BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOPATH** XCEL* BLADELESS TROCAR WITH STABILITY SLEEVE

    MDR report key: 1857774 · Received October 6, 2010

    Report

    Report Number
    3005075853-2010-05728
    Event Type
    Malfunction
    Date Received
    October 6, 2010
    Date of Event
    September 13, 2010
    Report Date
    September 13, 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 Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). MELTED SLEEVE THE ANALYSIS RESULTS FOUND THAT THE DEVICE SHOWED DAMAGE AT THE TIP OF THE SLEEVE. ONE POSSIBLE CAUSE FOR THIS TYPE OF DAMAGE MAY BE INTERACTION WITH AN ENERGIZED DEVICE USED DURING THE PROCEDURE. CAUTION SHOULD BE TAKEN TO AVOID CONTACT BETWEEN AN ENERGIZED DEVICE AND THE TROCAR DURING THE SURGICAL PROCEDURE. THE FINAL QUALITY RELEASE CRITERIA WERE MET BEFORE THIS BATCH WAS RELEASED FOR DISTRIBUTION.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A TRAPEZOID RX LITHOTRIPTER COMPATIBLE BASKET WAS USED DURING AN ERCP (ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY) PROCEDURE PERFORMED ON (B)(6), 2010. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, IT WAS NOTED THAT THE OUTER SHEATH OF THE CATHETER PUSHED UP BUT DID NOT COME OFF. THE PROCEDURE WAS COMPLETED WITH ANOTHER TRAPEZOID RX LITHOTRIPTER COMPATIBLE BASKET DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE FINE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC GASTRIC BAND PROCEDURE, AT THE BOTTOM OF THE TROCAR, IT WAS MISSING A CIRCULAR PIECE; IT LOOKS CHIPPED OUT FROM THE SLEEVE. THE PIECE MISSING WAS THE DISTAL END OF THE CANNULA SLEEVE. THE SURGEON NOTICED THE MISSING PIECE AFTER THE TROCAR HAD BEEN INSERTED WHEN THE CAMERA WAS DOWN THE PORT. NO PIECES ARE TO BE BELIEVED TO HAVE FALLEN INTO THE PATIENT. THE SAME TROCAR WAS USED TO COMPLETE THE PROCEDURE. NO ADVERSE CONSEQUENCES REPORTED.

    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 G4TF3J

    Patients

    Seq Age Sex Outcome Treatment
    1