PENTAX Medical EG34-i10Recalls & reported problems
Hoya Corporation · PENTAX Medical Video Upper GI Scope EG34-i10 · Class 2
All models of PENTAX Medical (34)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This Pentax video gastroscope, a flexible scope used to look into the stomach and upper gut, has 106 reports, including 2 deaths and 2 injuries. Many reports describe fluid or blood leaking, blocked flow channels, breaks, and image failures, and a report describes a clip left inside the scope's channel that dropped into a patient. 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
- 104
- Deaths reported
- 2
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 104 adverse event reports that list this exact device (DI 04961333245888), received between Aug 5, 2021 and Feb 17, 2026 — classified as 2 deaths, 2 injuries, 100 malfunctions.
The most frequently reported specific device problem is “Obstruction of Flow” (22 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
- Obstruction of Flow22
- Fluid/Blood Leak21
- Break20
- Erratic or Intermittent Display16
- No Display/Image9
- Optical Distortion4
- Detachment of Device or Device Component3
- Device Reprocessing Problem3
Patient problems
- No Clinical Signs, Symptoms or Conditions99
- Cardiac Arrest2
- Foreign Body In Patient2
- Respiratory Arrest2
Recent adverse event reports
The 25 most recent of 104 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 17, 2026Erratic 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 24361043 ↗MalfunctionJan 27, 2026Erratic 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 24186254 ↗InjuryDec 15, 2025Contamination /Decontamination Problem; Failure to Clean Adequately; Contamination /Decontamination Problem; Failure to Clean Adequately
ON 27-NOV-2025, PENTAX MEDICAL BECAME AWARE OF AN EVENT INVOLVING A PENTAX MEDICAL VIDEO GASTROSCOPE MODEL EG34-I10 SERIAL NUMBER (B)(6) IN CANADA WITHIN THE PAI REGION. DURING AN ENDOSCOPIC PROCEDURE, IT WAS REPORTED THAT A HEMOSTATIC CLIP USED FOR A PREVIOUS PATIENT REMAINED IN THE INSTRUMENT CHANNEL AND DROPPED INTO THE PATIENT'S BODY. THE DROPPED HEMOSTATIC CLIP WAS IDENTIFIED AS A BOSTON SCIENTIFIC RESOLUTION 360 ULTRA CLIP SIZE 2.8 MM. THE DROPPED HEMOSTATIC CLIP WAS RETRIEVED FROM THE PATIENT'S BODY. THERE WAS NO REPORT OF PATIENT HARM. THIS EVENT MEETS THE REQUIREMENTS FOR FDA REPORTABILITY. HOWEVER, SUBMISSION OF THIS REPORT DOES NOT CONSTITUTE AN ADMISSION THAT MEDICAL PERSONNEL, USER FACILITY, IMPORTER, MANUFACTURER, OR PRODUCT CAUSED OR CONTRIBUTED TO THE EVENT.
Patient problems: Foreign Body In Patient
MAUDE report 23812397 ↗InjuryDec 15, 2025Contamination /Decontamination Problem; Failure to Clean Adequately; Contamination /Decontamination Problem; Failure to Clean Adequately
MalfunctionNov 10, 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 23507591 ↗DeathApr 9, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
ON 02-APR-2025, PENTAX MEDICAL BECAME AWARE OF A PATIENT DEATH INVOLVING A PENTAX MEDICAL VIDEO GASTROSCOPE, MODEL EG34-I10, SERIAL NUMBER (B)(6). ACCORDING TO THE INITIAL REPORT, THE PHYSICIAN PERFORMED A THERAPEUTIC ENDOSCOPY TO IDENTIFY A GASTROINTESTINAL (GI) BLEEDING SOURCE. THE BLEEDING SOURCE WAS FOUND, HEMOSTASIS WAS ACHIEVED USING ELECTROCOAGULATION, AND CLIPS WERE DEPLOYED TO PREVENT FURTHER BLEEDING. DURING THE PROCEDURE, THE PATIENT'S PHYSICAL CONDITION DETERIORATED. THE ENDOSCOPE WAS REMOVED, CARDIOPULMONARY RESUSCITATION (CPR) WAS PERFORMED, AND A CODE BLUE TEAM WAS ACTIVATED. THE PATIENT WAS PRONOUNCED DEAD ON THE SAME DAY, (B)(6) 2025. THE PENTAX MEDICAL VIDEO GASTROSCOPE REPORTEDLY FUNCTIONED NORMALLY DURING THE PROCEDURE. THERE WAS NO INDICATION OF DEVICE MALFUNCTION, AND THE DEATH WAS NOT ATTRIBUTED TO THE ENDOSCOPE. THE PROCEDURE WAS SCHEDULED IN ADVANCE AND WAS NOT AN EMERGENCY CASE. THE PATIENT HAD A HISTORY OF HEART SURGERY; HOWEVER, DETAILED MEDICAL HISTORY WAS NOT AVAILABLE. THIS EVENT MEETS THE REQUIREMENTS FOR FDA REPORTABILITY; HOWEVER, SUBMISSION OF THIS REPORT DOES NOT CONSTITUTE AN ADMISSION THAT MEDICAL PERSONNEL, USER FACILITY, IMPORTER, MANUFACTURE
