BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    USA ELITE RIGID OPTICAL GRASPING FORCEPS

    MDR report key: 4173535 · Received October 10, 2014

    Report

    Report Number
    2951238-2014-00448
    Event Type
    Malfunction
    Date Received
    October 10, 2014
    Date of Event
    August 21, 2014
    Report Date
    September 22, 2014
    Manufacturer
    GYRUS ACMI INC.
    Product Code
    GEN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE REFERENCED IN THIS REPORT HAS NOT YET BEEN RETURNED TO OLYMPUS FOR EVALUATION. THE EXACT CAUSE OF THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED. IF ADDITIONAL INFORMATION IS RECEIVED AT A LATER TIME THIS REPORT WILL BE SUPPLEMENTED.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THAT DURING A PROCEDURE, WHILE THE PHYSICIAN WAS USING THE GRASPING FORCEPS THE TIP BROKE OFF AND FELL INSIDE THE PATIENT. THE PHYSICIAN USED A SECOND FORCEPS AND THE TIP ALSO BROKE OFF. THE BROKEN PIECES WERE RETRIEVED FROM THE PATIENT, THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING A THIRD GRASPING FORCEPS. NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    642572 USA ELITE RIGID OPTICAL GRASPING FORCEPS GRASPING FORCEPS GEN GYRUS ACMI INC. E8215 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other (B)(4)