PENTAX EG-2990i (UDI 04961333228478)Recalls & reported problems
Hoya Corporation · VIDEO UPPER G.I.SCOPE EG-2990i · Class 2
Quick summary
This Pentax video gastroscope is a flexible scope used to look inside the upper digestive tract. Many reports describe parts breaking or coming loose, fluid leaks, and video image failures. The 156 reports include no deaths and 1 injury. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 156
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 156 adverse event reports that list this exact device (DI 04961333228478), received between Sep 10, 2021 and Mar 12, 2024 — classified as 1 injury, 155 malfunctions.
The most frequently reported specific device problem is “Break” (45 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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Break45
- Detachment of Device or Device Component30
- Fluid/Blood Leak29
- Obstruction of Flow17
- Erratic or Intermittent Display11
- No Display/Image8
- Optical Obstruction5
- Loose or Intermittent Connection4
Patient problems
- No Clinical Signs, Symptoms or Conditions154
- Foreign Body In Patient1
- Insufficient Information1
Recent adverse event reports
The 25 most recent of 156 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 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 18883536 ↗MalfunctionMar 12, 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 18883523 ↗MalfunctionMar 12, 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 18883516 ↗MalfunctionMar 12, 2024Erratic or Intermittent Display; Erratic or Intermittent Display
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 18883300 ↗MalfunctionMar 12, 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 18883287 ↗MalfunctionMar 1, 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 18813816 ↗MalfunctionFeb 29, 2024Loose 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 18804860 ↗MalfunctionFeb 28, 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 18794773 ↗MalfunctionFeb 28, 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 18794765 ↗MalfunctionFeb 21, 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 18745020 ↗MalfunctionFeb 21, 2024Obstruction of Flow; Obstruction of Flow
THE TIME OF EVENT IS NOT DURING PROCEDURE. THERE WAS NO REPORT OF PATIENT HARM. OPERATION/SUCTION CHANNEL CLOGGED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18744978 ↗MalfunctionFeb 20, 2024Erratic or Intermittent Display; Erratic or Intermittent Display
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 18736271 ↗MalfunctionFeb 20, 2024Optical Obstruction; Optical Obstruction
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 18736260 ↗MalfunctionFeb 19, 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 18728743 ↗MalfunctionFeb 16, 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(FLUID DAMAGE).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18718487 ↗MalfunctionFeb 16, 2024Fluid/Blood Leak; Fluid/Blood Leak
THE TIME OF EVENT IS NOT DURING PROCEDURE. THERE WAS NO REPORT OF PATIENT HARM. VIDEO IMAGE FAILURE(FLUID DAMAGE).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18718456 ↗MalfunctionFeb 15, 2024Obstruction 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 18708833 ↗MalfunctionFeb 15, 2024No Display/Image; No Display/Image
THE TIME OF EVENT IS NOT DURING PROCEDURE. THERE WAS NO REPORT OF PATIENT HARM. VIDEO IMAGE FAILURE(BLACKOUT ).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18708620 ↗MalfunctionFeb 14, 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 18700716 ↗MalfunctionFeb 14, 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 18700707 ↗MalfunctionFeb 13, 2024Optical Obstruction; Optical Obstruction
THE TIME OF EVENT IS NOT DURING PROCEDURE. THERE WAS NO REPORT OF PATIENT HARM. VIDEO IMAGE FAILURE(SHADOW IN IMAGE).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18692760 ↗MalfunctionFeb 9, 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 18673884 ↗MalfunctionFeb 9, 2024Fluid/Blood Leak; Fluid/Blood Leak
THE TIME OF EVENT IS NOT DURING PROCEDURE. THERE WAS NO REPORT OF PATIENT HARM. VIDEO IMAGE FAILURE(FLUID DAMAGE)
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18673796 ↗MalfunctionFeb 7, 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 18656361 ↗MalfunctionFeb 5, 2024Obstruction of Flow; Obstruction of Flow
THE TIME OF EVENT IS NOT DURING PROCEDURE. THERE WAS NO REPORT OF PATIENT HARM. OPERATION/SUCTION CHANNEL CLOGGED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18637869 ↗
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 · TerminatedPentax 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 · TerminatedGastroscope 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
Other Gastroscope and accessories, flexible/rigid devices
- PENTAX Medical EG29-i10cHoya Corporation · Gastroscope And Accessories, Flexible/Rigid1,623 reports
- EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE OLYMPUS GIF-1TH190Olympus Medical Systems Corp. · Gastroscope And Accessories, Flexible/Rigid4 recalls6 deaths1,025 reports
- EVIS EXERA lll GASTROINTESTINAL VIDEOSCOPE OLYMPUS GIF-XP190NOlympus Medical Systems Corp. · Gastroscope and accessories, flexible/rigid1 recall559 reports
- EVIS EXERA II GASTROINTESTINAL VIDEOSCOPE GIF-Q165Olympus Medical Systems Corp. · Gastroscope and accessories, flexible/rigid349 reports
- EVIS EXERA II GASTROINTESTINAL VIDEOSCOPE OLYMPUS GIF TYPE H180Olympus Medical Systems Corp. · Gastroscope and accessories, flexible/rigid1 death302 reports
- PENTAX EG27-i10Hoya Corporation · Gastroscope and accessories, flexible/rigid261 reports
- EVIS EXERA II COLONOVIDEOSCOPE OLYMPUS CF TYPE H180ALOlympus Medical Systems Corp. · Gastroscope and accessories, flexible/rigid2 deaths252 reports
- BALLOON MAJ-1351Olympus Medical Systems Corp. · Gastroscope and accessories, flexible/rigid174 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.