BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EIGR WAVEGUIDE

    MDR report key: 4922547 · Received July 13, 2015

    Report

    Report Number
    3011394215-2015-00001
    Event Type
    Malfunction
    Date Received
    July 13, 2015
    Date of Event
    June 8, 2015
    Report Date
    June 12, 2015
    Manufacturer
    INVUITY INC.
    Product Code
    FDG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS NOT RETURNED TO THE MANUFACTURER AND NO LOT NUMBER WAS PROVIDED. BATCH RECORD REVIEW WAS NOT ABLE TO BE PERFORMED SINCE NO LOT NUMBER WAS PROVIDED. NO FURTHER INVESTIGATION CAN BE PERFORMED. THERE WAS NO PATIENT INJURY INVOLVED AS REPORTED BY THE USER FACILITY.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA USER FACILITY MEDWATCH: "A PLASTIC PIECE FROM THE LIGHTED ILLUMINATION (WAVEGUIDE) RETRACTOR BROKE OFF DURING SURGERY."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    453343 EIGR WAVEGUIDE RETRACTOR, FIBEROPTIC FDG INVUITY INC. NP

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR