PENTAX EB-1990iRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04961333223206), received between Feb 28, 2023 and Oct 9, 2023 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Obstruction of Flow” (1 report).

6 other recalls cover devices cleared under the same FDA submission (K131028); 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. How this data works · Data updated Oct 13, 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.

• MalfunctionOct 9, 2023Optical Obstruction; Optical Obstruction

  THE TIME OF EVENT IS NOT DURING PROCEDURE. THERE WAS NO REPORT OF PATIENT HARM. VIDEO IMAGE FAILURE(CLOUDY).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17902226 ↗
• MalfunctionFeb 28, 2023Obstruction of Flow; Obstruction of Flow

  THE TIME OF EVENT IS UNKNOWN. THERE WAS NO REPORT OF PATIENT HARM. OPERATION/SUCTION CHANNEL CLOGGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16451085 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K131028. One submission often covers many models, so check the product and lot details in each record.

• Z-2875-2016 · May 31, 2016 · Terminated
  Pentax Video Bronchoscope Designed to be used with a Pentax Video Processor (including light source), documentation equipment, video monitor, endo-therapy accessories (such as bio
• Z-2065-2016 · Apr 6, 2016 · Terminated
  Bronchoscope Intended to provide optical visualization of and therapeutic access to the Airway and Bronchial Tree. This anatomy includes, but is not restricted to, the organs, tiss
• Z-2076-2016 · Apr 6, 2016 · Terminated
  Ultrasound Bronchoscope Intended to provide optical visualization of, ultrasonic visualization of and therapeutic access to, the Pulmonary Tract including but not restricted to org
• Z-2325-2017 · Jan 11, 2011 · Terminated
  Video Cytoscopes
• Z-2326-2017 · Jan 11, 2011 · Terminated
  Video Naso pharyngo Laryngoscopes
• Z-2324-2017 · Jan 11, 2011 · Terminated
  Video Bronchoscope