BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GIA

    MDR report key: 17134471 · Received June 15, 2023

    Report

    Report Number
    2647580-2023-02580
    Event Type
    Injury
    Date Received
    June 15, 2023
    Date of Event
    May 28, 2023
    Report Date
    June 15, 2023
    Manufacturer
    US SURGICAL PUERTO RICO
    Product Code
    GDW
    UDI-DI
    10884523007268
    PMA / PMN Number
    K111825
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D10 CONCOMITANT PRODUCT: GIA8038S, GIA8038S GIA 80-3.8SGL USE RELOAD STAP, (LOT #P2E0036). 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. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 0

    ACCORDING TO THE REPORTER, POST OPERATIVELY, ON A HEMI COLECTOMY, ON ANASTOMOSES ONCE THE SECTION WAS REMOVE, THE STAPLE LINE LOOKED FINE, HOWEVER THE PATIENT SUFFERED LEAKAGE FROM THE STAPLE LINE OF THE TWO DEVICES. THERE WAS BLOOD LOSS OF 500CC OR MORE DUE TO THE PRODUCT PROBLEM. IT WAS NOTED THE PATIENT WAS RETURNED TO THE THEATRE FOR OVER SEWING AND ADDITIONAL SURGERY. COMPUTERIZED TOMOGRAPHY ANGIOGRAM WAS DONE TO IDENTIFY THE POST-OPERATIVE LEAK OR BLEED AFTER 3 DAYS. THE PATIENT WAS TREATED AS ACUTE. THE PATIENT HAD PERI ARREST AND SHOCK AND WAS ADMITTED IN THE INTENSIVE CARE UNIT AND WAS HOSPITALIZED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1230907 GIA STAPLE, IMPLANTABLE GDW US SURGICAL PUERTO RICO GIA8038S P2J0561 10884523007268

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Hospitalization| R| O