BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XCEL DILATING TIP TROCAR

    MDR report key: 3172758 · Received June 17, 2013

    Report

    Report Number
    3005075853-2013-03060
    Event Type
    Injury
    Date Received
    June 17, 2013
    Date of Event
    May 22, 2013
    Report Date
    May 28, 2013
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GCJ
    PMA / PMN Number
    K032676
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE ANALYSIS RESULTS OF THE TROCAR PERFORMED FOUND THAT THE TROCAR WAS RECEIVED WITH THE SLEEVE CANNULA BROKEN. HIGHER MAGNIFICATION VIEW OF THE FRACTURE, NOTE THE DUCTILITY IN THE SURFACE INDICATING THE PART BROKE IN A DUCTILE MODE. THE MATERIAL APPEARS TO HAVE BEEN MOLDED PROPERLY AND THE CANNULA BROKE FROM AN EXCESSIVE SIDE LOAD APPLIED TO THE DEVICE. WE DID NOT RECEIVE A VALID BATCH OR LOT NUMBER FOR THE PRODUCT INVOLVED IN THIS COMPLAINT. THEREFORE, WE WERE UNABLE TO CHECK MANUFACTURING RECORDS FOR ANY RELATED NON-CONFORMANCES.

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION WAS NOT PROVIDED BY THE INITIAL CONTACT. INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME. REP PROVIDED THE FOLLOWING INFORMATION AFTER HE SPOKE TO THE SURGEON: THE SURGEON EXPLAINED THERE WAS NOT AN INSTRUMENT IN THE DEVICE WHEN THE BREAK OCCURRED. THE TROCAR HAD POPPED OUT AND SHE WAS RE-INSERTING IT WHEN IT BROKE. SHE STATED SHE WAS NOT PLACING EXCESSIVE FORCE ON THE TROCAR. THE PATIENT RECOVERED WELL.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A GYN PROCEDURE THE SURGEON HAD PLACED THE PORT INTO THE PATIENT; IT KEPT COMING OUT OF THE TISSUE DUE TO THE PATIENT WAS MORBIDLY OBESE. THEY COULD NOT KEEP THE TROCAR IN THE BELLY OF THE PATIENT DUE TO EXCESS FATTY TISSUE IN THE FASCIA. THE SURGEON TRIED TO PLACE THE CAMERA INTO THE PORT WITHOUT THE OBTURATOR PRESENT DUE TO THE FATTY TISSUE PUSHING UP ON THE DEVICE. THE PORT KEPT POPPING OUT AND THEN THE CANNULA BROKE OFF IN THE SECTION ABOUT THREE RIBS UP ON THE CANNULA FROM THE TOP PORTION OF THE DEVICE. THEY HAD TO CALL IN A GENERAL SURGEON IN AT THAT POINT. THEY CONVERTED TO AN OPEN PROCEDURE. THEY THEN REMOVED THE PORT AND THE BROKEN TROCAR FROM THE PATIENT. THIS PROLONGED THE PROCEDURE OVER AN HOUR. THE PATIENT WAS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    272929 XCEL DILATING TIP TROCAR LAPAROSCOPE, GENERAL AND PLASTIC SURGERY GCJ ETHICON ENDO-SURGERY, LLC. NA ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention