BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN ENDO GIA SULU

    MDR report key: 14666015 · Received June 11, 2022

    Report

    Report Number
    1219930-2022-02187
    Event Type
    Injury
    Date Received
    June 11, 2022
    Date of Event
    August 26, 2021
    Report Date
    June 11, 2022
    Manufacturer
    COVIDIEN LP LLC NORTH HAVEN
    Product Code
    GDW
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    LITERATURE: TITLE: POSTOPERATIVE MORBIDITY AND QUALITY OF LIFE BETWEEN TOTALLY LAPAROSCOPIC TOTAL GASTRECTOMY AND LAPAROSCOPY-ASSISTED TOTAL GAS TRECTOMY: A PROPENSITY-SCORE MATCHED ANALYSIS SOURCE: PARK ET AL. BMC CANCER (2021) 21:1016 PARK ET AL. BMC CANCER (2021) 21:1016. 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 LITERATURE SOURCE OF STUDY PERFORMED BETWEEN 2012 AND 2018, TO EVALUATE OUTCOMES OF TOTALLY LAPAROSCOPIC TOTAL GASTRECTOMY (TLTG) COMPARED WITH LAPAROSCOPY-ASSISTED TOTAL GASTRECTOMY (LATG) IN PATIENTS WITH GASTRIC CANCER, IN ALL PATIENTS, A MANUAL LINEAR STAPLER WAS USED TO TRANSECT THE ESOPHAGUS, PERFORM THE SIDE-TO SIDE JEJUNO-JEJUNOSTOMY AND TO CLOSE THE JEJUNAL STUMP. A CIRCULAR 25MM MANUAL STAPLER WAS USED FOR THE ESOPHAGOJEJUNOSTOMY. THERE WERE 223 PATIENTS IN THE TLTG 223 AND 114 PATIENTS IN THE LATG GROUP. POSTOPERATIVE COMPLICATIONS INCLUDED: BLEEDING, ANASTOMOSIS LEAKAGE, FLUID COLLECTION, AND ESOPHAGOJEJUNOSTOMY STENOSIS. BLOOD TRANSFUSIONS WERE ALSO REQUIRED. ARTICLE: YUN-SUHK SUH, 2021, PARK ET AL. BMC CANCER (2021) 21:1016, HTTPS://DOI.ORG/10.1186/S12885-021-08744-1 PLI20. ACCORDING TO THE LITERATURE SOURCE OF STUDY PERFORMED BETWEEN 2012 AND 2018, TO EVALUATE OUTCOMES OF TOTALLY LAPAROSCOPIC TOTAL GASTRECTOMY (TLTG) COMPARED WITH LAPAROSCOPY-ASSISTED TOTAL GASTRECTOMY (LATG) IN PATIENTS WITH GASTRIC CANCER, IN ALL PATIENTS, A MANUAL LINEAR STAPLER WAS USED TO TRANSECT THE ESOPHAGUS, PERFORM THE SIDE-TO SIDE JEJUNO-JEJUNOSTOMY AND TO CLOSE THE JEJUNAL STUMP. A CIRCULAR 25MM MANUAL STAPLER WAS USED FOR THE ESOPHAGOJEJUNOSTOMY. THERE WERE 223 PATIENTS IN THE TLTG 223 AND 114 PATIENTS IN THE LATG GROUP. POSTOPERATIVE COMPLICATIONS INCLUDED: BLEEDING, ANASTOMOSIS LEAKAGE, FLUID COLLECTION, AND ESOPHAGOJEJUNOSTOMY STENOSIS. BLOOD TRANSFUSIONS WERE ALSO REQUIRED. ARTICLE: YUN-SUHK SUH, 2021, PARK ET AL. BMC CANCER (2021) 21:1016, HTTPS://DOI.ORG/10.1186/S12885-021-08744-1 PLI30. ACCORDING TO THE LITERATURE SOURCE OF STUDY PERFORMED BETWEEN 2012 AND 2018, TO EVALUATE OUTCOMES OF TOTALLY LAPAROSCOPIC TOTAL GASTRECTOMY (TLTG) COMPARED WITH LAPAROSCOPY-ASSISTED TOTAL GASTRECTOMY (LATG) IN PATIENTS WITH GASTRIC CANCER, IN ALL PATIENTS, A MANUAL LINEAR STAPLER WAS USED TO TRANSECT THE ESOPHAGUS, PERFORM THE SIDE-TO SIDE JEJUNO-JEJUNOSTOMY AND TO CLOSE THE JEJUNAL STUMP. A CIRCULAR 25MM MANUAL STAPLER WAS USED FOR THE ESOPHAGOJEJUNOSTOMY. THERE WERE 223 PATIENTS IN THE TLTG 223 AND 114 PATIENTS IN THE LATG GROUP. POSTOPERATIVE COMPLICATIONS INCLUDED: BLEEDING, ANASTOMOSIS LEAKAGE, FLUID COLLECTION, AND ESOPHAGOJEJUNOSTOMY STENOSIS. BLOOD TRANSFUSIONS WERE ALSO REQUIRED. ARTICLE: YUN-SUHK SUH, 2021, PARK ET AL. BMC CANCER (2021) 21:1016, HTTPS://DOI.ORG/10.1186/S12885-021-08744-1.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    49501 UNKNOWN ENDO GIA SULU STAPLE, IMPLANTABLE GDW COVIDIEN LP LLC NORTH HAVEN UNKNOWN ENDO GIA SULU

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention