BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOPATH** XCEL* STABILITY SLEEVE FOR BLADELESS TROCAR

    MDR report key: 1802140 · Received August 17, 2010

    Report

    Report Number
    3005075853-2010-04661
    Event Type
    Malfunction
    Date Received
    August 17, 2010
    Date of Event
    July 16, 2010
    Report Date
    July 21, 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
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE ANALYSIS RESULTS OF THE B12LT FOUND THAT THE DEVICE WAS RETURNED IN GOOD VISUAL CONDITION. THE DEVICE WAS FUNCTIONALLY LEAK TESTED AND FAILED DURING INSERTION AND REMOVAL OF THE TEST PROBE THROUGH THE DEVICE. ONE POSSIBLE CAUSE FOR THIS TYPE OF ISSUE IS EXCESSIVE BENDING LOAD AS A RESULTING FROM MANIPULATION OF INSERTED DEVICES. HOWEVER, AN INVESTIGATION HAS BEEN INITIATED TO ADDRESS THE POTENTIAL ROOT CAUSE OF THE REPORTED INSUFFLATIONS ISSUES. THE FINAL QUALITY RELEASE CRITERIA WERE MET BEFORE THIS BATCH WAS RELEASED FOR DISTRIBUTION.

    Additional Manufacturer Narrative · 1

    (B)(4). LEAK TEST FAILED INSERTING AND REMOVING TEST PROBE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DURING A LAPAROSCOPIC GASTRIC BAND PROCEDURE, THE SURGEON WAS USING ONE CB12LT DEVICE. THEY WERE HAVING ISSUES WITH INSUFFLATION DURING THE PROCEDURE. NO ADDITIONAL INFORMATION WAS AVAILABLE TO THE MATERIALS ASSOCIATE CONCERNING THE PROCEDURE.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE PATIENT THAT SINCE THE LAST DEVICE CHANGEOUT, HE HAS FELT A "SHOCK WAVE THROUGH HIS BODY" THAT LASTS A FEW SECONDS. THE PHYSICIAN ELECTED TO REPLACE THE ENTIRE SYSTEM. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    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. NA F4R278

    Patients

    Seq Age Sex Outcome Treatment
    1