BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SIGNIA

    MDR report key: 15869275 · Received November 28, 2022

    Report

    Report Number
    1219930-2022-04657
    Event Type
    Malfunction
    Date Received
    November 28, 2022
    Date of Event
    November 8, 2022
    Report Date
    November 28, 2022
    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
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    CONCOMITANT MEDICAL PRODUCTS: SIG POWER SIGADAPTSTND LINEAR ADAPTER (SN:(B)(4)); EGIA60AMT EGIA 60 ARTIC MED THICK SULU (LOT#P2F0017); SIG POWER SIGPSHELL CONTROL SHELL (LOT#N2H0505Y); EGIA60AMT EGIA 60 ARTIC MED THICK SULU (LOT#P2F0017). 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 ASSISTED DISTAL GASTRECTOMY PROCEDURE, THE CARTRIDGE WAS CONNECTED AT THE TIME OF THE 4TH REMAINING GASTRODUODENAL ANASTOMOSIS. THERE WAS A CATCH WHEN THE PORT WAS INSERTED, WHEN IT WAS CHECKED, THE JAW DID NOT CLOSE NORMALLY. AFTERWARDS, IT WAS REPLACED WITH A NEW CARTRIDGE, BUT IN THE CARTRIDGE ALSO THE JAW DID NOT CLOSE COMPLETELY. THE ADAPTER HAS AN ERROR DISPLAY, POST-OPERATIVELY. A COMPETITOR DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1741950 SIGNIA STAPLE, IMPLANTABLE GDW COVIDIEN LP LLC NORTH HAVEN SIGPHANDLE 10884521543782

    Patients

    Seq Age Sex Outcome Treatment
    1 Male