BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSTRUMED

    MDR report key: 3731256 · Received February 20, 2014

    Report

    Report Number
    8010372-2014-00001
    Event Type
    Injury
    Date Received
    February 20, 2014
    Date of Event
    October 25, 2013
    Report Date
    February 20, 2014
    Manufacturer
    INSTRUMED INTERNATIONAL, INC.
    Product Code
    GEI
    PMA / PMN Number
    EXEMPT
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICES DESCRIPTION CORRECTED. THIS IS NOT A SINGLE USE DEVICE. DEVICE NOT AVAILABLE FOR EVAL. CLASS 1 EXEMPT. THE DEVICE WAS NOT MADE AVAILABLE FOR EVAL. A DHR REVIEW WAS CONDUCTED AND THERE WERE NO DEVIATIONS NOTED. FURTHER INVESTIGATION IS NOT POSSIBLE.

    Description of Event or Problem · 1

    DURING OPERATIVE PROCEDURE, (CERVICAL DECOMPRESSION) A RHOTON DISSECTOR THAT WAS BEING USED BY THE PHYSICIAN BROKE WHILE INSIDE THE PT. THE PHYSICIAN RETRIEVED THE BROKEN PIECE. X-RAY WAS TAKEN OF PT'S NECK. X-RAY READ AS NO METAL SEEN IN PT. NO HARM TO PT. WHAT WAS THE ORIGINAL INTENDED PROCEDURE. LEFT C5-C6, C6-C7 DECOMPRESSIVE FORAMINOTOMY WITH MICROSCOPIC DISSECTION. DEVICE USAGE PROBLEM: DEVICE FAILED (E.G. BROKE, COULDN'T GET IT TO WORK OR STOPPED WORKING).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    106978 INSTRUMED KNIFE CURETTE, SMALL, ANG, 45 DEGREE GEI INSTRUMED INTERNATIONAL, INC. VM101-4715 120312

    Patients

    Seq Age Sex Outcome Treatment
    1