BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    YELLOPORT

    MDR report key: 2961217 · Received February 8, 2013

    Report

    Report Number
    9680952-2013-00002
    Event Type
    Malfunction
    Date Received
    February 8, 2013
    Date of Event
    November 21, 2012
    Report Date
    February 7, 2013
    Manufacturer
    SURGICAL INNOVATIONS PLC
    Product Code
    GCJ
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOWING A REVIEW OF THE DEVICE HISTORY RECORD FOR LOT NUMBER 61230 ALL PROCESS AND TEST CRITERIA HAS BEEN VERIFIED AS COMPLYING WITH INTERNAL REQUIREMENTS. THE INVESTIGATION OF LOT NUMBER 61230 CONCLUDED SATISFACTORY PROCESSING AND PACKAGING OF THE DEVICE AND RESULTANT TESTING OF PRODUCT. THE DEVICE EVALUATION CONCLUDED THAT THE BLUE SEAL BREAKING MY HAVE BEEN ATTRIBUTED TO INSUFFICIENT LUBRICANT OR THE DEVICE USED THROUGH THE SEAL COULD HAVE BEEN SLIGHTLY LARGER THAN THE SEAL. THE INITIAL REPORT OF THE BROKEN SEAL REPORTED TO SURGICAL INNOVATIONS INDICATED THAT THE BROKEN PIECE HAD BEEN RETRIEVED AND THERE WAS NO INJURY TO PATIENT. AS REPORT (B)(4) STATES THAT HALF OF IT COULD NOT BE FOUND. A CLINICAL OPINION WAS SOURCED FROM SURGICAL INNOVATIONS (B)(4) WHO ADVISED IT IS IMPORTANT TO ENSURE THAT THE VALVE AND SEAL ARE ADEQUATELY LUBRICATED TO REDUCE FRICTION BECAUSE WHILST THE FRICTION OF A LUBRICATED INSTRUMENT AGAINST THE SEAL IS VERY LOW, IT CAN BECOME VERY HIGH IF THE INSTRUMENT AND SEAL ARE DRY. THE FACT THAT THE SEAL HAS BROKEN IS USUALLY IMMEDIATELY APPARENT TO THE SURGEON BECAUSE THERE IS A NOTICEABLE GAS LEAK, AND (B)(4) EXPERIENCE THE PIECE OF SEAL WOULD BE CLEARLY VISIBLE AND EASILY REMOVED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE 10M BLUE SEAL REDUCER WAS BREAKING. FURTHER INFORMATION RECEIVED (B)(6) 2013 - (B)(4) VOLUNTARY REPORT (B)(6)2013: PORT OF YELLOPORT FROM SURGICAL INNOVATIONS IS A PROBLEM. DISCOVERED BLUE PLASTIC RIM BROKEN, WERE ABLE TO FIND ON SMALL PIECE ON PATIENT'S ABDOMEN, BUT HALF OF IT NOT FOUND. COULD HAVE BEEN SUCTIONED INTO SUCTION IRRIGATOR, BUT COULD BE IN THE ABDOMEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    54633 YELLOPORT LAPAROSCOPE, GENERAL & PLASTIC SURGERY GCJ SURGICAL INNOVATIONS PLC 61230

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other