BEUDAMED
    FDA Adverse Event Other Summary report: N

    UNITIP HIGH RESOLUTION CATHETER

    MDR report key: 17772649 · Received September 19, 2023

    Report

    Report Number
    17772649
    Event Type
    Other
    Date Received
    September 19, 2023
    Date of Event
    June 12, 2023
    Report Date
    September 15, 2023
    Manufacturer
    UNISENSOR AG
    Product Code
    FFX
    Report Source
    User Facility report
    Reporter Location
    PA
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    DURING ESOPHAGEAL MOTILITY STUDY STAFF RN WAS UNABLE TO INSERT CATHETER AND PERFORM PROCEDURE. PROBE GOT INTO ESOPHAGUS AND GAVE RESISTANCE. PROBE REMOVED AND VISIBLE BEND IN TUBE NOTICED THAT WAS THERE PRIOR TO INSERTION. SECOND PROBE WAS THEN UTILIZED FOR SUCCESSFUL PROCEDURE WITH THIS PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1891560 UNITIP HIGH RESOLUTION CATHETER SYSTEM, GASTROINTESTINAL MOTILITY (ELECTRICAL) FFX UNISENSOR AG K123245-E-1047-D

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown