BEUDAMED
    FDA Adverse Event Death Summary report: N

    ENDOPATH** XCEL* BLADELESS TROCAR

    MDR report key: 2113666 · Received June 3, 2011

    Report

    Report Number
    3005075853-2011-02281
    Event Type
    Death
    Date Received
    June 3, 2011
    Date of Event
    April 30, 2011
    Report Date
    May 10, 2011
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GCJ
    PMA / PMN Number
    K032676
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DATE SENT: (B)(4) 2011. INFORMATION WAS NOT PROVIDED BY THE INITIAL CONTACT. INFORMATION IS UNAVAILABLE; DEVICE WAS NOT RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC LYMPHOCELE PROCEDURE, THE SURGEON WAS INSERTING THE TROCAR SUPERIOR TO THE UMBILICUS AND COULD NOT GET IT THROUGH THE POSTERIOR SHEATH, SO HE REMOVED THE TROCAR AND USED HIS FINGERS TO BLUNT DISSECTION. THE SURGEON REINSERTED THE TROCAR AND FINISHED THE CASE. IN RECOVERY, THE PATIENT HAD COMPLICATIONS LATER THEN WAS TAKEN BACK TO SURGERY. POST-OP A RUPTURE AT THE ILIAC WAS FOUND, THE PATIENT EXPIRED. HOWEVER, IT IS UNKNOWN WHEN THE PATIENT EXPIRED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Death