BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOPATH** XCEL* TROCAR

    MDR report key: 1983484 · Received February 10, 2011

    Report

    Report Number
    3005075853-2011-00538
    Event Type
    Injury
    Date Received
    February 10, 2011
    Date of Event
    December 12, 2010
    Report Date
    December 14, 2010
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GCJ
    PMA / PMN Number
    K032676
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION IS UNAVAILABLE; DEVICE WAS NOT RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC APPENDECTOMY PROCEDURE, THE PATIENT EXPERIENCED AN ARC, LEADING TO AN ILEUM BURN. THE L-HOOK WAS INVESTIGATED, AND IT WAS NOTICED THE INSULATE HAD SHEARED FROM THE SHAFT. A SECOND L-HOOK, SAME BRAND WAS OPENED. ONCE AGAIN, IT WAS NOTED THAT THE INSULATE HAD SHEARED. AT THIS STAGE, A STAFF MEMBER IN THE THEATRE SUGGESTED THE INSTRUMENT WAS IMPACTING WITH THE TROCAR SHEATH. THE TWO TROCARS HAVE BEEN RETAINED BY THE HOSPITAL FOR THIS INQUIRY. UNKNOWN HOW CASE WAS COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOPATH** XCEL* TROCAR LAPAROSCOPE, GENERAL AND PLASTIC SURGERY GCJ ETHICON ENDO-SURGERY, LLC. NA G4TR63

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention MONOPOLAR L-HOOK