BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SENSING TIP OBTURATOR

    MDR report key: 93807 · Received May 22, 1997

    Report

    Report Number
    2939738-1997-00018
    Event Type
    Malfunction
    Date Received
    May 22, 1997
    Report Date
    April 24, 1997
    Manufacturer
    ORIGIN MEDSYSTEMS, INC.
    Product Code
    HET
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DURING A LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE, THE SURGICAL TROCAR ALLEGEDLY FAILED TO RETRACT. THE ALLEGED FAILURE COULD NOT BE DUPLICATED. THE DEVICE HISTORY RECORD REVIEW INDICATED THERE WAS NO RELEVANT LOT SPECIFIC PROBLEM. THE QE FOUND THAT IT IS VERY LIKELY THAT THE PRODUCT WAS NOT PROPERLY HANDLED BY THE USER DURING THE INSERTION. A NOTE HAS BEEN ADDED TO THE IFU TO INCLUDE ADDITIONAL CLARIFICATION FOR THE HANDLING OF THE PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SENSING TIP OBTURATOR RETRACTION TROCAR HET ORIGIN MEDSYSTEMS, INC. OMS-T10S0 1411961

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other