BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SIGNIA

    MDR report key: 17087729 · Received June 8, 2023

    Report

    Report Number
    1219930-2023-02327
    Event Type
    Malfunction
    Date Received
    June 8, 2023
    Date of Event
    May 22, 2023
    Report Date
    July 26, 2023
    Manufacturer
    COVIDIEN LP LLC NORTH HAVEN
    Product Code
    GDW
    UDI-DI
    10884521543812
    PMA / PMN Number
    K160176
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D10 CONCOMITANT PRODUCT/S: SIGADAPTXL SIG POWER SIGADAPTXL LINEAR XL ADAPTER SERIAL #:(B)(6) EGIA60AMT EGIA60AMT EGIA 60 ARTIC MED THICK SULU LOT #: P2K0040 EGIA60AMT EGIA60AMT EGIA 60 ARTIC MED THICK SULU LOT #: P2K0040 SIGPHANDLE SIG POWER SIGPHANDLE HANDLE SERIAL #: (B)(6) SIGPSHELL SIG POWER SIGPSHELL CONTROL SHELL LOT #: UNKNOWN H3 EVALUATION SUMMARY: MEDTRONIC CONDUCTED AN INVESTIGATION BASED UPON ALL INFORMATION RECEIVED. THE DEVICE WAS NOT RETURNED, BUT A PHOTO WAS AVAILABLE FOR EVALUATION. VISUAL INSPECTION NOTED BOTH ADAPTER FIRING RODS WERE EXTENDED SUBSTANTIALLY BEYOND HOME POSITION. IT WAS REPORTED THAT THE DEVICE ARTICULATED ON ITS OWN, AND THE DEVICE BROKE. THE REPORTED ISSUES COULD NOT BE CONFIRMED. THE MOST LIKELY CAUSE COULD NOT BE ESTABLISHED FROM THE INFORMATION AVAILABLE. THE EVALUATION DETECTED AN UNREPORTED CONDITION: AFTER DISASSEMBLING THE DEVICE, THE J-HOOK WAS EVALUATED. THERE WERE DEFORMATIONS PRESENT ON THE J-HOOK WHICH ARE INDICATIVE OF THE USER TRYING TO REMOVE THE RELOAD BEFORE THE FIRING ROD HAS RETURNED TO THE PROPER HOME POSITION. 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. 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 AND A PHOTO WERE AVAILABLE FOR EVALUATION. VISUAL INSPECTION NOTED BOTH ADAPTER FIRING RODS WERE EXTENDED SUBSTANTIALLY BEYOND HOME POSITION. FUNCTIONALLY, THE BLUE UNLOAD SWITCH COULD ONLY BE DEPRESSED PARTIALLY. THE ADAPTER WAS CONNECTED TO THE GEN2 ADAPTER BLACK BOX RUNNING GEN2 ACC SOFTWARE, THEN HAD 39 OF 50 PROCEDURES REMAINING. THE MAIN SCREEN INDICATED THE STRAIN GAUGE WAS FUNCTIONAL AND IN THE APPROPRIATE RANGE. NO ERRORS WERE FOUND RECORDED IN THE ADAPTER DATA. THE ADAPTER WAS CONNECTED TO A RPA HANDLE RUNNING V29.3 SOFTWARE AND CALIBRATED SUCCESSFULLY. A RPA LOADING UNIT COULD NOT BE LOADED INTO THE DISTAL END OF THE ADAPTER. THE ADAPTER WAS DISASSEMBLED AND TWO SECTIONS OF RELOAD ADAPTER LUG WERE FOUND IN THE DISTAL END OF THE ADAPTER. THE SECTIONS OF RELOAD LUG WERE REMOVED AND THE ADAPTER WAS REASSEMBLED. ALSO, A REPRESENTATIVE RELOAD WAS ATTACHED TO THE ADAPTER AND WAS ABLE TO BE LOADED AND UNLOADED WITHOUT DIFFICULTY. THE UNIT WAS ABLE TO BE ROTATED AND ARTICULATED IN ALL DIRECTIONS WITHOUT HANG-UPS OR SLUGGISHNESS, AND WAS ABLE TO BE FIRED WITHOUT ANY ISSUES. AFTER FIRING, THE UNIT WAS RECONNECTED TO THE GEN2 ACC SOFTWARE AND NO NEW ERRORS APPEARED. IT WAS REPORTED THAT THE DEVICE ARTICULATED ON ITS OWN AND BROKE. THE REPORTED ISSUE COULD NOT BE CONFIRMED. THE MOST LIKELY CAUSE COULD NOT BE ESTABLISHED FROM THE INFORMATION AVAILABLE. THE EVALUATION DETECTED AN UNREPORTED CONDITION: AFTER DISASSEMBLING THE DEVICE, THE J-HOOK WAS EVALUATED. THERE WERE DEFORMATIONS PRESENT ON THE J-HOOK WHICH ARE INDICATIVE OF THE USER TRYING TO REMOVE THE RELOAD BEFORE THE FIRING ROD HAS RETURNED TO THE PROPER HOME POSITION. THE PRODUCT ANALYSIS NOTED EVIDENCE THAT THE DEVICE WAS NOT USED AS INTENDED. 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: IF A STAPLING RELOAD IS DIFFICULT TO UNLOAD: 1. CENTER THE RELOAD AND FULLY OPEN THE JAWS BY MANUALLY CONTROLLING THE TOGGLE OR PRESS AND HOLD THE UP CONTROL BUTTON FOR TWO SECONDS. THE ARTICULATION WILL CENTER AND THE JAWS OF THE RELOAD WILL FULLY OPEN. 2. REATTEMPT TO UNLOAD THE STAPLING RELOAD BY PRESSING THE RELOAD UNLOAD BUTTON BACK TOWARD THE POWER HANDLE, TWIST THE RELOAD COUNTERCLOCKWISE 45 DEGREES AND REMOVE THE RELOAD FROM THE SHAFT OF THE ADAPTER. 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 AN EXPLORATORY LAPAROTOMY, WHEN THE DEVICE WAS BEING APPLIED IN THE APPENDIX, THE RELOAD WAS LOADED WITH NO ISSUES AND THE DEVICE WAS CYCLED. HOWEVER, WHEN THE SURGEON OPENED THE JAWS, THE STAPLER STARTED ARTICULATING ON ITS OWN AND FIRED OUTSIDE OF THE PATIENT ON ITS OWN, WITH THE JAWS OPEN FOR THE FIRST ADAPTER. THERE WAS ALSO AN UNEXPECTED ARTICULATION/ROTATION FOR THE SECOND ADAPTER. THERE WERE TWO RELOADS USED. IT WAS NOTED THAT THE TWO ADAPTERS WERE BROKEN. THE RELOAD AND ADAPTERS WERE RECONNECTED BUT THE ISSUE WAS NOT RESOLVED. ANOTHER STAPLER FROM ANOTHER MANUFACTURER WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1274131 SIGNIA STAPLE, IMPLANTABLE GDW COVIDIEN LP LLC NORTH HAVEN SIGADAPTXL 10884521543812

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Female