BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MICROLINE SURGICAL LAPAROSCOPIC GRASPER

    MDR report key: 6279058 · Received January 20, 2017

    Report

    Report Number
    MW5067476
    Event Type
    Injury
    Date Received
    January 20, 2017
    Date of Event
    January 14, 2017
    Report Date
    January 20, 2017
    Manufacturer
    MICROLINE
    Product Code
    GCJ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    LAPAROSCOPIC GRASPER TIP BROKE OFF DURING PROCEDURE. INITIAL ATTEMPT TO LOCATE ITEM UNSUCCESSFUL. STAT PORTABLE X-RAY PERFORMED AND LOCATION OF BROKEN PIECE IDENTIFIED AND SURGEON ABLE TO LOCATE AND REMOVE OBJECT WITH LAPAROSCOPIC APPROACH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    49006 MICROLINE SURGICAL LAPAROSCOPIC GRASPER MICROLINE SURGICAL LAPAROSCOPIC GRASPER GCJ MICROLINE 3221

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Required Intervention