BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SIGNIA

    MDR report key: 17079114 · Received June 7, 2023

    Report

    Report Number
    1219930-2023-02301
    Event Type
    Malfunction
    Date Received
    June 7, 2023
    Date of Event
    May 22, 2023
    Report Date
    June 7, 2023
    Manufacturer
    COVIDIEN LP LLC NORTH HAVEN
    Product Code
    GDW
    UDI-DI
    10884521543782
    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). 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 SIGPSHELL SIG POWER SIGPSHELL CONTROL SHELL 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, 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
    482015 SIGNIA STAPLE, IMPLANTABLE GDW COVIDIEN LP LLC NORTH HAVEN SIGPHANDLE 10884521543782

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Female SEE H10.