BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN EEA

    MDR report key: 19521136 · Received June 12, 2024

    Report

    Report Number
    2647580-2024-02580
    Event Type
    Injury
    Date Received
    June 12, 2024
    Date of Event
    April 11, 2024
    Report Date
    June 12, 2024
    Manufacturer
    US SURGICAL PUERTO RICO
    Product Code
    GDW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D10 CONCOMITANT PRODUCT: UNKNOWN EEA (LOT #: UNKNOWN). UNKNOWN EGIA SU, UNKNOWN ENDO GIA SULU (LOT #: UNKNOWN). UNKNOWN EEA (LOT #: UNKNOWN). LUCAS SOARES GERBASI, FRANCISCO TUSTUMI, VICTOR EDMOND SEID, SERGIO EDUARDO ALONSO ARAUJO. DOES TRI-STAPLE¿ TECHNOLOGY REDUCE THE RISK OF ANASTOMOTIC LEAKAGE IN COLORECTAL SURGERY? A PROPENSITY SCORE MATCHING ANALYSIS. JOURNAL OF SURGICAL ONCOLOGY 2024. DOI: 10.1002/JSO.27650. PAGES 1¿8. 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 SOURCE OF STUDY PERFORMED BETWEEN 2016 AND 2022, A RETROSPECTIVE STUDY EVALUATED CONSECUTIVE PATIENTS DIAGNOSED WITH COLORECTAL ADENOCARCINOMA WHO UNDERWENT ELECTIVE RECTOSIGMOIDECTOMY WITH PRIMARY ANASTOMOSIS. PATIENTS INCLUDED IN THE STUDY UNDERWENT COLORECTAL ANASTOMOSIS USING EITHER THE DIRECTIONAL STAPLING TECHNOLOGY CIRCULAR STAPLER OR THE TRISTAPLE CIRCULAR STAPLER. A TOTAL OF 336 PATIENTS WERE INCLUDED IN THE STUDY, WITH 228 PATIENTS IN THE DIRECTIONAL STAPLING TECHNOLOGY CIRCULAR STAPLE GROUP AND 108 PATIENTS IN THE TRISTAPLE CIRCULAR STAPLER GROUP. IN THE TRISTAPLE CIRCULAR STAPLER GROUP, ANASTOMOTIC LEAK, UNSPECIFIED SERIOUS COMPLICATIONS, REOPERATIONS AND READMISSIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    367910 UNKNOWN EEA STAPLE, IMPLANTABLE GDW US SURGICAL PUERTO RICO UNKNOWN EEA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other| H| R