RHINO-LARYNGOFIBERSCOPE OLYMPUS ENF TYPE XP (REF N4447140)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04953170458293), received between Nov 21, 2025 and Dec 30, 2025 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (1 report).

1 other recall cover devices cleared under the same FDA submission (K221660); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 30, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE RHINO LARYNGOFIBERSCOPE HAD A MISSING LIGHT GUIDE COVER GLASS. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23921937 ↗
• MalfunctionNov 21, 2025Device Reprocessing Problem; Device Reprocessing Problem

  NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23617089 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K221660. One submission often covers many models, so check the product and lot details in each record.

• Z-0688-2024 · Dec 4, 2023 · Open, Classified
  Model No. ENF-XP, RHINO-LARYNGOFIBERSCOPE