BEUDAMED
    FDA Adverse Event Other Summary report: N

    12X100MM KII Z-THREAD ACC SYS W/SHLD BLD OBTURATOR

    MDR report key: 2464111 · Received February 15, 2012

    Report

    Report Number
    2027111-2012-00024
    Event Type
    Other
    Date Received
    February 15, 2012
    Date of Event
    January 31, 2012
    Report Date
    February 15, 2012
    Manufacturer
    APPLIED MEDICAL
    Product Code
    LZN
    Adverse Event
    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 WITHIN 30 DAYS OR 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

    INCIDENT AS REPORTED: LAPAROSCOPIC HYSTERECTOMY - AFTER INSUFFLATION OF THE ABDOMEN WITH A VERRES NEEDLE, THE FIRST PORT WAS INSERTED (SHIELDED BLADED) AT THE UMBILICUS. ON REMOVAL OF THE OBTURATOR, BLOOD WAS SEEN ON ITS TIP. THIS PROMPTED FURTHER INVESTIGATION WHICH IS DETAILED IN THE ATTACHED WORD DOCUMENT (THIS INFORMATION WAS TAKEN FROM THE (B)(6) SISTER DURING THE CASE, (B)(6)). (B)(4). PATIENT STATUS: FINE. TYPE OF INTERVENTION: LAPAROTOMY PERFORMED TO SUTURE BOWEL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 12X100MM KII Z-THREAD ACC SYS W/SHLD BLD OBTURATOR NONE LZN APPLIED MEDICAL CTB73 1157833/1158301

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention