BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROXIMATE ILS CURVED CIR STAPL

    MDR report key: 2243280 · Received September 12, 2011

    Report

    Report Number
    3005075853-2011-03728
    Event Type
    Malfunction
    Date Received
    September 12, 2011
    Date of Event
    August 23, 2011
    Report Date
    August 25, 2011
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K983536
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DAMAGED ANCILLARY TROCAR. THE ANCILLARY TROCAR WAS RECEIVED BROKEN. THE ANALYSIS RESULTS FOUND THAT AN ANCILLARY TROCAR WAS RECEIVED WITHOUT A DEVICE. THE TIP OF THE ANCILLARY TROCAR WAS BROKEN OFF AND MISSING. NO FUNCTIONAL TEST COULD BE PERFORMED. IT COULD NOT BE ASCERTAINED AS TO HOW THE DAMAGE TO THE ANCILLARY TROCAR OCCURRED WITH THE INFORMATION PROVIDED. IT SHOULD BE NOTED THAT IF TORQUE OR EXCESS FORCE IS APPLIED TO THE ANCILLARY TROCAR, IT MAY CAUSE THE TROCAR TO BREAK. AS PART OF OUR QUALITY PROCESS, EACH DEVICE IS VISUALLY INSPECTED AND FUNCTIONALLY TESTED DURING MANUFACTURING TO ENSURE THAT THE DEVICE MEETS THE REQUIRED SPECIFICATIONS PRIOR TO SHIPMENT. A BATCH RECORD REVIEW WAS PERFORMED AND NO ANOMALIES WERE FOUND DURING THE MANUFACTURING PROCESS.

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION WAS NOT PROVIDED BY THE INITIAL CONTACT. INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN OPEN ESOPHAGECTOMY, THE BLUE TROCAR TIP WAS BROKEN OFF WHEN IT WAS REMOVED FROM THE SPACER TAB. 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 PROXIMATE ILS CURVED CIR STAPL STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. NA F4PT24

    Patients

    Seq Age Sex Outcome Treatment
    1