BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    JARIT

    MDR report key: 1862052 · Received September 27, 2010

    Report

    Report Number
    1862052
    Event Type
    Malfunction
    Date Received
    September 27, 2010
    Date of Event
    September 17, 2010
    Report Date
    September 23, 2010
    Manufacturer
    INTEGRA SURGICAL
    Product Code
    HDC
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NC, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    SURGEON WAS USING THE L/S SINGLE TOOTH TENACULUM DURING THE LAPAROSCOPIC SUPRACERVICAL HYSTERECTOMY PROCEDURE AND THE TIP OF THE INSTRUMENT FELL APART. ALL PIECES WERE RETRIEVED LAPAROSCOPICALLY.====================== HEALTH PROFESSIONAL'S IMPRESSION======================UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 JARIT TENACULUM HDC INTEGRA SURGICAL N/A *

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR