inforMED
MalfunctionFBO

N.A.

Received Sep 15, 2025 · Event occurred Aug 5, 2025

Report 23051014 · MDR key 23051014

Device

Generic name

Cystourethroscope

Model number

27040XB

Catalog number

27040XB

Lot number

U002

Product problems

  • Break

Patient

82 YR · Male

  • No Clinical Signs, Symptoms or Conditions
  • No Clinical Signs, Symptoms or Conditions

Narrative

Description of Event or Problem

WHILE THE SURGEON WAS USING THE RESECTOSCOPE, THE 28 FR SHEATH WITH CERAMIC BEAK BROKE. THE CERAMIC BEAK BROKE IN SEVERAL PIECES INSIDE THE PATIENT. THE SURGEON WAS ABLE TO RETRIEVE ALL PIECES WITHOUT INCIDENT. THE SURGEON WAS ABLE TO GET A BACK-UP TO FINISH THE PROCEDURE. MANUFACTURER RESPONSE FOR CYSTOURETHROSCOPE, N.A. (PER SITE REPORTER). THEY ARE STARTING INVESTIGATION AND SENT A LABEL FOR ITEM TO BE RETURNED.