BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INST 960-539 GUIDE BIOPSY

    MDR report key: 8214314 · Received January 3, 2019

    Report

    Report Number
    1723170-2019-00060
    Event Type
    Malfunction
    Date Received
    January 3, 2019
    Date of Event
    December 6, 2018
    Report Date
    January 21, 2019
    Manufacturer
    MEDTRONIC NAVIGATION, INC
    Product Code
    HAW
    UDI-DI
    00763000055578
    PMA / PMN Number
    K954276
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT INFORMATION WAS REFUSED TO BE PROVIDED BY THE SITE. DEVICE LOT NUMBER, OR SERIAL NUMBER, UNAVAILABLE. THE INSTRUMENT WAS NOT RETURNED, SO NO ANALYSIS WAS CONDUCTED. DEVICE MANUFACTURING DATE IS DEPENDENT ON LOT NUMBER/SERIAL NUMBER, THEREFORE, UNAVAILABLE. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    THE LOT NUMBER WAS PROVIDED. THE UDI WAS CORRECTED. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION DEVICE BEING USED FOR A CRANIAL BIOPSY PROCEDURE. THE ISSUE OCCURRED INTRAOPERATIVELY AND DELAYED THE SURGERY BY 5 MINUTES. IT WAS REPORTED THAT THE SITE HAD A DAMAGED PRECISION AIMING DEVICE AND THE WING WOULD NOT TIGHTEN. THE SURGERY WAS COMPLETED BY OBTAINING A NEW ARTICULATING ARM TRAY AND THERE WAS NO IMPACT ON PATIENT OUTCOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    5156 INST 960-539 GUIDE BIOPSY INSTRUMENT, STEREOTAXIC HAW MEDTRONIC NAVIGATION, INC 960-539 071107 00763000055578

    Patients

    Seq Age Sex Outcome Treatment
    1