BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    *

    MDR report key: 2250760 · Received September 13, 2011

    Report

    Report Number
    2250760
    Event Type
    Malfunction
    Date Received
    September 13, 2011
    Date of Event
    August 24, 2011
    Report Date
    September 13, 2011
    Manufacturer
    AESCULAP A DIVISION OF BBRAUN
    Product Code
    GCJ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    RI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    SURGEON WAS USING A GRASPER DURING LAPAROSCOPIC CHOLECYSTECTOMY WHEN ONE PIECE OF THE GRASPER BROKE APART FROM THE INSTRUMENT AND FELL INTO THE PATIENT'S ABDOMEN. IT WAS RETRIEVED BY THE SURGEON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 * RETRACTION GRASPER GCJ AESCULAP A DIVISION OF BBRAUN 8361-00 *

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR