BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CHECKPOINT GUARDIAN

    MDR report key: 22530378 · Received July 17, 2025

    Report

    Report Number
    22530378
    Event Type
    Malfunction
    Date Received
    July 17, 2025
    Date of Event
    May 30, 2025
    Report Date
    June 27, 2025
    Manufacturer
    CHECKPOINT SURGICAL, INC.
    Product Code
    ETN
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    TX
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 0

    CHECKPOINT SURGICAL GUARDIAN NERVE STIMULATOR REF(B)(4) LOT:10360083 EXP: 2026-12-01. DURING USE THE LIGHT TURNED RED AND "ERR" DISPLAYED ON SCREEN. UNABLE TO RESET OR USE PRODUCT. CHARGE NURSE NOTIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    839760 CHECKPOINT GUARDIAN STIMULATOR, NERVE ETN CHECKPOINT SURGICAL, INC. 9095 10360083

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Female