BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATRAUMATIC GRASPER

    MDR report key: 152016 · Received December 10, 1997

    Report

    Report Number
    1946801-1997-00005
    Event Type
    Malfunction
    Date Received
    December 10, 1997
    Date of Event
    April 11, 1997
    Report Date
    April 15, 1997
    Manufacturer
    ACUFEX MICROSURGICAL, INC.
    Product Code
    GCJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    CUSTOMER REPORTS, DAVIS AND GECK GRASPER BEING USED TO GRASP THE GALL BLADDER IN A LAPAROSCOPIC PROCEDURE. THE TIP BROKE OFF. X-RAY WAS REQUIRED TO LOCATE THE BROKEN TIP. THE TIP WAS RETRIEVED LAPAROSCOPICALLY WITH NO INJURY TO THE PT. THE SURGERY WAS DELAYED FOR APPROX THIRTY MINUTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ATRAUMATIC GRASPER GRASPER GCJ ACUFEX MICROSURGICAL, INC. NA 888053

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR