PENTAX EC-3890LZiRecalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 04961333222827), received between Oct 18, 2021 and Apr 23, 2024 — classified as 14 malfunctions.

The most frequently reported specific device problem is “Break” (6 reports).

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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 23, 2024Erratic or Intermittent Display; Erratic or Intermittent Display

  THE TIME OF EVENT IS UNKNOWN. THERE WAS NO REPORT OF PATIENT HARM. VIDEO IMAGE FAILURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19161269 ↗
• MalfunctionJan 16, 2024No Display/Image; No Display/Image

  THE TIME OF EVENT IS UNKNOWN. THERE WAS NO REPORT OF PATIENT HARM. VIDEO IMAGE FAILURE(BLACKOUT ).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18515750 ↗
• MalfunctionFeb 27, 2023Unintended Movement; Unintended Movement

  THE TIME OF EVENT IS UNKNOWN. THERE WAS NO REPORT OF PATIENT HARM. VIDEO IMAGE FAILURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16441638 ↗
• MalfunctionFeb 20, 2023Fluid/Blood Leak; Fluid/Blood Leak

  THE TIME OF EVENT IS UNKNOWN. THERE WAS NO REPORT OF PATIENT HARM. VIDEO IMAGE FAILURE(FLUID DAMAGE)

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16403089 ↗
• MalfunctionNov 21, 2022Break; Break

  THE TIME OF EVENT IS UNKNOWN. THERE WAS NO REPORT OF PATIENT HARM. VIDEO IMAGE FAILURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15832081 ↗
• MalfunctionOct 6, 2022Break; Break

  THE TIME OF EVENT IS UNKNOWN. THERE WAS NO REPORT OF PATIENT HARM. VIDEO IMAGE FAILURE (BLACKOUT).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15548255 ↗
• MalfunctionSep 21, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  THE TIME OF EVENT IS UNKNOWN. THERE WAS NO REPORT OF PATIENT HARM. AIR/WATER NOZZLE PEELED OFF (BLACK GLUE).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15460329 ↗
• MalfunctionJul 15, 2022Break; Break

  THE TIME OF EVENT IS UNKNOWN. THERE WAS NO REPORT OF PATIENT HARM. VIDEO IMAGE FAILURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15025278 ↗
• MalfunctionApr 13, 2022Break; Break

  THE TIME OF EVENT IS UNKNOWN. THERE WAS NO REPORT OF PATIENT HARM. VIDEO IMAGE FAILURE(BLACKOUT ).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14098933 ↗
• MalfunctionApr 4, 2022Break; Break

  THE TIME OF EVENT IS UNKNOWN. THERE WAS NO REPORT OF PATIENT HARM. VIDEO IMAGE FAILURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13992832 ↗
• MalfunctionFeb 21, 2022Obstruction of Flow; Obstruction of Flow

  THE TIME OF EVENT IS UNKNOWN. THERE WAS NO REPORT OF PATIENT HARM. AIR/WATER TUBE CLOGGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13566472 ↗
• MalfunctionFeb 7, 2022Break; Break

  THE TIME OF EVENT IS UNKNOWN. THERE WAS NO REPORT OF PATIENT HARM. VIDEO IMAGE FAILURE(BLACKOUT).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13468740 ↗
• MalfunctionJan 18, 2022Fluid/Blood Leak; Fluid/Blood Leak

  THE TIME OF EVENT IS UNKNOWN. THERE WAS NO REPORT OF PATIENT HARM. FIBER IMAGE FAILURE(FLUID DAMAGE).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13274163 ↗
• MalfunctionOct 18, 2021Unintended Movement; Unintended Movement

  THE TIME OF EVENT IS UNKNOWN. THERE WAS NO REPORT OF PATIENT HARM. VIDEO IMAGE FAILURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12645239 ↗

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