BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDO GIA

    MDR report key: 16920932 · Received May 12, 2023

    Report

    Report Number
    3003139373-2023-00115
    Event Type
    Injury
    Date Received
    May 12, 2023
    Date of Event
    July 29, 2022
    Report Date
    May 12, 2023
    Manufacturer
    CELESTICA DE MONTERREY S.A. DE C.V.
    Product Code
    GDW
    UDI-DI
    10884523002867
    PMA / PMN Number
    K111825
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D10 CONCOMITANT PRODUCT: UNKNOWN EEA - UNKNOWN EEA, LOT# UNK UNEGIATRI - UNKNOWN EGIA TRI STAPLE, LOT# UNK UNKNOWN ENDO GI - UNKNOWN ENDO GIA INSTRUMENT, LOT# UNK UNKNOWN-VLOC - UNKNOWN VLOC PRODUCT, LOT# UNK UNKNOWN HERNIA - UNKNOWN HERNIA STAPLER, LOT# UNK TITLE: TRANSITION FROM A CIRCULAR TO A LINEAR STAPLING PROTOCOL IN LAPAROSCOPIC ROUX-EN-Y GASTRIC BYPASS SURGERY AND ITS IMPACT ON Q UALITY OF LIFE: A 5-YEAR OUTCOME STUDY SOURCE: LANGENBECK'S ARCHIVES OF SURGERY (2022) 407:3341¿3348 / HTTPS://DOI.ORG/10.1007/S00423-022-02635-0 / ACCEPTED: 29 JULY 2022. 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 LITERATURE SOURCE OF THE STUDY PERFORMED, WHICH AIMED TO REPORT THE OUTCOMES AFTER CIRCULAR STAPLING PROTOCOL VERSUS LINEAR STAPLING PROTOCOL IN PATIENTS WHO UNDERWENT ROUX-EN-Y GASTRIC BYPASS BETWEEN JUNE 2012 AND MARCH 2016. IN THE CIRCULAR STAPLER GROUP (CSP) THE ENTEROENTEROSTOMY (EE) WAS PERFORMED USING A BLUE FORTY FIVE MILLIMETER (45MM) RELOAD. A LINEAR STAPLER WAS ALSO USED TO CLOSE THE INSERTION SITE OF THE CIRCULAR STAPLER. THERE WERE 117 PATIENTS IN THE CIRCULAR STAPLER GROUP. EARLY COMPLICATIONS IN CSP INCLUDED INTRAABDOMINAL ABSCESS WERE OBSERVED IN THREE (3) PATIENTS. ANASTOMOTIC LEAKS AT EE WERE OBSERVED IN 5 PATIENTS. LATE COMPLICATIONS INCLUDE TWO PATIENTS THAT HAD BLEEDING. INTERNAL HERNIA AT EE WERE OBSERVED UNDER 5 PATIENTS BUT WAS NOT DEVICE RELATED. READMISSIONS AND REOPERATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1308861 ENDO GIA STAPLE, IMPLANTABLE GDW CELESTICA DE MONTERREY S.A. DE C.V. 030455 10884523002867

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention| H