BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    YELLOWPORT

    MDR report key: 3099103 · Received May 1, 2013

    Report

    Report Number
    9680952-2013-00003
    Event Type
    Malfunction
    Date Received
    May 1, 2013
    Date of Event
    April 2, 2013
    Report Date
    April 30, 2013
    Manufacturer
    SURGICAL INNOVATIONS PLC
    Product Code
    GCJ
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE LOT NUMBER REPORTED BY THE HEALTH CARE FACILITY (66514) IS DIFFERENT TO THA REPORTED BY THE DISTRIBUTOR ((B)(4)) AND RELATES TO A DIFFERENT PRODUCT. THEREFORE, THE MFR'S REVIEW WAS CARRIED OUT AGAINST LOT NUMBER 65514. THE DHR WAS REVIEWED FOR LOT 65514, WHICH WAS MANUFACTURED DECEMBER 2012. DEVICE HISTORY RECORD REVIEW OF PRODUCT ASSEMBLY AND PACKAGING WAS RECORDED AS ADHERING TO SPECIFIED REQUIREMENTS FOR FINAL INSPECTION AND RELEASE 9TH DECEMBER 2012. (MFR'S REF. (B)(4)).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE TOP OF THE YELLOWPORT SEAL SEPARATED FROM THE BOTTOM DURING (B)(6) SURGERY. FURTHER INFO RECEIVED (B)(6) 2013 - VOLUNTARY REPORT NO. (B)(4), (B)(6) 2013: DURING LAPAROSCOPIC SURGERY, A SEAL FROM A TROCAR BEING USED WAS RETRIEVED FROM THE PT'S ABDOMEN. THE FOREIGN BODY WAS DISCOVERED AND RETRIEVED. NO HARM TO PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    190024 YELLOWPORT LAPAROSCOPE, GENERAL & PLASTIC SURGERY GCJ SURGICAL INNOVATIONS PLC 65514

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other