BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN ENDO GIA SULU

    MDR report key: 21061085 · Received January 2, 2025

    Report

    Report Number
    1219930-2025-00025
    Event Type
    Injury
    Date Received
    January 2, 2025
    Date of Event
    August 19, 2024
    Report Date
    January 2, 2025
    Manufacturer
    COVIDIEN LP LLC NORTH HAVEN
    Product Code
    GDW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D10 CONCOMITANT PRODUCTS: UNKNOWN EGIA SU - UNKNOWN ENDO GIA SULU, LOT# UNKNOWN LITERATURE EVENTS: AUTHOR: MICHELE MAZZOLA1 · ANTONIO BENEDETTI1· ALESSANDRO GIANI1· PIETRO CALCAGNO1 · ANDREA ZIRONDA1 · MICHELE PATERNO1 · ALESSANDRO GIACOMONI1 · PAOLO DE MARTINI1· GIOVANNI FERRARI1 TITLE: ABDOMINAL DRAINAGE AFTER MINIMALLY INVASIVE DISTAL PANCREATECTOMY: OUT OF SIGHT, OUT OF MIND?: MICHELE MAZZOLA; 2024; SURGICAL ENDOSCOPY SOURCE: SURGICAL ENDOSCOPY (2024) 38:6396¿6405 / HTTPS://DOI.ORG/10.1007/S00464-024-11217-8. 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 A PROSPECTIVE AND RETROSPECTIVE STUDY PERFORMED BETWEEN 2013 AND 2023, INVOLVING 116 PATIENTS WHO UNDERWENT MINIMALLY INVASIVE DISTAL PANCREATECTOMY (MIDP) WITH OR WITHOUT SPLENECTOMY BETWEEN 2012 AND 2023. PANCREATIC TRANSECTION WAS PERFORMED USING A 60MM STAPLER. SPLENIC VESSELS WERE SECTIONED USING EITHER AN UNKNOWN VASCULAR STAPLER OR COMPETITOR CLIPS. DEVICE RELATED COMPLICATIONS INCLUDED POSTOPERATIVE PANCREATIC FISTULA (POPF), POSTOPERATIVE BLEEDING, AND ABDOMINAL FLUID COLLECTION. THE POPFS REQUIRED REOPERATION, ENDOSCOPY, OR PERCUTANEOUS DRAINAGE. THE POSTOPERATIVE BLEEDING REQUIRED REOPERATION. READMISSIONS WERE ALSO REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1396186 UNKNOWN ENDO GIA SULU STAPLE, IMPLANTABLE GDW COVIDIEN LP LLC NORTH HAVEN UNKNOWN ENDO GIA SULU

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Female Hospitalization| R| O