BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LACRIMAL TUBE

    MDR report key: 13590702 · Received February 24, 2022

    Report

    Report Number
    13590702
    Event Type
    Malfunction
    Date Received
    February 24, 2022
    Date of Event
    October 5, 2021
    Report Date
    February 16, 2022
    Manufacturer
    FCI S A S FCI 20 22
    Product Code
    OKS
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    PATIENT SCHEDULED FOR OUTPATIENT SURGERY (BILATERAL PROBING OF LACRIMAL DUCTS WITH POSSIBLE TUBE INSERTION). WHEN INSERTING THE TUBE IN THE RIGHT LACRIMAL DUCT, THE GUIDING PORTION OF THE TUBE BROKE OFF DURING THE THREADING OF THE TUBE. (VENDOR FCI REF S1.1800U SELF-THREADING MONOKA WIDE COLLARETTE LOT 1853670). SURGEON NOTIFIED SCRUB TECH AND CIRCULATOR OF INCIDENT. SURGEON VISUALIZED SUPERFICIALLY WITH A SINUSCOPE TO SEE IF HE COULD FIND THE BROKEN PORTION. WHEN HE WAS UNABLE TO, HE CONTACTED ENT (EAR, NOSE AND THROAT). ENT ARRIVED AND PERFORMED A BILATERAL NASAL ENDOSCOPY AND DIRECT LARYNGOSCOPY/BRONCHOSCOPY AND WAS UNABLE TO LOCATE THE BROKEN PORTION. CONSULTED GI (GASTROINTESTINAL) TO SEE IF PIECE HAD MOVED TO ESOPHAGUS. GI PERFORMED AN EGD (ESOPHAGOGASTRODUODENOSCOPY), BROKEN PORTION STILL NOT FOUND. BLACK WIRE IS GUIDEWIRE, AND THIS IS A PORTION THAT BROKE OFF, THE CLEAR IS THE TUBE THAT WAS GOING TO BE INSERTED, THE METAL PIECE IS THE OR LACRIMAL PROBE. COMMENT MADE "HE BELIEVES THE LACRIMAL PROBE MIGHT HAVE CAUSED THE BREAKAGE BECAUSE HE FELT RESISTANCE WHEN HE ATTEMPTED TO RETRACT. WHEN HE RETRACTED, HE FELT IT POP AND THAT'S HOW HE KNOWS A PIECE BROKE OFF."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    66529 LACRIMAL TUBE LACRIMAL STENTS AND INTUBATION SETS OKS FCI S A S FCI 20 22 SELF-THREADING MONOKA WIDE COLLARETTE FAYET, BERNARD, RITLENG 1853670

    Patients

    Seq Age Sex Outcome Treatment
    1 365 DA Female