PENTAX ES-3870KRecalls & reported problems
Hoya Corporation · VIDEO SIGMOIDOSCOPE ES-3870K SET · Class 2
All models of PENTAX (72)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 6
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 04961333228164), received between May 10, 2022 and Jan 7, 2026 — classified as 6 malfunctions.
The most frequently reported specific device problem is “Fluid/Blood Leak” (2 reports).
1 other recall cover devices cleared under the same FDA submission (K951577); 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.
Reports received per month
Most reported problems
Device problems
- Fluid/Blood Leak2
- Break1
- Detachment of Device or Device Component1
- Erratic or Intermittent Display1
- Optical Distortion1
Patient problems
- No Clinical Signs, Symptoms or Conditions6
Recent adverse event reports
The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 7, 2026Fluid/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 23986807 ↗MalfunctionJan 28, 2025Fluid/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 21249809 ↗MalfunctionOct 15, 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 20448312 ↗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 20167205 ↗MalfunctionJul 21, 2022Optical Distortion; Optical Distortion
THE TIME OF EVENT IS UNKNOWN. THERE WAS NO REPORT OF PATIENT HARM. VIDEO IMAGE FAILURE(CLOUDY).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15071450 ↗MalfunctionMay 10, 2022Break; Break
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 14343308 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K951577. One submission often covers many models, so check the product and lot details in each record.
- Z-2075-2016 · Apr 6, 2016 · TerminatedSignmoidoscope Intended to provide optical visualization of, therapeutic access to, the Lower Gastrointestinal Tract. This anatomy includes, but is not restricted to, the organs, t
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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