MalfunctionKNQ

BOUGIECAP

Received Jan 22, 2026 · Event occurred Dec 17, 2025

Report 24150107 · MDR key 24150107

Device

Generic name

Dilator, Esophageal

Manufacturer

Ovesco Endoscopy Usa Inc.

Model number

17/18

Catalog number

400.32.04

Lot number

861065

Patient

56 YR · Male

No Clinical Signs, Symptoms or Conditions

Narrative

Description of Event or Problem

THE BOUGIE CAP WAS PLACED ON THE SCOPE AND FOLLOWING THE IFU [INSTRUCTIONS FOR USE] PLACING THE PROVIDED ADHESIVE TAPE. THIS TAPE IS CLEAR AND COMPLETELY COLORLESS, POSES DIFFICULTY SEEING POST PROCEDURE FOR REMOVAL. TAPE IS SINGLE USE AND MEANT FOR REMOVAL AFTER PATIENT USE. NOT INTENDED FOR REPROCESSING.