BEUDAMED
    FDA Adverse Event Injury Summary report: N

    YELLOWPORT

    MDR report key: 1833603 · Received September 8, 2010

    Report

    Report Number
    9680952-2010-00001
    Event Type
    Injury
    Date Received
    September 8, 2010
    Date of Event
    August 10, 2010
    Report Date
    September 7, 2010
    Manufacturer
    SURGICAL INNOVATIONS PLC
    Product Code
    GCJ
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOWING A REVIEW OF THE DEVICE HISTORY RECORD FOR LOT NUMBER 52693 ALL PROCESS AND TEST CRITERIA HAS BEEN VERIFIED AS COMPLYING WITH INTERNAL REQUIREMENTS. THE INVESTIGATION OF LOT NUMBER 526936 CONCLUDED SATISFACTORY PROCESSING AND PACKAGING OF THE DEVICE AND RESULTANT TESTING OF PRODUCT. THERE IS NO EVIDENCE TO SUGGEST ANY REASON FOR POTENTIAL CONCERNS RELATING TO PULL OUT STRENGTH OF THE 5 MM VALVE. PREVIOUS TESTING OF 5MM VALVE SEAL ADHESION CONCLUDED THAT THE SAMPLES TESTED WERE IN EXCESS OF THE MINIMUM PULL OUT STRENGTH, AND CONSISTENTLY SUPPLIED RESULTS IN EXCESS OF THE REQUIRED DEGREE OF STRENGTH WHICH INCORPORATED A SAFETY MARGIN OF 100%.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC COLON RESECTION, THAT WHILE USING THE 5 MM YELLOW PORT TROCARS ONE OF THE DISPOSABLE VALVES BROKE IN HALF AND FELL INSIDE THE PATIENT. THE OTHER PART WAS FOUND INSIDE THE SHAFT OF THE CANNULA. THEY WERE ABLE TO RETRIEVE THE PIECE THAT WAS INSIDE THE PATIENT AND REMOVE IT. IT IS BELIEVED THAT AN X-RAY FOLLOWING THE PROCEDURE WAS CARRIED OUT TO ENSURE THAT NO OTHER PIECES WERE INSIDE THE PATIENT THAT WOULD RESULT IN INJURY. NO ADDITIONAL POST OPERATIVE CARE WAS NECESSARY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 YELLOWPORT LAPAROSCOPIC, GENERAL & PLASTIC SURGERY GCJ SURGICAL INNOVATIONS PLC NA 52693

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other