BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BASX BLADELESS TROCAR

    MDR report key: 2518201 · Received April 5, 2012

    Report

    Report Number
    3005075853-2012-01581
    Event Type
    Malfunction
    Date Received
    April 5, 2012
    Date of Event
    March 5, 2012
    Report Date
    March 15, 2012
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    KDC
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION IS UNAVAILABLE; DEVICE WAS NOT RETURNED FOR EVALUATION. ADDITIONAL INFORMATION: MULTIPLE REQUEST FOR RETURN OF DEVICE HAVE BEEN MADE BUT NO DEVICE HAS BEEN RETURNED.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A GALL BLADDER PROCEDURE, THE GASKET FELL INTO THE PATIENT. THE RUBBER PART OF THE TROCAR SEPARATED AND FELL INTO THE PATIENT. THE SURGEON REMOVED THE RUBBER PART FROM THE PATIENT WITHOUT DIFFICULTY, HE USED ANOTHER TROCAR TO COMPLETE THE PROCEDURE. THE PATIENT IS DOING WELL. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BASX BLADELESS TROCAR KDC ETHICON ENDO-SURGERY, LLC. NA H44R68

    Patients

    Seq Age Sex Outcome Treatment
    1