BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SENSING TIP OBTURATOR

    MDR report key: 107323 · Received July 18, 1997

    Report

    Report Number
    2939738-1997-00027
    Event Type
    Malfunction
    Date Received
    July 18, 1997
    Report Date
    June 19, 1997
    Manufacturer
    ORIGIN MEDSYSTEMS, INC.
    Product Code
    GCJ
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DURING LAPAROSCOPIC SURGERY, 2 SENSING TIP TROCARS ALLEGEDLY FAILED TO RETRACT. THE LOT NUMBERS OF THE PRODUCTS ARE NOT AVAILABLE. THE UNITS WERE NOT RETURNED FOR INVESTIGATION.

    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 Other