BEUDAMED
    FDA Adverse Event Summary report: N

    5X100MM KII SLEEVE ADVANCED FIXATION 12/BX

    MDR report key: 3032594 · Received March 29, 2013

    Report

    Report Number
    2027111-2013-00114
    Date Received
    March 29, 2013
    Date of Event
    March 1, 2013
    Report Date
    March 28, 2013
    Manufacturer
    APPLIED MEDICAL
    Product Code
    GCJ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    RA HAS 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 IN THE FDA.

    Description of Event or Problem · 1

    LAVH - "LOSS OF INFLATION. PRIOR TO THIS, THERE WERE ISSUES OF OVER INSUFFLATION PROBABLY DUE TO THE INSUFFLATION DEVICE BEING DEFECTIVE. SURG. ALSO USED A CORK SCREW INSTRUMENT WHICH WAS BENT IN PATIENT DURING OPERATING ROOM. THE TIP OF CANNULA HAS SOME DAMAGE DUE TO ATTEMPTING TO REMOVE THE INSTRUMENT." PATIENT STATUS: GOOD. TYPE OF INTERVENTION: SURGEON RESORTED TO REMOVING THE UTERUS TRANS VAGINALLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    130367 5X100MM KII SLEEVE ADVANCED FIXATION 12/BX NONE GCJ APPLIED MEDICAL CFS02 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention