PENTAX EC-3890Li (UDI 04961333248148)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 04961333248148), received between Jul 24, 2021 and Jul 27, 2021 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Contamination /Decontamination Problem” (1 report).

6 other recalls cover devices cleared under the same FDA submission (K131855); 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 27, 2021Material Split, Cut or Torn; Material Split, Cut or Torn

  THIS EVENT OCCURRED DURING REPROCESSING. THERE WAS NO REPORT OF PATIENT HARM. "AIR/WATER NOZZLE MISSING. - WATER JET CHANNEL MISSING METAL PIECE CAME OFF. THE ISSUE OCCURRED WHEN DISCONNECTING THE SCOPE FROM THE BLOCK IN THE MEDIVATORS. A RADIAL JAW WAS USED DURING THE PROCEDURE. NO MEDICAL INTERVENTION WAS NEEDED (THE ISSUE OCCURRED AFTER THE PROCEDURE)". NOT KNOWN FOR THE EXACT DATE, WE JUST KNOW THE YEAR THE COMPLAINT WAS SENT IN TO MANUFACTURER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12230346 ↗
• MalfunctionJul 27, 2021Erratic or Intermittent Display; Erratic or Intermittent Display

  THE TIME OF EVENT IS UNKNOWN. THERE WAS NO REPORT OF PATIENT HARM. POOR IMAGE QUALITY. NOT KNOWN FOR THE EXACT DATE, WE JUST KNOW THE YEAR THE COMPLAINT WAS SENT IN TO MANUFACTURER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12230323 ↗
• MalfunctionJul 24, 2021Contamination /Decontamination Problem; Contamination /Decontamination Problem

  NOT KNOWN FOR THE EXACT DATE, WE JUST KNOW THE YEAR THE COMPLAINT WAS SENT IN TO MANUFACTURER. THIS EVENT OCCURRED AT THE TIME OF REPROCESSING. THERE WAS NO REPORT OF PATIENT HARM. POTENTIAL ENDOSCOPE CONTAMINATION: CUST STATED REPROCESS TIME OUT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12222411 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K131855. One submission often covers many models, so check the product and lot details in each record.

• Z-2449-2021 · Jul 14, 2021 · Open, Classified
  Gastroscope Family # 1-Gastroscopes without a Water Jet Channel Models: EG-2790i, EG-1690K, EG-2490K, EG-2790K, EG27-i10; Gastroscope Family # 2- Gastroscopes with a Water Jet Chan
• Z-2448-2021 · Jul 14, 2021 · Open, Classified
  Colonoscope Family # 1-Pentax Video Colonoscopes (EC Family) with One Instrument Channel and a Water Jet Channel Models: EC-2990Li, EC-3490Li, EC-3890Li, EC-3490TLi, EC-3490LK, EC
• Z-1268-2020 · Jan 3, 2020 · Terminated
  Pentax Video Colonoscope Model: EC38-i10L
• Z-1267-2020 · Jan 3, 2020 · Terminated
  Pentax Video Colonoscope Model: EC34-i10L
• Z-0636-2017 · Aug 15, 2016 · Terminated
  Pentax Video Colonoscope is intended to be used with a PENTAX video processor (including light source), documentation equipment, Monitor, EndoTherapy Device such as a Biopsy Forcep
• Z-2068-2016 · Apr 6, 2016 · Terminated
  Colonoscope Intended to provide optical visualization of and therapeutic access to the Lower Gastrointestinal Tract. This anatomy includes, but is not restricted to, the organs, ti