BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOPATH* TROCAR

    MDR report key: 2140917 · Received June 27, 2011

    Report

    Report Number
    3005075853-2011-02600
    Event Type
    Malfunction
    Date Received
    June 27, 2011
    Date of Event
    May 10, 2011
    Report Date
    May 10, 2011
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GEA
    PMA / PMN Number
    K920110
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE ANALYSIS RESULTS FOUND THAT THE TT012 INSTRUMENTS (A AND B) WERE RECEIVED WITH THE SLEEVE CRACKED. AS EACH DEVICE IS VISUALLY INSPECTED AND FUNCTIONALLY TESTED DURING THE MANUFACTURING PROCESS, NO CONCLUSION COULD BE REACHED AS TO HOW THE DAMAGE TO THE DEVICE OCCURRED. THE BATCH RECORD WAS REVIEWED AND NO ANOMALIES WERE NOTED DURING THE MANUFACTURING PROCESS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE DEVICES WERE BROKEN JUST AFTER THE NURSE OPENED THE PACKAGE. IT IS UNKNOWN HOW THE PROCEDURE WAS COMPLETED. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOPATH* TROCAR GEA ETHICON ENDO-SURGERY, LLC. NA G4TG42

    Patients

    Seq Age Sex Outcome Treatment
    1