PENTAX EC-3490LKRecalls & reported problems

Summary

The FDA's MAUDE database contains 42 adverse event reports that list this exact device (DI 04961333223695), received between Mar 1, 2022 and Nov 19, 2024 — classified as 2 injuries, 40 malfunctions.

The most frequently reported specific device problem is “Break” (8 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 42 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 19, 2024Fluid/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 20720763 ↗
• MalfunctionOct 15, 2024Optical Obstruction; Optical Obstruction

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20448325 ↗
• MalfunctionOct 10, 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 20414424 ↗
• MalfunctionOct 10, 2024No Display/Image; No Display/Image

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20414377 ↗
• MalfunctionJun 27, 2024Detachment 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 19621414 ↗
• MalfunctionMay 24, 2024Optical 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 19389291 ↗
• MalfunctionMay 13, 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 19296036 ↗
• MalfunctionApr 8, 2024Erratic or Intermittent Display; Erratic or Intermittent Display

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19057232 ↗
• MalfunctionJan 12, 2024Erratic or Intermittent Display; Erratic or Intermittent Display

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18500886 ↗
• MalfunctionJan 9, 2024Optical Obstruction; Optical Obstruction

  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 18472447 ↗
• MalfunctionNov 24, 2023Detachment 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 18203728 ↗
• MalfunctionNov 13, 2023Erratic or Intermittent Display; Erratic or Intermittent Display

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18117602 ↗
• MalfunctionSep 12, 2023No 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 17734014 ↗
• MalfunctionSep 12, 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 17727283 ↗
• MalfunctionSep 6, 2023Erratic or Intermittent Display; Erratic or Intermittent Display

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17688384 ↗
• MalfunctionAug 25, 2023Loose or Intermittent Connection; Loose or Intermittent Connection

  THE TIME OF EVENT IS NOT DURING PROCEDURE. THERE WAS NO REPORT OF PATIENT HARM. BIOPSY INLET PIECE LOOSENED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17621212 ↗
• MalfunctionAug 23, 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 17600989 ↗
• MalfunctionJun 22, 2023Erratic 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 17178754 ↗
• MalfunctionJun 8, 2023Erratic 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 17084520 ↗
• InjuryJun 6, 2023Suction Problem; Suction Problem

  PATIENT INVOLVED - NO KNOWN ADVERSE EVENT. PER THE INITIAL REPORT, AN EVENT OCCURRED DURING A PATIENT'S COLONOSCOPY PROCEDURE. THE DEVICE MALFUNCTIONED AND THERE WAS A CONCERN FOR POTENTIAL PERFORATION DUE TO THE MALFUNCTION. IN REGARD TO THIS EVENT, AND OTHERS, THE ENDOSCOPE SUCTIONS THE LUMINAL CONTENTS WITHOUT THE SUCTION BUTTON BEING PRESSED. ONCE THIS STARTS, IT TENDS TO GET WORSE. IN SOME CASES, CHANGING THE VALVE TO A NON-DISPOSABLE VALVE IMPROVED/RESOLVED THE ISSUE. THIS LEADS TO POOR AND NON-SUSTAINED INSUFFLATION OF THE INTESTINAL LUMEN, RESULTING IN POOR VISUALIZATION OF THE LUMEN. THIS IMPACTS: THE ABILITY TO IDENTIFY ABNORMALITIES, THEREFORE THE POSSIBILITY OF MISSING PATHOLOGY; RECOGNIZING LANDMARKS NECESSARY TO COMPLETE THE PROCEDURE, AND PROLONGING THE PROCEDURE OR RENDERING IT HARDER TO COMPLETE. EVENTUALLY, AND IN THE MORE SERIOUS EVENTS, SUCTION OVERCAME INSUFFLATION RESULTING IN SUCTION INTO THE MUCOSA. THIS LEADS TO EXTREME DIFFICULTY COMPLETING THE PROCEDURE, MUCOSAL INJURY THROUGH CREATION OF 'SUCTION POLYPS', AND MUCOSAL TRAUMA AS WAS DOCUMENTED. THE INABILITY TO MAINTAIN LUMINAL INSUFFLATION ALSO GIVES RISE TO THE SUSPICION OF PERFORATION, WHICH THEN HAS RA

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17068703 ↗
• InjuryJun 5, 2023Suction Problem; Suction Problem

  PATIENT INVOLVED - NO KNOWN ADVERSE EVENT. PER THE INITIAL REPORT, AN EVENT OCCURRED DURING A PATIENT'S COLONOSCOPY PROCEDURE. THE DEVICE MALFUNCTIONED AND THERE WAS A CONCERN FOR POTENTIAL PERFORATION DUE TO THE MALFUNCTION. IN REGARD TO THIS EVENT, AND OTHERS, THE ENDOSCOPE SUCTIONS THE LUMINAL CONTENTS WITHOUT THE SUCTION BUTTON BEING PRESSED. ONCE THIS STARTS, IT TENDS TO GET WORSE. IN SOME CASES, CHANGING THE VALVE TO A NON-DISPOSABLE VALVE IMPROVED/RESOLVED THE ISSUE. THIS LEADS TO POOR AND NON-SUSTAINED INSUFFLATION OF THE INTESTINAL LUMEN, RESULTING IN POOR VISUALIZATION OF THE LUMEN. THIS IMPACTS:(1) THE ABILITY TO IDENTIFY ABNORMALITIES, THEREFORE THE POSSIBILITY OF MISSING PATHOLOGY; (2) RECOGNIZING LANDMARKS NECESSARY TO COMPLETE THE PROCEDURE, AND (3) PROLONGING THE PROCEDURE OR RENDERING IT HARDER TO COMPLETE. EVENTUALLY, AND IN THE MORE SERIOUS EVENTS, SUCTION OVERCAME INSUFFLATION RESULTING IN SUCTION INTO THE MUCOSA. THIS LEADS TO EXTREME DIFFICULTY COMPLETING THE PROCEDURE, MUCOSAL INJURY THROUGH CREATION OF 'SUCTION POLYPS', AND MUCOSAL TRAUMA AS WAS DOCUMENTED. THE INABILITY TO MAINTAIN LUMINAL INSUFFLATION ALSO GIVES RISE TO THE SUSPICION OF PERFORATION, WHICH

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17058165 ↗
• MalfunctionMay 30, 2023Erratic 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 17028371 ↗
• MalfunctionFeb 21, 2023Detachment 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 16406714 ↗
• MalfunctionFeb 21, 2023Break; 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 16406712 ↗
• MalfunctionFeb 21, 2023Break; 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 16406700 ↗

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