BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SENSING TIP OBTURATOR

    MDR report key: 117659 · Received September 4, 1997

    Report

    Report Number
    2939738-1997-00030
    Event Type
    Malfunction
    Date Received
    September 4, 1997
    Report Date
    August 5, 1997
    Manufacturer
    ORIGIN MEDSYSTEMS, INC.
    Product Code
    GCJ
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    DURING A LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE, THE SENSING TIP OBTURATOR ALLEGEDLY FAILED TO RETRACT. DEVICE HISTORY ANALYSIS COULD NOT BE PERFORMED SINCE THE PRODUCT'S LOT NUMBER WAS NOT AVAILABLE.

    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