BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRESTIEGE ATRAUMATIC GRASPER

    MDR report key: 168460 · Received May 20, 1998

    Report

    Report Number
    1921846-1998-00014
    Event Type
    Malfunction
    Date Received
    May 20, 1998
    Report Date
    April 21, 1998
    Manufacturer
    ACUFEX MICROSURGICAL INC.
    Product Code
    GCJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    CUSTOMER REPORTS, THE "TEETH BROKE OFF WHILE PERFORMING SURGERY ON PT". NO INJURY WAS REPORTED; HOWEVER, SURGERY WAS DELAYED 20 MINUTES TO RETRIEVE TEETH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRESTIEGE ATRAUMATIC GRASPER MIS GRASPER GCJ ACUFEX MICROSURGICAL INC. NA 891999

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR