORMATION AVAILABLE. 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 OR INCOMPLETE STAPLE FORMATION, WHICH MAY RESULT IN POOR HEMOSTASIS OR LEAKAGE. 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, IN A LAPAROSCOPIC GASTRIC SLEEVE, DURING THE SECOND FIRING WITH A PURPLE RELOAD, THE SURGEON COULD NOT COMPLETELY SQUEEZE THE HANDLE. THE SURGEON WAS ABLE TO SQUEEZE THE HANDLE HARDLY WITH SOME CRACKING, PARTIALLY FIRING STAPLES, AND SUDDENLY STOPPED WITH INCOMPLETE FIRING OF THE RELOAD. THE PROXIMAL PART OF THE STAPLE LINE WAS ALSO INCOMPLETE. ANOTHER HANDLE AND BLACK RELOAD WAS USED. IN THE THIRD FIRING, THE SAME HANDLE AND ANOTHER PURPLE RELOAD WAS USED AND THE SAME ISSUE OCCURRED. ANOTHER PURPLE RELOAD WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

    Description of Event or Problem · 0

    ACCORDING TO THE REPORTER, IN A LAPAROSCOPIC GASTRIC SLEEVE, DURING THE SECOND FIRING WITH A PURPLE RELOAD, THE SURGEON COULD NOT COMPLETELY SQUEEZE THE HANDLE. THE SURGEON WAS ABLE TO SQUEEZE THE HANDLE HARDLY WITH SOME CRACKING, PARTIALLY FIRING STAPLES, AND SUDDENLY STOPPED WITH INCOMPLETE FIRING OF THE RELOAD. THE PROXIMAL PART OF THE STAPLE LINE WAS ALSO INCOMPLETE. ANOTHER HANDLE AND BLACK RELOAD WAS USED. IN THE THIRD FIRING, THE SAME HANDLE AND ANOTHER PURPLE RELOAD WAS USED AND THE SAME ISSUE OCCURRED. ANOTHER PURPLE RELOAD WAS USED TO COMPLETE THE CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2152158 ENDO GIA STAPLE, IMPLANTABLE GDW COVIDIEN LP LLC NORTH HAVEN EGIA60AMT N2H0512Y 10884523003215

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown