PENTAX EG-3670URKRecalls & reported problems
Hoya Corporation · ULTRASOUND UPPER G.I.VIDEOSCOPE EG-3670URK · Class 2
All models of PENTAX (72)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This Pentax EG-3670URK upper GI video scope is used in endoscopy. The 72 reports mostly describe the scope failing mid-procedure: video images dropping out, the air/water channel clogging, fluid or blood leaking, and parts of the scope breaking. No deaths or injuries are reported, and no recalls name this device. Reports have dropped sharply, from 5 in the prior12 months to none in the most recent 12 months.
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
- 72
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 72 adverse event reports that list this exact device (DI 04961333228362), received between Nov 13, 2020 and Jan 28, 2025 — classified as 72 malfunctions.
The most frequently reported specific device problem is “Fluid/Blood Leak” (16 reports).
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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Fluid/Blood Leak16
- Break15
- Obstruction of Flow12
- No Display/Image9
- Erratic or Intermittent Display6
- Failure to Disconnect6
- Optical Obstruction5
- Optical Distortion4
Patient problems
- No Clinical Signs, Symptoms or Conditions72
- Insufficient Information6
Recent adverse event reports
The 25 most recent of 72 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 28, 2025Erratic 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 21249528 ↗MalfunctionJan 10, 2025Erratic 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 21121329 ↗MalfunctionNov 29, 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 20808432 ↗MalfunctionNov 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.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20731130 ↗MalfunctionNov 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 20680153 ↗MalfunctionOct 28, 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 20542263 ↗MalfunctionSep 9, 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 20167207 ↗MalfunctionSep 6, 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 20154291 ↗MalfunctionSep 6, 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 20154255 ↗MalfunctionSep 6, 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 20154251 ↗MalfunctionMay 2, 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 19227270 ↗MalfunctionMay 2, 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 19227251 ↗MalfunctionApr 18, 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 19131285 ↗MalfunctionMar 11, 2024Break; Break
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 18872787 ↗MalfunctionJan 30, 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. LCB DISTAL COVER GLASS MISSING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18603775 ↗MalfunctionJan 11, 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 18490440 ↗MalfunctionDec 25, 2023Optical 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 18390132 ↗MalfunctionNov 15, 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 18137184 ↗MalfunctionOct 6, 2023Obstruction of Flow; Obstruction of Flow
THE TIME OF EVENT IS UNKNOWN. THERE WAS NO REPORT OF PATIENT HARM. OPERATION/SUCTION CHANNEL CLOGGED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17883412 ↗MalfunctionSep 28, 2023Optical 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 17831637 ↗MalfunctionSep 27, 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 17822841 ↗MalfunctionSep 12, 2023Break; Break
THE TIME OF EVENT IS UNKNOWN. THERE WAS NO REPORT OF PATIENT HARM. FIBER IMAGE FAILURE(BROKEN).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17727317 ↗MalfunctionSep 12, 2023Obstruction 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 17727301 ↗MalfunctionSep 7, 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 17696519 ↗MalfunctionAug 1, 2023Obstruction of Flow; Obstruction of Flow
THE TIME OF EVENT IS NOT DURING PROCEDURE. THERE WAS NO REPORT OF PATIENT HARM. AIR/WATER TUBE CLOGGED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17431727 ↗
Other Endoscopic ultrasound system, gastroenterology-urology devices
- EVIS EXERA II ULTRASOUND GASTROVIDEOSCOPE OLYMPUS GF TYPE UCT180Olympus Medical Systems Corp. · Endoscopic ultrasound system, gastroenterology-urology5 deaths2,392 reports
- PENTAX Medical EG38-J10UTHoya Corporation · Endoscopic Ultrasound System, Gastroenterology-Urology295 reports
- EVIS EXERA II ULTRASOUND GASTROVIDEOSCOPE OLYMPUS GF TYPE UCT180Olympus Medical Systems Corp. · Endoscopic ultrasound system, gastroenterology-urology266 reports
- PENTAX EG-3870UTKHoya Corporation · Endoscopic ultrasound system, gastroenterology-urology164 reports
- PENTAX Medical EG36-J10URHoya Corporation · Endoscopic Ultrasound System, Gastroenterology-Urology126 reports
- PENTAX Medical EG34-J10UHoya Corporation · Endoscopic Ultrasound System, Gastroenterology-Urology61 reports
- BALLOON MAJ-1351Olympus Medical Systems Corp. · Endoscopic ultrasound system, gastroenterology-urology29 reports
- Acquire M00555540Boston Scientific Corporation · Endoscopic ultrasound system, gastroenterology-urology1 death18 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page