BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    12X100MM KII BALLOON BLUNT TIP SYSTEM

    MDR report key: 3050292 · Received April 5, 2013

    Report

    Report Number
    2027111-2013-00119
    Event Type
    Malfunction
    Date Received
    April 5, 2013
    Date of Event
    March 20, 2013
    Report Date
    April 5, 2013
    Manufacturer
    APPLIED MEDICAL
    Product Code
    GCJ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INCIDENT DEVICE ANTICIPATED TO RETURN. A FOLLOW-UP REPORT WILL BE PROVIDED UPON COMPLETION OF INVESTIGATION. IN ACCORDANCE TO 21 CFR 803.56, IF WE OBTAIN ADDITIONAL INFORMATION, 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

    LAPAROSCOPY: "DURING INTRODUCTION OF THE OPTICAL, THE WIRE THAT HOLDS THE BALLOON TROCAR UNRAVELED. THE LENS HAS NOT PIERCED THE APONEUROSIS, AND THE SURGEON HAS REMOVED ALL THE FILAMENTS." PATIENT STATUS: OK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    139664 12X100MM KII BALLOON BLUNT TIP SYSTEM NONE GCJ APPLIED MEDICAL C0R47 1185158

    Patients

    Seq Age Sex Outcome Treatment
    1