BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN ENDO GIA SULU

    MDR report key: 17952696 · Received October 17, 2023

    Report

    Report Number
    1219930-2023-04413
    Event Type
    Injury
    Date Received
    October 17, 2023
    Date of Event
    March 1, 2018
    Report Date
    October 17, 2023
    Manufacturer
    COVIDIEN LP LLC NORTH HAVEN
    Product Code
    GDW
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D10: CONCOMITANT PRODUCT: UNKNOWN LIGASUR - UNKNOWN LIGASURE INSTRUMENT, LOT# UNKNOWN LITERATURE EVENTS: MARTIN GAILLARD1,2 & HADRIEN TRANCHART1,2 & SOPHIE MAITRE2,3 & GABRIEL PERLEMUTER2,4 & PANAGIOTIS LAINAS1,2 & IBRAHIM DAGHER1, PREOPERATIVE DETECTION OF SARCOPENIC OBESITY HELPS TO PREDICT THE OCCURRENCE OF GASTRIC LEAK AFTER SLEEVE GASTRECTOMY; DR. MARTIN GAILLARD; OBESITY SURGERY (2018). 28:2379¿2385 / HTTPS://DOI.ORG/10.1007/S11695-018-3169-0. PUBLISHED ONLINE: 2 MARCH 2018. 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 AUGUST 2013 AND JUNE 2014, A RETROSPECTIVE STUDY EVALUATED THE EXISTENCE OF A POTENTIAL LINK BETWEEN SARCOPENIC OBESITY AND STAPLE-LINE LEAK RISK IN PATIENTS WHO UNDERWENT SLEEVE GASTRECTOMY. THE 60 MILLIMETER PURPLE RELOAD OR A COMPETITOR DEVICE WAS USED FOR THE TRANSECTION OF THE STOMACH. REINFORCEMENT OF THE STAPLE LINE WAS NOT PERFORMED ROUTINELY. A TOTAL OF 205 PATIENTS WERE INVOLVED IN THE ANALYSIS. POST OPERATIVE COMPLICATIONS INCLUDED GASTRIC LEAK, ABSCESS, HEMORRHAGE, HEMATOMA. NINE PATIENTS (4.4%) PRESENTED A GASTRIC LEAK. IN FOUR OUT OF NINE CASES, A RELAPAROSCOPY WAS REQUIRED TO EVACUATE AND DRAIN AN ABSCESS WITH SUBSEQUENT ENDOSCOPIC DRAINAGE. EXCLUSIVE ENDOSCOPIC MANAGEMENT WAS SUFFICIENT IN FIVE CASES. EIGHT PATIENTS (3.9%) PRESENTED INTRA-ABDOMINAL HEMORRHAGE/HEMATOMA POSTOPERATIVELY AND NECESSITATED A RELAPAROSCOPY TO TREAT BLEEDING OR TO EVACUATE A HEMATOMA. HOSPITAL STAY WAS EXTENDED AS A RESULT. THE STUDY SUGGESTS THAT SARCOPENIA IS ASSOCIATED WITH INCREASED RISK OF GASTRIC LEAK AFTER SLEEVE GASTRECTOMY POSSIBLY RELATED TO TISSUE THICKNESS AND MUSCLE TO FAT RATIO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2077725 UNKNOWN ENDO GIA SULU STAPLE, IMPLANTABLE GDW COVIDIEN LP LLC NORTH HAVEN UNKNOWN ENDO GIA SULU

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Male Required Intervention| H SEE H10