BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDO GIA

    MDR report key: 17592466 · Received August 21, 2023

    Report

    Report Number
    1219930-2023-03539
    Event Type
    Malfunction
    Date Received
    August 21, 2023
    Date of Event
    June 16, 2023
    Report Date
    November 8, 2023
    Manufacturer
    COVIDIEN LP LLC NORTH HAVEN
    Product Code
    GDW
    UDI-DI
    10884521820555
    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 PRODUCTS: EGIAUSTND, EGIAUSTND ENDOGIA ULTRA UNIV STD STAP, (LOT #P3B0402) 030403, 030403 GIA UNIVERSAL FOR OPEN SURGERY, (LOT #P3A0105) 030449, 030449 ENDO GIAII UNI INS, (LOT #UNKNOWN) H3 EVALUATION SUMMARY: MEDTRONIC CONDUCTED AN INVESTIGATION BASED UPON ALL INFORMATION RECEIVED. THE DEVICE WAS AVAILABLE FOR EVALUATION. VISUAL INSPECTION NOTED THE RELOAD WAS PARTIALLY FIRED AND THE CLAMPING MECHANISM WAS DEFORMED. IT WAS REPORTED THAT THE STAPLES DID NOT FORM AS EXPECTED AND THE INSTRUMENT WAS DIFFICULT TO FIRE BUT COMPLETED THE FIRING SEQUENCE. THE REPORTED ISSUES WERE CONFIRMED. THE PRODUCT ANALYSIS NOTED EVIDENCE THAT THE DEVICE WAS NOT USED AS INTENDED. 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 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 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.

    Additional Manufacturer Narrative · 0

    D10 CONCOMITANT PRODUCT: UNKNOWN EGIA SU, UNKNOWN ENDO GIA SULU (LOT#: UNKNOWN). 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 COMPLETE RECTAL EXTIRPATION, THE DEVICE WAS ABLE TO FIRE BUT WAS STIFF. THERE WERE ALSO POOR STAPLE FORMATION. ANOTHER HANDLE AND RELOAD WERE USED TO COMPLETE THE CASE.

    Description of Event or Problem · 0

    ACCORDING TO THE REPORTER, IN A COMPLETE RECTAL EXTIRPATION, WHILE IN THE DEEP RECTUM, THERE WAS POOR STAPLE FORMATION AT FIRST THEN THE DEVICES STOPPED WORKING. THREE HANDLES HAD UNUSUAL DIFFICULTY OR STIFFNESS WHEN SQUEEZING. THERE WERE ALSO LOUD CRACKING NOISES. ANOTHER HANDLE AND RELOAD WERE USED TO COMPLETE THE CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2330053 ENDO GIA STAPLE, IMPLANTABLE GDW COVIDIEN LP LLC NORTH HAVEN EGIA45AMT 10884521820555

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Male SEE H10| SEE NOTE ON H10