BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FHC WAYPOINT STEREOTACTIC SYSTEM

    MDR report key: 10756146 · Received October 29, 2020

    Report

    Report Number
    3002250546-2020-00005
    Event Type
    Malfunction
    Date Received
    October 29, 2020
    Date of Event
    September 28, 2020
    Report Date
    October 28, 2020
    Manufacturer
    FHC, INC.
    Product Code
    HAW
    UDI-DI
    00873263005989
    PMA / PMN Number
    K092192
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PHYSICIAN STATED THAT HE HAD A SAFETY CONCERN REGARDING THE FHC MULTI OBLIQUE DUAL TRAJECTORY PLATFORM TARGETING GUIDES: "IN OUR OR THE OTHER DAY, DESPITE HAVING DONE MANY OF THESE CASES, THE WRONG NUMBER WAS READ-OUT (BIOPSY DEPTH RATHER THAN TARGET DEPTH), RESULTING IN A PLACEMENT THAT WAS 1CM TOO DEEP. FORTUNATELY, NO INJURY RESULTED (THE TIP WAS IN A CSF SPACE), BUT THERE WAS THE REAL POSSIBILITY OF DISASTER. I WOULD RECOMMEND THAT YOU EITHER 1) REMOVE THE BIOPSY DEPTH COLUMN AND SIMPLY NOTE SEPARATELY THAT BIOPSY DEPTH IS 10MM FURTHER (SOMETHING THAT SHOULD BE OBVIOUS TO ANYONE, ANYWAY), OR ELSE 2) SIMPLY WRITE IN THAT COLUMN "+10MM". THIS ISSUE WAS DUE TO USER ERROR, THE DEPTH SHEET WAS CORRECT AND DISPLAYED AS IT WAS INTENDED TO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1224388 FHC WAYPOINT STEREOTACTIC SYSTEM STEREOTACTIC INSTRUMENT HAW FHC, INC. MP-KIT-P-ED-00598 00873263005989

    Patients

    Seq Age Sex Outcome Treatment
    1