BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SENSING TIP TROCAR

    MDR report key: 105647 · Received July 9, 1997

    Report

    Report Number
    2939738-1997-00025
    Event Type
    Malfunction
    Date Received
    July 9, 1997
    Report Date
    June 9, 1997
    Manufacturer
    ORIGIN MEDSYSTEMS, INC.
    Product Code
    GCJ
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE SENSING TIP TROCAR ALLEGEDLY DIDN'T FEEL RIGHT, IT FAILED TO RETRACT. THE DEVICE WAS NOT USED IN THE SURGERY. THE PHYSICIAN DIDN'T FEEL COMFORTABLE WITH THE UNIT. THE DEVICE HISTORY REVIEW INDICATED THERE WAS NO LOT SPECIFIC PROBLEM. ADD'L LABELING INSTRUCTIONS HAVE BEEN INCLUDED IN THE INSTRUCTIONS FOR USE FOR PROPER HANDLING OF THE PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SENSING TIP TROCAR RETRACTION TROCAR GCJ ORIGIN MEDSYSTEMS, INC. OMS-T5S 0704971

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other