Patient problems: Cardiac Arrest; Respiratory Arrest
MAUDE report 21810952 ↗DeathApr 9, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
ON 02-APR-2025, PENTAX MEDICAL BECAME AWARE OF A PATIENT DEATH INVOLVING A PENTAX MEDICAL VIDEO GASTROSCOPE, MODEL EG34-I10, SERIAL NUMBER (B)(6) ACCORDING TO THE INITIAL REPORT, THE PHYSICIAN PERFORMED A THERAPEUTIC ENDOSCOPY TO IDENTIFY A GASTROINTESTINAL (GI) BLEEDING SOURCE. THE BLEEDING SOURCE WAS FOUND, HEMOSTASIS WAS ACHIEVED USING ELECTROCOAGULATION, AND CLIPS WERE DEPLOYED TO PREVENT FURTHER BLEEDING. DURING THE PROCEDURE, THE PATIENT'S PHYSICAL CONDITION DETERIORATED. THE ENDOSCOPE WAS REMOVED, CARDIOPULMONARY RESUSCITATION (CPR) WAS PERFORMED, AND A CODE BLUE TEAM WAS ACTIVATED. THE PATIENT WAS PRONOUNCED DEAD ON THE SAME DAY, (B)(6) 2025. THE PENTAX MEDICAL VIDEO GASTROSCOPE REPORTEDLY FUNCTIONED NORMALLY DURING THE PROCEDURE. THERE WAS NO INDICATION OF DEVICE MALFUNCTION, AND THE DEATH WAS NOT ATTRIBUTED TO THE ENDOSCOPE. THE PROCEDURE WAS SCHEDULED IN ADVANCE AND WAS NOT AN EMERGENCY CASE. THE PATIENT HAD A HISTORY OF HEART SURGERY; HOWEVER, DETAILED MEDICAL HISTORY WAS NOT AVAILABLE. THIS EVENT MEETS THE REQUIREMENTS FOR FDA REPORTABILITY; HOWEVER, SUBMISSION OF THIS REPORT DOES NOT CONSTITUTE AN ADMISSION THAT MEDICAL PERSONNEL, USER FACILITY, IMPORTER, MANUFACTURER
Patient problems: Cardiac Arrest; Respiratory Arrest
MAUDE report 21806227 ↗MalfunctionSep 19, 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 20254404 ↗MalfunctionAug 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 20000022 ↗MalfunctionJul 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.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19748033 ↗MalfunctionJul 4, 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 19673044 ↗MalfunctionJul 1, 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 19641326 ↗MalfunctionJun 27, 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 19621420 ↗MalfunctionJun 26, 2024Obstruction 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 19612625 ↗MalfunctionJun 24, 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 19592265 ↗MalfunctionJun 13, 2024Erratic or Intermittent Display; Erratic or Intermittent Display
HOLD FOR CM 6/26THE 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 19526123 ↗MalfunctionJun 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 19507899 ↗MalfunctionJun 4, 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 19456508 ↗MalfunctionMay 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 19328235 ↗MalfunctionMay 14, 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 19307432 ↗MalfunctionMay 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 19275134 ↗MalfunctionMay 7, 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 19256738 ↗MalfunctionMar 29, 2024Obstruction 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 19001654 ↗MalfunctionMar 28, 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 18993662 ↗MalfunctionMar 21, 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 18947560 ↗
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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.
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