BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOPATH** XCEL

    MDR report key: 1811615 · Received August 23, 2010

    Report

    Report Number
    3005075853-2010-04789
    Event Type
    Malfunction
    Date Received
    August 23, 2010
    Report Date
    June 23, 2010
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GCJ
    PMA / PMN Number
    K032676
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). MELTED SLEEVE. THE ANALYSIS RESULTS FOUND THAT THE DEVICE SHOWED DAMAGE AT THE TIP OF THE SLEEVE. ONE POSSIBLE CAUSE FOR THIS TYPE OF DAMAGE MAY BE INTERACTION WITH AN ENERGIZED DEVICE USED DURING THE PROCEDURE. CAUTION SHOULD BE TAKEN TO AVOID CONTACT BETWEEN AN ENERGIZED DEVICE AND THE TROCAR DURING THE SURGICAL PROCEDURE. 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 A LAPAROSCOPIC COLON PROCEDURE, THE TIP MELTED OFF THE TROCAR AND NO PIECES FELL INTO THE PATIENT. A HARMONIC WAS BEING USED AT THE SAME TIME, HOWEVER, THE SURGEON MENTIONED THAT THE TWO DEVICES DID NOT COME IN CONTACT WITH EACH OTHER. ANOTHER TROCAR WAS USED TO COMPLETE THE PROCEDURE. NO ADVERSE CONSEQUENCES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOPATH** XCEL LAPAROSCOPE, GENERAL AND PLASTIC SURGERY GCJ ETHICON ENDO-SURGERY, LLC. NA G4RN3C

    Patients

    Seq Age Sex Outcome Treatment
    1