BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SENSING TIP OBTURATOR

    MDR report key: 103852 · Received July 3, 1997

    Report

    Report Number
    2939738-1997-00023
    Event Type
    Malfunction
    Date Received
    July 3, 1997
    Report Date
    June 4, 1997
    Manufacturer
    ORIGIN MEDSYSTEMS, INC.
    Product Code
    GCJ
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DURING A LAPAROSCOPIC-ASSISTED VAGINAL HYSTEROSCOPY PROCEDURE, THE TROCAR ALLEGEDLY FAILED TO RETRACT. THERE WAS NO LOT NUMBER INFO AVAILABLE. A NOTE HAS BEEN ADDED TO THE INSTRUCTIONS FOR USE TO EMPHASIZE THE PROPER HANDLING OF THE PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SENSING TIP OBTURATOR RETRACTION TROCAR GCJ ORIGIN MEDSYSTEMS, INC. OMS-T10SO UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN