BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KII 5X100 ZPTHR CANNULA/SEAL 12/BOX

    MDR report key: 3131487 · Received February 25, 2013

    Report

    Report Number
    2027111-2013-00055
    Event Type
    Malfunction
    Date Received
    February 25, 2013
    Date of Event
    May 3, 2012
    Report Date
    February 22, 2013
    Manufacturer
    APPLIED MEDICAL
    Product Code
    GCJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS INCIDENT WAS NOT REPORTED TO APPLIED MEDICAL. WE LOCATED THIS REPORT ON A (B)(6) REPORT WEBSITE; HOWEVER THE (B)(4) REPORT DID NOT CONTAIN THE HOSPITAL NAME HENCE WE COULD NOT REQUEST MORE INFORMATION OR THE RETURN OF THE EVENT SAMPLE FOR OUR INVESTIGATION. A DEVICE HISTORY REPORT OF THE INCIDENT WILL BE CONDUCTED AND A FOLLOW-UP REPORT WILL BE SENT UPON COMPLETION OF THE EVALUATION.

    Description of Event or Problem · 1

    "THROUGHOUT PROCEDURE, THE DOCTOR WAS HAVING PROBLEMS WITH THE 5MM SLEEVE. THE 5MM SLEEVE DID NOT HAVE A SEAL THAT LASTED THE WHOLE CASE AND WAS LETTING THE CO2 OUT OF THE PORT. ANOTHER SLEEVE HAD TO BE OPENED AND INSERTED INTO THE PT. THIS KEPT THE PT UNDER ANESTHESIA FOR A GREATER LENGTH OF TIME."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    81146 KII 5X100 ZPTHR CANNULA/SEAL 12/BOX NONE GCJ APPLIED MEDICAL CTS02 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1