BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOPATH** XCEL* BLADELESS TROCAR WITH STABILITY SLEEVE

    MDR report key: 1870188 · Received October 15, 2010

    Report

    Report Number
    3005075853-2010-05882
    Event Type
    Malfunction
    Date Received
    October 15, 2010
    Date of Event
    September 16, 2010
    Report Date
    September 28, 2010
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GCJ
    PMA / PMN Number
    K032676
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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 (SEE PICTURES). 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. IN ADDITION, THE LENS OF THE OBTURATOR WAS NOTED CRACKED AND THE DUCKBILL WAS SLIGHTLY OPEN AT SLIT; HOWEVER, THESE FINDINGS ARE NOT RELATED WITH THE INCIDENT REPORTED. 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

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE, THE TIP OF THE TROCAR'S SLEEVE WAS DISTORTED LIKE IT WAS MELTED. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT.

    Description of Event or Problem · 1

    PER THE CLINIC, THE PATIENT EXPERIENCED A LOSS OF OSSEOINTEGRATION FOUR DAYS POST-OPERATIVELY, RESULTING IN FIXTURE LOSS. THERE ARE NO PLANS TO REIMPLANT THE PATIENT AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOPATH** XCEL* BLADELESS TROCAR WITH STABILITY SLEEVE LAPAROSCOPE, GENERAL AND PLASTIC SURGERY GCJ ETHICON ENDO-SURGERY, LLC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1