BEUDAMED
    FDA Adverse Event Other Summary report: N

    15X100MM KII NON-THR OPTICAL ACCESS SYSTEM

    MDR report key: 1400129 · Received June 2, 2009

    Report

    Report Number
    2027111-2009-00050
    Event Type
    Other
    Date Received
    June 2, 2009
    Date of Event
    May 27, 2009
    Report Date
    June 2, 2009
    Manufacturer
    APPLIED MEDICAL RESOURCES CORP.
    Product Code
    GCJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INCIDENT DEVICE WAS SENT TO RISK MGMT WITHIN (B) (6) AND NOT AVAILABLE FOR EVALUATION. APPLIED MEDICAL IS REQUESTING PHOTOS FROM HOSP. A F/U REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    "DR (B) (6) NOTICED AFTER NORMAL TROCAR USE THAT THE TIP OF THE CANNULA HAD PIECES BREAK OFF INTO THE PT'S ABDOMEN. ALL THE PIECES WERE RECOVERED AND NO ADVERSE EFFECT OCCURRED TO THE PT. OPERATION TIME PROBABLY PROLONGED BY APPROXIMATELY 10-15 MINS TO RECOVER PIECES. PT SUFFERED NO INJURY. MERELY LENGTHENED THE PROCEDURE TO RETRIEVE THE PIECES. ALL PIECES WERE RECOVERED OUT OF THE PT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 15X100MM KII NON-THR OPTICAL ACCESS SYSTEM NONE GCJ APPLIED MEDICAL RESOURCES CORP. C0R36 1084426

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention