BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATRAUMATIC GRASPER

    MDR report key: 96419 · Received June 5, 1997

    Report

    Report Number
    1924654-1997-00006
    Event Type
    Malfunction
    Date Received
    June 5, 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

    Additional Manufacturer Narrative · 1

    REFERENCE MFR. COMPLAINT # AF1997-5-6-35. ACTUAL SAMPLE WAS RETURNED AND EXAMINED MICROSCOPICALLY. THE FIXED JAW OF THE DEVICE WAS BROKEN OFF THE GRASPER ASSEMBLY AND THE MECHANISM THAT HOLDS THE JAW WAS MISSING. INVESTIGATION CONCLUDED NO SIGNS OF ABUSE WERE PRESENT. THE DEVICE MOST PROBABLY BROKE DUE TO OVERLOADING. A REVIEW OF THE LOT HISTORY FOUND THAT AT THE TIME OF MFR THE DEVICE MET ALL SPECIFICATIONS.

    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 PATIENT. THE SURGERY WAS DELAYED FOR APPROXIMATELY 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