BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOPATH** XCEL* STABILITY SLEEVE FOR BLADELESS TROCAR

    MDR report key: 1831614 · Received September 13, 2010

    Report

    Report Number
    3005075853-2010-05213
    Event Type
    Malfunction
    Date Received
    September 13, 2010
    Date of Event
    August 18, 2010
    Report Date
    August 18, 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
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    (B)(4). AFTER SEVERAL REQUESTS, THE DEVICE WAS NOT RECEIVED FOR ANALYSIS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC GASTRIC BYPASS PROCEDURE, ALL SEVEN TROCARS HAD EXCESSIVE LEAKAGE THROUGHOUT THE PROCEDURE. A SECOND INSUFFLATION MACHINE HAD TO BE BROUGHT INTO THE ROOM AND THE PRESSURE LEVEL WAS SENT HIGHER THAN NORMAL. THE PROCEDURE WAS PROLONGED FOR 15 MINUTES. THE SAME TROCARS WERE USED TO COMPLETE THE PROCEDURE. NO ADVERSE CONSEQUENCES REPORTED.

    Description of Event or Problem · 1

    THERE IS NO INDICATION THAT THE PRODUCT CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT. HOWEVER, THIS COMPLAINT IS BEING REPORTED BECAUSE FADING DISPLAY WAS NOT RESOLVED WITH TROUBLESHOOTING.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THE PATIENT WITH THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) SYSTEM HAD AN INFECTION. THE DEVICE WAS EXPLANTED. NO ADVERSE PATIENT EFFECTS HAVE BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOPATH** XCEL* STABILITY SLEEVE FOR BLADELESS TROCAR LAPAROSCOPE, GENERAL AND PLASTIC SURGERY GCJ ETHICON ENDO-SURGERY, LLC. G4TE07

    Patients

    Seq Age Sex Outcome Treatment
    1