BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOPATH** DEXTRUS*

    MDR report key: 1894149 · Received November 9, 2010

    Report

    Report Number
    3005075853-2010-06391
    Event Type
    Malfunction
    Date Received
    November 9, 2010
    Date of Event
    October 17, 2010
    Report Date
    October 20, 2010
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GCJ
    PMA / PMN Number
    K070198
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE ANALYSIS RESULTS OF THE FOUND THAT IT WAS RECEIVED WITH THE IRIS TORN. THE TEAR INITIATED NEAR TO THE UPPER INNER RING AND SPIRALED TO THE LOWER RING. NO CONCLUSION COULD BE REACHED AS TO WHAT MAY HAVE CAUSED THE FOUND CONDITION OF THE IRIS. IT SHOULD BE NOTED THAT THE ACCUMULATION OF BODY FLUIDS IS A ROUTINE OCCURRENCE DURING SURGICAL PROCEDURES AND DOES NOT NECESSARILY INDICATE A MANUFACTURING DEFECT IN THE DEVICE. THE BATCH RECORD WAS REVIEWED AND NO ANOMALIES WERE NOTED DURING THE MANUFACTURING PROCESS.

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.

    Description of Event or Problem · 1

    PT WAS REVISED TO ADDRESS THREAT OF INFECTION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BEFORE A HEPATECTOMY PROCEDURE, AS THE NURSE OPENED THE STERILE PACKAGE, IT WAS NOTICED THAT THE SEAL CAP WAS TORN. UNKNOWN HOW CASE WAS COMPLETED. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOPATH** DEXTRUS* LAPAROSCOPE, GENERAL AND PLASTIC SURGERY GCJ ETHICON ENDO-SURGERY, LLC. GATT29

    Patients

    Seq Age Sex Outcome Treatment
    1