BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRESTIGE ATRAUMATIC GRASPER

    MDR report key: 169755 · Received May 28, 1998

    Report

    Report Number
    1921846-1998-00015
    Event Type
    Malfunction
    Date Received
    May 28, 1998
    Date of Event
    January 7, 1998
    Report Date
    April 29, 1998
    Manufacturer
    ACUFEX MICROSURGICAL INC.
    Product Code
    GCJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    ENDOGRASPER BROKE AND A PIECE OF GRASPER FELL INTO PT WHEN USE OF INSTRUMENT WAS ATTEMPTED. SURGEON WAS UNABLE TO FIND BROKEN PIECE, IT REMAINS IN PT. PT WAS HAVING A LAPAROSCOPIC CHOLECYSTECTOMY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRESTIGE ATRAUMATIC GRASPER MIS GRASPER GCJ ACUFEX MICROSURGICAL INC. NA 891928

    Patients

    Seq Age Sex Outcome Treatment
    1 22 YR