BEUDAMED
    FDA Adverse Event Other Summary report: N

    15X100MM KII OPTICAL ACCESS SYSTEM THREADED

    MDR report key: 2222712 · Received July 26, 2011

    Report

    Report Number
    2027111-2011-00077
    Event Type
    Other
    Date Received
    July 26, 2011
    Date of Event
    July 18, 2011
    Report Date
    July 25, 2011
    Manufacturer
    APPLIED MEDICAL
    Product Code
    GCJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INCIDENT DEVICE ANTICIPATED TO RETURN. A FOLLOW-UP REPORT WILL BE PROVIDED WITHIN 30 DAYS OR UPON COMPLETION OF INVESTIGATION.

    Description of Event or Problem · 1

    INCIDENT AS REPORTED: LAPAROSCOPIC SLEEVE GASTRECTOMY - PER PHONE CALL FROM SURGICAL SERVICES DIRECTOR, "DURING THE MIDDLE OF THE CASE, DR. (B)(6) NOTICED THAT THE TIP OF THE TROCAR WAS BROKEN. HE REMOVED THE TROCAR CANNULA AND WAS ABLE TO LOCATE 1 PIECE OF THE BROKEN CANNULA, HE WAS NOT ABLE TO LOCATE THE 2ND PIECE. A C-ARM WAS BROUGHT IN TO LOCATE THE PIECE VIA X-RAY AND COULD NOT BE LOCATED." PATIENT STATUS: IN RECOVERY AT 5PM (B)(6) 2011 PER SURGICAL SERVICE DIRECTOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 15X100MM KII OPTICAL ACCESS SYSTEM THREADED NONE GCJ APPLIED MEDICAL C0R37 1105707

    Patients

    Seq Age Sex Outcome Treatment
    1 Other