BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    12X130MM KII BALLOON BLNT TIP SYS

    MDR report key: 3030443 · Received March 26, 2013

    Report

    Report Number
    2027111-2013-00101
    Event Type
    Malfunction
    Date Received
    March 26, 2013
    Date of Event
    February 13, 2013
    Report Date
    March 26, 2013
    Manufacturer
    APPLIED MEDICAL
    Product Code
    GCJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    RA HAS JUST RECEIVED THE INCIDENT DEVICE AND HAS BEEN ASSIGNED TO ENGINEERING FOR EVALUATION. A FOLLOW-UP REPORT WILL BE SENT UPON COMPLETION OF INVESTIGATION. IN ACCORDANCE TO 21 CFR 803.56, IF WE OBTAIN ADD'L INFO, WHICH WAS NOT KNOWN OR WAS NOT AVAILABLE WHEN THE INITIAL REPORT WAS SUBMITTED, THEN THE SUPPLEMENTAL REPORT WILL BE SUBMITTED TO THE FDA.

    Description of Event or Problem · 1

    LAPAROSCOPIC GASTRECTOMY: "DURING A SURGERY USING A 'DA VINCH' ROBOTIC SURGICAL SYSTEM, THE USER DETECTED THAT A BLACK PIECE WAS DETACHED FROM THE TROCAR. THE PIECE WAS RETRIEVED ON THE SPOT AND THE SURGERY WAS CONTINUED TO BE COMPLETED. THE USER PRESUMES THAT THE RUBBER VALVE WAS CAUGHT WITH THE FORCEPS WHEN THEY WERE INSERTED AND WITHDRAWN. WE HAVE BEEN ASKED BY THE FACILITY TO INVESTIGATE INTO THE CAUSE IN DETAIL AS SOON AS POSSIBLE. THEREFORE, WOULD YOU PLEASE MAKE AN INVESTIGATION OF THE EVENT, INCLUDING THE COMBINED USE OF THE DEVICE WITH THE DA VINCI SYSTEM? (B)(4) HAS CONFIRMED THE FOLLOWING: WE FOUND THAT THE DAMAGED PART OF THE SEPTUM AND THE DETACHED PIECE MATCHED. THERE WAS A CHIP INSIDE OF THE DETACHED PIECE. IT WAS FOUND THAT THE SHIELD HAD TURNED WHITE. IT IS POSSIBLE THAT THE SHIELD WAS DAMAGED WHEN THE FORCEPS OR OTHER THINGS WERE INSERTED INTO IT". PT STATUS: THE PT WAS NOT INJURED AT THE MOMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    124211 12X130MM KII BALLOON BLNT TIP SYS NONE GCJ APPLIED MEDICAL C0R50 1159246

    Patients

    Seq Age Sex Outcome Treatment
    1 DA VINCI ROBOTIC SURGICAL SYSTEM