BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TANGENT SINGLE USE DIGITAL CATHETER

    MDR report key: 24775792 · Received April 3, 2026

    Report

    Report Number
    24775792
    Event Type
    Malfunction
    Date Received
    April 3, 2026
    Date of Event
    February 25, 2026
    Report Date
    March 30, 2026
    Manufacturer
    TANGENT ENDOSCOPY, LLC
    Product Code
    FBN
    UDI-DI
    00850061601018
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NV
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    DURING THE TANGENT ENDOSCOPY PORTION OF THE PROCEDURE TO EXPLORE THE COMMON BILE DUCT AND GALLSTONE REMOVAL, THE STAFF OBSERVED THAT THE TIP OF THE TANGENT ENDOSCOPY SCOPE WAS BROKEN UPON EXTRACTION FROM THE DUCT. UPON INSPECTION THE TIP OF THE SCOPE WAS BROKEN AND SMALL PIECE OR PIECES WERE MISSING AND FOUND IN THE PATIENT ABDOMINAL CAVITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    839064 TANGENT SINGLE USE DIGITAL CATHETER CHOLEDOCHOSCOPE AND ACCESSORIES, FLEXIBLE/RIGID FBN TANGENT ENDOSCOPY, LLC (10)2601944 00850061601018

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Male Other