BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SENSING TIP OBTURATOR

    MDR report key: 120124 · Received September 12, 1997

    Report

    Report Number
    2939738-1997-00031
    Event Type
    Malfunction
    Date Received
    September 12, 1997
    Report Date
    July 9, 1997
    Manufacturer
    ORIGIN MEDSYSTEMS, INC.
    Product Code
    GCJ
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DURING A LAPAROSCOPIC PROCEDURE, IT WAS ALLEGED THAT A SENSING TIP OBTURATOR BROKE. THE PT SUFFERED NO KNOWN SERIOUS CONSEQUENCES. ORIGIN RECEIVED THE ALLEGED REPORT ON 7/9/97. AT THAT TIME, THE RPTR'S ALLEGED COMPLAINT READ, "OBTURATOR IS BROKEN." BASED ON THE REPORTED INFO, THE CO DECIDED NOT TO FILE A MEDWATCH REPORT. THE PRODUCT WAS THEN RECEIVED AT ORIGIN ON 8/13/97. AFTER FURTHER INVESTIGATION OF THE UNIT, THE CO BELIEVES THAT THIS INCIDENT SHOULD HAVE BEEN REPORTED. THEREFORE, THE CO IS FILING THIS REPORT AS A MALFUNCTION THAT WOULD HAVE BEEN LIKELY TO CAUSE OR CONTRIBUTE TO A SERIOUS INJURY.

    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