BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRESTIGE ATRAUMATIC GRASPER

    MDR report key: 147147 · Received February 4, 1998

    Report

    Report Number
    1946801-1998-00002
    Event Type
    Injury
    Date Received
    February 4, 1998
    Date of Event
    November 12, 1997
    Report Date
    November 17, 1997
    Manufacturer
    ACUFEX MICROSURGICAL, INC.
    Product Code
    GCJ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    CUSTOMER REPORTS, DURING A LAPAROSCOPIC CHOLECYSTECTOMY THE JAW OF THE INSTRUMENT BROKE (FELL APART IN SEVERAL PIECES.) THE SURGEON WAS UNABLE TO RETRIEVE THE PIECES AND CONVERTED TO AN OPEN PROCEDURE, DURING WHICH THE LAST PIECE WAS REMOVED. THE PT IS FINE. HOWEVER, HE WAS HOSPITALIZED FOR FOUR DAYS POST-OP DUE TO THE OPEN PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRESTIGE ATRAUMATIC GRASPER GRASPER GCJ ACUFEX MICROSURGICAL, INC. NA L888-168

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Hospitalization| R