BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SENSING TIP OBTURATOR

    MDR report key: 102821 · Received June 28, 1997

    Report

    Report Number
    2939738-1997-00020
    Event Type
    Malfunction
    Date Received
    June 28, 1997
    Report Date
    May 29, 1997
    Manufacturer
    ORIGIN MEDSYSTEMS, INC.
    Product Code
    GCJ
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS A FOLLOW-UP REPORT TO REPORT # 2939738-1997-00020. THE UNIT WAS RETURNED OT ORIGIN FOR INVESTIGATION, THE RETRACTION TROCAR WAS NOT. IT WAS REPORTED THAT THE CUSTOMER DID NOT HEAR OF FEEL THE OBTURATOR RETRACTING WHEN IT TOUCHED THE TISSUE. THE CANNULA WAS THE ONLY UNIT AVAILABLE FOR INVESTIGATION. A 10MM SENSING TIP WAS TRIED WITH THE UNIT AND IT HAS WORKED PROPERLY. NO BURRS OR DEFORMATION OBSERVED ON THE TIP OF THE CANNULLA THAT WOULD INTERFERE WITH THE FUNCTION. NO CAUSE OF FAILURE COULD BE DETERMINE FROM THE RETURNED UNIT. COULD NOT CONFIRM THE FAILURE FROM THE RETURNED UNIT. IT IS POSSIBLE THAT THE PRODUCT WAS NOT PROPERLY HANDLED DURING INSERTION. A NOTE HAS BEEN ADDED TO THE IFU THROUGH AN ECO #3149 TO INCLUDE THE INSTRUCTIONS FOR PROPER HANDLING OF THE PRODUCT. EXPECTED IMPLEMENTATION BY 9/1/97.

    Description of Event or Problem · 1

    DURING A LAPAROTOMY FOR AN OVARIAN CYST REMOVAL, THE SENSING TROCAR ALLEGEDLY WAS NOT HEARD OR FELT RETRACT AFTER IT WAS INSERTED. THE TROCAR CANNULA WAS BEING USED IN CONJUNCTION WITH THE RETRACTION TROCAR AT THE TIME.

    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