BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KII 12X100 Z-THR OPT SEP SYS

    MDR report key: 3082569 · Received April 24, 2013

    Report

    Report Number
    2027111-2013-00153
    Event Type
    Malfunction
    Date Received
    April 24, 2013
    Date of Event
    March 13, 2013
    Report Date
    April 24, 2013
    Manufacturer
    APPLIED MEDICAL
    Product Code
    GCJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    RA HAS JUST RECEIVED THE INCIDENT DEVICE AND HAS BEEN ASSIGNED TO ENGINEERING FOR EVALUATION. A FOLLOW-UP REPORT WILL BE SENT 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

    LAPAROSCOPIC CHOLECYSTECTOMY - "THIS IS A COMPLAINT FROM THE MARKET. A SEPTUM WAS BROKEN. AFTER AN OPERATION, THE USER FOUND THAT A SEPTUM WAS BROKEN. THE OPERATION WAS LAPAROSCOPIC CHOLECYSTECTOMY. THE OPERATION WAS COMPLETED WITHOUT A PROBLEM, BUT THE USER FOUND THIS FAULT IN CLEANOUT. (B)(6) CHECKED THE DUCKBILL AND THE SEPTUM. AS A RESULT, WE FOUND THAT THE SEPTUM WAS BROKEN." PATIENT STATUS: THE PATIENT WAS NOT INJURED AT THE MOMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    177506 KII 12X100 Z-THR OPT SEP SYS NONE GCJ APPLIED MEDICAL CTR73 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1