BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN ENDO GIA SULU

    MDR report key: 19571039 · Received June 19, 2024

    Report

    Report Number
    1219930-2024-02735
    Event Type
    Injury
    Date Received
    June 19, 2024
    Date of Event
    April 3, 2024
    Report Date
    June 19, 2024
    Manufacturer
    COVIDIEN LP LLC NORTH HAVEN
    Product Code
    GDW
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D10 CONCOMITANT PRODUCTS: UNKNOWN EEA, UNKNOWN EEA (SERIAL#:UNK) (LOT#:UNK) TITLE: COMPARATIVE ANALYSIS OF LINEAR- AND CIRCULAR-STAPLED GASTROJEJUNOSTOMIES IN ROUX-EN-Y GASTRIC BYPASS: A FOCUS ON POSTOPERATIVE MORBIDITY USING THE COMPREHENSIVE COMPLICATION INDEX SOURCE: LANGENBECK'S ARCHIVES OF SURGERY (2024) 409:120 HTTPS://DOI.ORG/10.1007/S00423-024-03303-1 MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE 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. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Description of Event or Problem · 0

    ACCORDING TO THE LITERATURE, A RETROSPECTIVE STUDY COMPARED THE OUTCOMES AFTER LINEAR-STAPLED AND THE CIRCULAR-STAPLED ANASTOMOSIS TECHNIQUE FOR GASTROJEJUNOSTOMY IN PATIENTS WHO UNDERWENT LAPAROSCOPIC ROUX-EN-Y GASTRIC BYPASS BETWEEN 2010 AND 2019. IN THE CIRCULAR STAPLER GROUP, AN CIRCULAR STAPLER 25MM WAS USED FOR THE ANASTOMOSIS. A GASTRIC TUBE WITH THE ANVIL CONNECTED WAS INTRODUCED ORALLY. IN THE LINEAR GROUP, A 30MM OR 45MM LINEAR STAPLER WAS USED FOR THE ANASTOMOSIS. THERE WERE 290 PATIENTS IN THE LINEAR STAPLED GROUP AND 298 PATIENTS IN THE CIRCULAR STAPLED GROUP. COMPLICATIONS INCLUDED ANASTOMOTIC LEAK, SURGICAL SITE INFECTION, POSTOPERATIVE BLEEDING, AND ANASTOMOTIC STENOSIS. COMPLICATIONS WERE DIAGNOSED ACCORDING TO THE CLINICAL PRESENTATION AND INCLUDED CT-SCANS, UPPER ENDOSCOPIES, DYNAMIC IMAGING (CONTRAST SWALLOW), AND/OR DIAGNOSTIC LAPAROSCOPY. THERE WAS A PATIENTS WITH PULMONARY SEPSIS, MYOCARDIAL INFRACTION, CEREBRAL ISCHEMIA AND CARDIAC EVENTS. OTHER COMPLICATIONS THAT WERE NOT RELATED TO THE DEVICE INCLUDED INTERNAL HERNIAS AND MARGINAL ULCERS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2194821 UNKNOWN ENDO GIA SULU STAPLE, IMPLANTABLE GDW COVIDIEN LP LLC NORTH HAVEN UNKNOWN ENDO GIA SULU

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other SEE H11