BEUDAMED
    FDA Adverse Event Injury Summary report: N

    12X100MM KII FIOS ADVANCED FIXATION SYSTEM

    MDR report key: 1723804 · Received June 9, 2010

    Report

    Report Number
    2027111-2010-00070
    Event Type
    Injury
    Date Received
    June 9, 2010
    Date of Event
    May 12, 2010
    Report Date
    June 9, 2010
    Manufacturer
    APPLIED MEDICAL RESOURCES CORP.
    Product Code
    GCJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THERE WAS NO PRODUCT RETURN AND NO LOT # PROVIDED. INCIDENT IS UNDERGOING ENGINEERING EVAL.

    Description of Event or Problem · 1

    INCIDENT AS REPORTED: ROBOT ASSISTED LAPAROSCOPIC PHYLOPLASTY - "SURGEON INSERTED TROCAR INTO AN INSUFFLATED ABDOMEN AND LACERATED THE PT'S ILIAC ARTERY. THIS RESULTED IN THE SURGEON HAVING TO CONVERT THE PROCEDURE TO OPEN. SURGEON CLAIMED THAT HE HAD LOST CONTROL OF THE PORT DURING INSERTION INTO THE PERITONEAL CAVITY."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 12X100MM KII FIOS ADVANCED FIXATION SYSTEM NONE GCJ APPLIED MEDICAL RESOURCES CORP. CFF73

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization