BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOPATH** XCEL* BLADELESS TROCAR WITH STABILITY SLEEVE

    MDR report key: 1870185 · Received October 15, 2010

    Report

    Report Number
    3005075853-2010-05881
    Event Type
    Malfunction
    Date Received
    October 15, 2010
    Date of Event
    September 21, 2010
    Report Date
    September 22, 2010
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GCJ
    PMA / PMN Number
    K032676
    Removal / Correction Number
    UNK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME. (B)(4)

    Additional Manufacturer Narrative · 1

    (B)(4). THE RETURNED PRODUCT HAS BEEN IDENTIFIED AS PART OF THE VOLUNTARY RECALL OF ENDOPATH XCEL WITH OPTIVIEW TECHNOLOGY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC GASTRIC BYPASS PROCEDURE, THE TROCAR LEAKED. THE SURGEON TRIED TO TAKE OFF THE SEAL AND PUT ON AGAIN BUT IT DIDN`T HELP. THEY SWITCHED TO COMPETITOR'S TROCAR. AS A RESULT OF THE DIFFICULTIES ENCOUNTERED WITH THIS DEVICE, THE PROCEDURE WAS PROLONGED EIGHT MINUTES. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT.

    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. NA G4TK2F

    Patients

    Seq Age Sex Outcome Treatment
    1