BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XCEL DILATING TIP

    MDR report key: 1904432 · Received November 22, 2010

    Report

    Report Number
    3005075853-2010-06617
    Event Type
    Malfunction
    Date Received
    November 22, 2010
    Date of Event
    October 27, 2010
    Report Date
    October 27, 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 Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION IS UNAVAILABLE; DEVICE WAS NOT RETURNED FOR EVALUATION. THE DEVICE WAS NOT RETURNED FOR ANALYSIS. THERE WAS A PACKAGING LOT NUMBER PROVIDED BY THE USER FACILITY HOWEVER THE NUMBER PROVIDED IS INVALID AND NO DEVICE HISTORY REVIEW WAS ABLE TO BE PERFORMED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE, THE TROCAR WAS LEAKING. IT IS UNKNOWN HOW THE PROCEDURE WAS COMPLETED. NO PATIENT IMPACT REPORTED. TROCAR WAS DISCARDED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1