PENTAX FG-29VRecalls & reported problems
Hoya Corporation · GASTRO FIBERSCOPE FG-29V · Class 2
All models of PENTAX (72)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 20
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 04961333228584), received between Feb 15, 2022 and Jul 12, 2024 — classified as 20 malfunctions.
The most frequently reported specific device problem is “Break” (11 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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Break11
- Fluid/Blood Leak7
- Obstruction of Flow2
Patient problems
- No Clinical Signs, Symptoms or Conditions20
Recent adverse event reports
The 20 most recent of 20 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 12, 2024Fluid/Blood Leak; Fluid/Blood Leak
THE TIME OF EVENT IS NOT DURING PROCEDURE. THERE WAS NO REPORT OF PATIENT HARM. FIBER IMAGE FAILURE (FLUID DAMAGE).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19727715 ↗MalfunctionJul 1, 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 19641431 ↗MalfunctionMay 24, 2024Fluid/Blood Leak; Fluid/Blood Leak
THE TIME OF EVENT IS NOT DURING PROCEDURE. THERE WAS NO REPORT OF PATIENT HARM. FIBER IMAGE FAILURE(FLUID DAMAGE).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19389294 ↗MalfunctionMar 28, 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 18995792 ↗MalfunctionAug 29, 2023Break; Break
THE TIME OF EVENT IS NOT DURING PROCEDURE. THERE WAS NO REPORT OF PATIENT HARM. FIBER IMAGE FAILURE(BROKEN).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17639741 ↗MalfunctionAug 3, 2023Break; Break
THE TIME OF EVENT IS NOT DURING PROCEDURE. THERE WAS NO REPORT OF PATIENT HARM. VIDEO IMAGE FAILURE(OBJECTIVE LENS BROKEN).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17448050 ↗MalfunctionJul 6, 2023Break; Break
THE TIME OF EVENT IS NOT DURING PROCEDURE. THERE WAS NO REPORT OF PATIENT HARM. FIBER IMAGE FAILURE (BROKEN).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17263812 ↗MalfunctionFeb 20, 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 16402291 ↗MalfunctionFeb 12, 2023Fluid/Blood Leak; Fluid/Blood Leak
THE TIME OF EVENT IS UNKNOWN. THERE WAS NO REPORT OF PATIENT HARM. FIBER IMAGE FAILURE(FLUID DAMAGE).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16359968 ↗MalfunctionJan 11, 2023Fluid/Blood Leak; Fluid/Blood Leak
THE TIME OF EVENT IS UNKNOWN.THERE WAS NO REPORT OF PATIENT HARM.FIBER IMAGE FAILURE(FLUID DAMAGE).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16136091 ↗MalfunctionDec 22, 2022Fluid/Blood Leak; Fluid/Blood Leak
THE TIME OF EVENT IS UNKNOWN. THERE WAS NO REPORT OF PATIENT HARM. FIBER IMAGE FAILURE(FLUID DAMAGE).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16031929 ↗MalfunctionNov 7, 2022Break; Break
THE TIME OF EVENT IS UNKNOWN. THERE WAS NO REPORT OF PATIENT HARM. VIDEO IMAGE FAILURE(OBJECTIVE LENS BROKEN.)
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15749963 ↗MalfunctionOct 24, 2022Fluid/Blood Leak; Fluid/Blood Leak
THE TIME OF EVENT IS UNKNOWN. THERE WAS NO REPORT OF PATIENT HARM. FIBER IMAGE FAILURE(FLUID DAMAGE).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15664553 ↗MalfunctionJul 20, 2022Break; Break
THE TIME OF EVENT IS UNKNOWN. THERE WAS NO REPORT OF PATIENT HARM. VIDEO IMAGE FAILURE(OBJECTIVE LENS BROKEN).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15062630 ↗MalfunctionJun 13, 2022Break; 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 14673052 ↗MalfunctionMay 23, 2022Fluid/Blood Leak; Fluid/Blood Leak
THE TIME OF EVENT IS UNKNOWN. THERE WAS NO REPORT OF PATIENT HARM. FIBER IMAGE FAILURE(FLUID DAMAGE).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14467797 ↗MalfunctionApr 26, 2022Break; Break
THE TIME OF EVENT IS UNKNOWN. THERE WAS NO REPORT OF PATIENT HARM. VIDEO IMAGE FAILURE(OBJECTIVE LENS BROKEN).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14199911 ↗MalfunctionApr 26, 2022Break; Break
THE TIME OF EVENT IS UNKNOWN. THERE WAS NO REPORT OF PATIENT HARM. VIDEO IMAGE FAILURE(OBJECTIVE LENS BROKEN).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14199907 ↗MalfunctionApr 12, 2022Break; 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 14080660 ↗MalfunctionFeb 15, 2022Break; Break
THE TIME OF EVENT IS UNKNOWN. THERE WAS NO REPORT OF PATIENT HARM. VIDEO IMAGE FAILURE (OBJECTIVE LENS BROKEN).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13531032 ↗
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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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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