BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRESTIEGE ATRAUMATIC GRASPER

    MDR report key: 159970 · Received March 27, 1998

    Report

    Report Number
    1921846-1998-00007
    Event Type
    Malfunction
    Date Received
    March 27, 1998
    Report Date
    February 25, 1998
    Manufacturer
    ACUFEX, MICROSURGICAL, INC.
    Product Code
    GCJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    CUSTOMER REPORTS, A PT UNDERWENT A LAPAROSCOPIC CHOLECYSTECTOMY. DURING THE PROCEDURE THE JAW OF THE DEVICE BROKE OFF AND FELL INTO THE PT'S ABDOMEN. AN X-RAY WAS NECESSITATED TO LOCATE THE BROKEN PART, WHICH WAS RETRIEVED USING ANOTHER GRASPER. THE SURGICAL PROCEDURE WAS DELAYED FOR APPROXIMATELY THIRTY MINUTES. THERE WAS NO INJURY, COMPLICATION OR SEQUELA IDENTIFIED IN THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRESTIEGE ATRAUMATIC GRASPER MIS INSTRUMENT GCJ ACUFEX, MICROSURGICAL, INC. NA 888199

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN