BEUDAMED
    FDA Adverse Event Summary report: N

    JARIT

    MDR report key: 2940996 · Received December 6, 2006

    Report

    Report Number
    2940996
    Date Received
    December 6, 2006
    Date of Event
    October 11, 2006
    Report Date
    December 4, 2006
    Manufacturer
    JARIT: INTEGRA LIFESCIENCES CORPORATION
    Product Code
    GCJ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    OK, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    UTERUS GRASPED WITH 5 MM LAPAROSCOPIC TENACULUM WHICH HAD 2 PIECES BREAK OFF INSIDE OF ABDOMINAL CAVITY. ONE PIECE WAS RETRIEVED. SECOND PIECE COULD NOT BE RETRIEVED. PATIENT POSITIONS CHANGED FREQUENTLY TO DETERMINE LOCATION OF THE SECOND PIECE. X-RAY TAKEN INTRA-OPERATIVELY; SECOND PIECE LOCATED ON X-RAY. INCISION MADE TO LOOK ONE MORE TIME; THIS WAS UNSUCCESSFUL. A MINI-LAPAROTOMY WAS PERFORMED AND THE SECOND PIECE WAS FINALLY RETRIEVED. ESTIMATED BLOOD LOSS WAS 100 ML. NO OTHER COMPLICATIONS OTHER THAN THE MINI-LAPAROTOMY AND EXTENDED HOSPITAL STAY. PATIENT AND FAMILY WERE KEPT INFORMED REGARDING THE SITUATION DURING THE ENTIRE PROCEDURE. SEE SCANNED PAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 JARIT LAPRASCOPIC 5 MM TENACULUM GCJ JARIT: INTEGRA LIFESCIENCES CORPORATION 615-152

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Hospitalization| R