PENTAX EG-3490KRecalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 04961333227044), received between Jan 7, 2021 and Jan 16, 2025 — classified as 10 malfunctions.

The most frequently reported specific device problem is “Break” (3 reports).

2 other recalls cover devices cleared under the same FDA submission (K131902); 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 16, 2025Detachment 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 21165050 ↗
• MalfunctionSep 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 20178326 ↗
• MalfunctionSep 10, 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 20178231 ↗
• MalfunctionMay 1, 2023Material Split, Cut or Torn; Material Split, Cut or Torn

  THE TIME OF EVENT IS UNKNOWN. THERE WAS NO REPORT OF PATIENT HARM. INSERTION FLEXIBLE TUBE (IFT) STEEL BRAID PIERCING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16841921 ↗
• MalfunctionJan 12, 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 16143595 ↗
• MalfunctionNov 14, 2022Fluid/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 15786683 ↗
• MalfunctionNov 1, 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 15705615 ↗
• MalfunctionOct 20, 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 15636877 ↗
• MalfunctionOct 14, 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 15603118 ↗
• MalfunctionJan 7, 2021Partial Blockage; Break; Failure to Disconnect; Device Damaged by Another Device; Partial Blockage; Break; Failure to Disconnect; Device Damaged by Another Device

  PENTAX MEDICAL WAS MADE AWARE OF A COMPLAINT ON 08-DEC-2020 UNDER RMA NOTIFICATION (B)(4) FOR AN "ACCESSORY STUCK IN SCOPE" INVOLVING THE PENTAX MEDICAL VIDEO GASTROSCOPE, MODEL EG-3490K, SERIAL NUMBER (B)(4). THE USER ALSO REPORTED THE STENT HAD BROKEN OFF. THE USER FACILITY RESPONDED TO A GFE REQUEST VIA EMAIL ON 15-DEC-2020 AND AGAIN ON 23-DEC-2020, AND STATED THE ENDOSCOPE WAS BEING USED FOR TREATMENT. A BOSTON SCIENTIFIC PANCREATIC PIGTAIL STENT AND WAS TAKEN OUT BY A ENDOCHOICE RAT TOOTH GRASPER. NO SERIOUS INJURY OR DEATH OF A PATIENT OR USER WAS REPORTED. THE ENDOSCOPE WAS REMOVED FROM CIRCULATION IMMEDIATELY AFTER THE FAILURE/EVENT OCCURRED AND SUBSEQUENTLY CALLED IN FOR SERVICE/REPLACEMENT THE CUSTOMER OWNED ENDOSCOPE WAS RECEIVED BY PENTAX MEDICAL FOR EVALUATION ON 16-DEC-2020. DURING EVALUATION OF THE ENDOSCOPE UNDER SERVICE ORDER (B)(4), THE PENTAX MEDICAL SERVICE REPAIR TECHNICIAN FOUND AN "ACCESSORY STUCK IN PRIMARY OPERATION CHANNEL" CONFIRMING THE CUSTOMER'S COMPLAINT AND DOCUMENTING THE FOLLOWING ADDITIONAL FINDINGS ON 21-DEC-2020: PRIMARY OPERATION CHANNEL BLOCKED, PASSED DRY LEAK TEST, PASSED WET LEAK TEST, DISTAL BODY CHIP AT CHANNEL OPENING AT THINNEST PART, U

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11135699 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K131902. One submission often covers many models, so check the product and lot details in each record.

• Z-0318-2017 · Aug 15, 2016 · Terminated
  Pentax Video Gastroscope is intended to be used with a Pentax video processor (including light source), documentation equipment, monitor, EndoTherapy Device such as a Biopsy Forcep
• Z-2071-2016 · Apr 6, 2016 · Terminated
  Gastroscope Intended to provide optical visualization of and therapeutic access to the Upper Gastrointestinal Tract. This anatomy includes, but is not restricted to, the organs, ti