BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KII BALLOON BLUNT TIP SYSTEM

    MDR report key: 2050562 · Received April 6, 2011

    Report

    Report Number
    2050562
    Event Type
    Malfunction
    Date Received
    April 6, 2011
    Date of Event
    March 26, 2011
    Report Date
    April 6, 2011
    Manufacturer
    APPLIED MEDICAL
    Product Code
    GCJ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NC, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    TROCAR, COR50, WAS INSERTED INTO ABDOMEN BUT WOULD NOT HOLD AIR AT BALLOON SITE. ANOTHER TROCAR WAS OPENED, COR47 AND IT ALSO WOULD NOT HOLD AIR. THIRD TROCAR OPENED DID WORK AND PROCEDURE COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KII BALLOON BLUNT TIP SYSTEM TROCAR GCJ APPLIED MEDICAL COR47 1132419
    2 KII BALLOON BLUNT TIP SYSTEM TROCAR GCJ APPLIED MEDICAL COR50 *

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR