BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOPATH*TROCAR

    MDR report key: 1862267 · Received October 8, 2010

    Report

    Report Number
    3005075853-2010-05782
    Event Type
    Injury
    Date Received
    October 8, 2010
    Date of Event
    September 14, 2010
    Report Date
    September 24, 2010
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GEA
    PMA / PMN Number
    K920110
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). TO DATE NO RESPONSE HAS BEEN PROVIDED. IF FURTHER DETAILS ARE RECEIVED AT A LATER DATE, A SUPPLEMENTAL MEDWATCH WILL BE SENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PLEURECTOMY PROCEDURE, WHILE TROCAR WAS IN PATIENT THE TROCAR BROKE. WHEN SURGEON REMOVED THE BROKEN TROCAR AND EXAMINED IT, A SMALL PIECE WAS UNABLE TO BE FOUND. THE SURGEON IS SUSPICIOUS THAT IT COULD BE LOST WITHIN THE PATIENT. THE SURGEON HAS REPORTED IT AS AN INCIDENT AND EXPLAINED TO THE PATIENT WHAT HAS OCCURRED. THE SURGEON HAS KEPT THE TROCAR. THE CONDITION OF THE PATIENT IMMEDIATELY FOLLOWING THE EVENT WAS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOPATH*TROCAR ENDOPATH*THORACIC TROCAR SLEEV GEA ETHICON ENDO-SURGERY, LLC. NA G4RU3D

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention