BEUDAMED
    FDA Adverse Event Other Summary report: N

    ATRAUMATIC GRASPER

    MDR report key: 19960 · Received February 24, 1995

    Report

    Report Number
    MW1005217
    Event Type
    Other
    Date Received
    February 24, 1995
    Date of Event
    February 6, 1995
    Report Date
    February 8, 1995
    Manufacturer
    DAVIS & GECK, INC.
    Product Code
    GEN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    DURING LAPAROSCOPIC PROCEDURE, INSTRUMENT CAME APART IN THE ABDOMEN, IN 2 PIECES. THE INSIDE PIECE OF THE INSTRUMENT APPEARED TO HAVE GROSS CONTAMINATION, RESIDUE FROM PREVIOUS USE. AN INTRA-OPERATIVE X-RAY WAS REQUIRED TO DEMONSTRATE NO RETENTION OF FOREIGN BODY. THIS RESULTED IN LONGER ANESTHESIA AND OR TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ATRAUMATIC GRASPER ATRAUMATIC GRASPER GEN DAVIS & GECK, INC. 8360-00

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Other