BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOPATH XCEL

    MDR report key: 21631912 · Received March 18, 2025

    Report

    Report Number
    21631912
    Event Type
    Injury
    Date Received
    March 18, 2025
    Date of Event
    February 22, 2025
    Report Date
    March 11, 2025
    Manufacturer
    ETHICON ENDO-SURGERY, LLC
    Product Code
    GCJ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    UT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    MEDICAL DOCTOR PERFORMING THORACOSCOPIC LUNG DECORTICATION/VATS (VIDEO-ASSISTED THORACIC SURGERY) IN MAIN OR 1. WHEN REMOVING SIZE 12 TROCAR, TROCAR SLEEVE BROKE INTO PIECES. SOME OF THE PIECES WENT INSIDE THE PATIENT. ALL PIECES WERE RETRIEVED WITH THE EXCEPTION OF PIECES THAT WERE TOO SMALL TO SEE. MANUFACTURER RESPONSE FOR LAPAROSCOPE, GENERAL PLASTIC SURGERY, ENDOPATH XCEL (PER SITE REPORTER). [REDACTED] RECEIVED THIS PRODUCT FROM MEDLINE. WE HAVE EMAILED MEDLINE, AND THEY HAVE CONFIRMED THEY HAVE REACHED OUT TO MEDTRONIC ON [REDACTED]. WE HAVE NOT HEARD ANYTHING SINCE REPORTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    451836 ENDOPATH XCEL LAPAROSCOPE, GENERAL PLASTIC SURGERY GCJ ETHICON ENDO-SURGERY, LLC B12LT

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Male