BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INST 960-539 GUIDE BIOPSY

    MDR report key: 9940719 · Received April 8, 2020

    Report

    Report Number
    1723170-2020-01187
    Event Type
    Malfunction
    Date Received
    April 8, 2020
    Date of Event
    March 20, 2020
    Report Date
    May 8, 2020
    Manufacturer
    MEDTRONIC NAVIGATION, INC
    Product Code
    HAW
    UDI-DI
    00681490991520
    PMA / PMN Number
    K954276
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    NO DEVICES WERE RETURNED TO THE MANUFACTURER FOR ANALYSIS. DEVICE MANUFACTURING DATE IS UNAVAILABLE. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    ANALYSIS ON THE RETURNED BIOPSY GUIDE RESULTED IN A MECHANICAL DAMAGE FAILURE THAT WAS FOUND. ANALYSIS STATES THAT THE LOWER JOINT IS DIFFICULT TO LOCK DOWN. 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 SYSTEM USED DURING AN UNKNOWN PROCEDURE. IT WAS REPORTED THAT DURING A CLINICAL CASE THE SITE WAS HAVING ISSUES WITH THE PAD AS IT WAS NOTED THE SECOND WINGNUT ON THE DEVICE WAS TO HARD TO TURN AND TIGHTEN. THE SITE HAD TO USE A LARGE AMOUNT OF FORCE UNTIL IT WAS ABLE TO BE USED. THE CLINICAL SPECIALIST IS REQUESTING A QUOTE FOR REPLACEMENT. PATIENT WAS PRESENT. THERE WAS A LESS THAN 5 MIN DELAY NOTED IN THE CASE. NEW INFORMATION RECEIVED: THE TYPE OF SURGICAL PROCEDURE IS CRANIAL BIOPSY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    397805 INST 960-539 GUIDE BIOPSY INSTRUMENT, STEREOTAXIC HAW MEDTRONIC NAVIGATION, INC 960-539 111111 00681490991520

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR