BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SNOWDEN-PENCER LAPAROSCOPIC RAPTOR GRASPER

    MDR report key: 3896452 · Received June 3, 2014

    Report

    Report Number
    3896452
    Event Type
    Malfunction
    Date Received
    June 3, 2014
    Date of Event
    May 2, 2014
    Report Date
    June 3, 2014
    Manufacturer
    CAREFUSION 2200 INC
    Product Code
    GCJ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    IL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    LAPARASCOPIC GRASPER BROKE WHILE INSIDE THE PATIENT. TWO PIECES WERE LOCATED BUT UNSURE IF ALL PRIECES WERE ACCOUNTED FOR. X-RAY INCONCLUSIVE FOR MISSING PARTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    325328 SNOWDEN-PENCER LAPAROSCOPIC RAPTOR GRASPER LAPAROSCOPIC ACCESSORIES GCJ CAREFUSION 2200 INC * *

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR LAPAROSCOPIC INSTRUMENTS