BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN - MAXON

    MDR report key: 17694501 · Received September 6, 2023

    Report

    Report Number
    9612501-2023-01528
    Event Type
    Injury
    Date Received
    September 6, 2023
    Date of Event
    June 16, 2022
    Report Date
    September 6, 2023
    Manufacturer
    DAVIS & GECK CARIBE LTD
    Product Code
    GAM
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    D10 CONCOMITANT PRODUCT: EGIA60AMT EGIA 60 ARTIC MED THICK SULU (LOT#: UNKNOWN) HIROYA IIDA, HIROMITSU MAEHIRA, TAKERU MAEKAWA, HARUKI MORI, NOBUHITO NITTA, KATSUSHI TAKEBAYASHI, MASATSUGU KOJIMA, MIKA KURIHARA, SHIGEKI BAMBA, MASAYA SASAKI, MASAJI TANI. EFFECT OF THE GASTROJEJUNOSTOMY POSITION ON THE POSTOPERATIVE AMOUNT OF ORAL INTAKE IN PANCREATICODUODENECTOMY. EUROPEAN SURGICAL RESEARCH 2023;64, DOI: 10.1159/000525551. PAGES 211¿219. 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.

    Description of Event or Problem · 0

    ACCORDING TO THE LITERATURE, A RETROSPECTIVE STUDY INVESTIGATED THE EFFECT OF THE GASTROJEJUNOSTOMY POSITION ON THE POSTOPERATIVE ORAL INTAKE IN PATIENTS WHO UNDERWENT PANCREATICODUODENECTOMY BETWEEN JUNE 2013 AND DECEMBER 2019. THE GASTROJEJUNOSTOMY WAS PERFORMED VIA THE ANTECOLIC ROUTE USING STAPLED ANASTOMOSIS IN ALL CASES. FOR THE PANCREATICOJEJUNOSTOMY, AN INNER MUCOSAL ANASTOMOSIS WAS PERFORMED BETWEEN THE PANCREATIC DUCT AND JEJUNAL MUCOSA USING 8 INTERRUPTED 5-0 ABSORBABLE SUTURES. THE OUTER LAYER WAS PERFORMED WITH A COMPETITOR SUTURE. THERE WERE 119 PATIENTS IN THE STUDY AND COMPLICATIONS RELATED TO ABSORBABLE SUTURE INCLUDED: POSTOPERATIVE PANCREATIC FISTULA AND DEEP ORGAN SPACE INFECTION. PROLONGED HOSPITALIZATION WAS REPORTED. OTHER INTERVENTIONS WERE NOT SPECIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1455204 UNKNOWN - MAXON SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC AC GAM DAVIS & GECK CARIBE LTD UNKNOWN - MAXON

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention| H