BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BASX BLADELESS TROCAR

    MDR report key: 2083302 · Received May 10, 2011

    Report

    Report Number
    3005075853-2011-01901
    Event Type
    Malfunction
    Date Received
    May 10, 2011
    Date of Event
    April 21, 2011
    Report Date
    April 22, 2011
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GCJ
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE ANALYSIS RESULTS OF THE DEVICE (A) FOUND THAT IT WAS RECEIVED IN GOOD CONDITION. UPON TESTING, A 5 MM TEST DEVICE WAS INSERTED AND REMOVED THROUGH THE DEVICE WITHOUT ANY ANOMALIES NOTED. NO CONCLUSION COULD BE REACHED AS TO WHAT MAY HAVE CAUSED THE REPORTED INCIDENT. THE BATCH RECORD WAS REVIEWED AND NO ANOMALIES WERE NOTED DURING THE MANUFACTURING PROCESS. THE ANALYSIS RESULTS OF THE DEVICE (B) FOUND THAT IT WAS RECEIVED IN GOOD CONDITION. UPON TESTING, A 5 MM TEST DEVICE WAS INSERTED AND REMOVED THROUGH THE DEVICE WITHOUT ANY ANOMALIES NOTED. NO CONCLUSION COULD BE REACHED AS TO WHAT MAY HAVE CAUSED THE REPORTED INCIDENT. THE BATCH RECORD WAS REVIEWED AND NO ANOMALIES WERE NOTED DURING THE MANUFACTURING PROCESS. DEVICE B ADDITIONAL INFORMATION: BATCH # G9KY65 EXPIRATION DATE: 07/2015 MANUFACTURING DATE: 08/2010 (B)(4).

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE SEAL WAS BROKEN. THE SURGEON HAD DIFFICULTY IN TAKING THE HARMONIC SCALPEL OUT OF THE CANNULA AND "PULL THE SCALPEL". ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BASX BLADELESS TROCAR GCJ ETHICON ENDO-SURGERY, LLC. NA G4U157

    Patients

    Seq Age Sex Outcome Treatment
    1 HARMONIC SCALPEL