4K CAMERA HEADRecalls & reported problems across all models
Olympus Medical Systems Corp. · 3 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4,926
- Deaths reported
- 0
- Injuries reported
- 21
- Recalls
- 0
We found 3 models of 4K CAMERA HEAD by Olympus Medical Systems Corp. in the FDA's device registry (GUDID). Together they are named in 4,926 adverse event reports in the FDA's MAUDE database, received between Oct 1, 2018 and Sep 30, 2026 — classified as 21 injuries, 4,905 malfunctions.
The most frequently reported specific device problem is “No Display/Image” (2,560 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported 4K CAMERA HEAD problems
Device problems
- No Display/Image2,560
- Communication or Transmission Problem897
- Poor Quality Image662
- Connection Problem192
- Leak/Splash140
- Output Problem129
- Erratic or Intermittent Display117
- Break115
Patient problems
- No Clinical Signs, Symptoms or Conditions4,822
- No Patient Involvement57
- No Consequences Or Impact To Patient39
- Insufficient Information6
- No Known Impact Or Consequence To Patient3
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available2
4K CAMERA HEAD models
3 models, most reported first. Each model has its own page with its reports, recalls and device details.
- 4K CAMERA HEAD OLYMPUS CH-S400-XZ-EBEndoscopic video imaging system/component, gastroenterology-urology2,522 reports
- 4K CAMERA HEAD OLYMPUS CH-S400-XZ-EAEndoscopic video imaging system/component, gastroenterology-urology2,375 reports
- 4K Camera Head OLYMPUS CH-S700-XZ-EAEndoscopic Video Imaging System/Component, Gastroenterology-Urology29 reports
Recent 4K CAMERA HEAD adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 2026Gas/Air Leak; Material Split, Cut or Torn
The customer returned the autoclavable camera head for a separate issue. During the initial evaluation of the device, it was observed that failed leak test and cut in video cable observed. No patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50950406 ↗MalfunctionSep 30, 2026No Display/Image; Poor Quality Image
The customer reported that color bars were displayed on the screen during a therapeutic procedure involving an Olympus Autoclavable Camera Head. There was no patient injury reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50947861 ↗MalfunctionSep 30, 2026Poor Quality Image; Gas/Air Leak
The customer reported the camera head had dark image. During the initial evaluation of the device failed leak test was identified. There was no patient harm.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50941920 ↗MalfunctionSep 29, 2026Communication or Transmission Problem
The customer reported a communication issue during inspection for use involving an Olympus Camera Head. There was no patient injury reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50936444 ↗MalfunctionSep 29, 2026Gas/Air Leak
The customer returned the Olympus camera head for a separate issue. During the initial evaluation of the returned device, a failed leak test was observed between the cos ring and rear cover. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50936408 ↗MalfunctionSep 29, 2026Erratic or Intermittent Display; Material Split, Cut or Torn
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50926943 ↗MalfunctionSep 28, 2026Poor Quality Image; Gas/Air Leak
The customer reported poor image quality during inspection for use involving an Olympus autoclavable camera head. During the initial evaluation of the returned device, a failed leak test was observed. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50917289 ↗MalfunctionSep 28, 2026No Device Output
The customer reported that no functions were available during inspection for use involving an Olympus autoclavable camera head. There was no patient injury reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50916466 ↗MalfunctionSep 28, 2026Poor Quality Image; Communication or Transmission Problem
The customer reported that the camera head picture was not clear during reprocessing. During the initial evaluation of the device, a camera head communication error (E224) was observed. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50916322 ↗MalfunctionSep 25, 2026No Display/Image
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50905980 ↗MalfunctionSep 25, 2026No Display/Image
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50899956 ↗MalfunctionSep 24, 2026No Display/Image; Leak/Splash
The customer reported that the Olympus camera head had no image during inspection for use. During the initial evaluation of the device, it was observed that the device failed the leak test. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50884392 ↗MalfunctionSep 22, 2026No Display/Image
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50861669 ↗MalfunctionSep 22, 2026No Display/Image; Communication or Transmission Problem
The customer reported the camera head cannot see and focus image during a Robotic Laparoscopic Cholesectomic procedure. The procedure was completed using a similar device. During the initial evaluation of the device it was observed that communication error E224 occurred. There was no patient injury reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50855176 ↗MalfunctionSep 21, 2026Loose or Intermittent Connection; Gas/Air Leak
The customer returned the camera head to the service center for a separate issue. During the initial evaluation of the returned device, water tightness was lost, and the coupler came off from the scope. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50842972 ↗
Other Olympus Medical Systems Corp. products
- EVIS EXERA lll COLONOVIDEOSCOPE16 models · 15,013 reports · 7 recalls
- EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE7 models · 13,448 reports · 7 recalls
- EVIS EXERA II ULTRASOUND GASTROVIDEOSCOPE9 models · 8,317 reports · 2 recalls
- EVIS EXERA III BRONCHOVIDEOSCOPE11 models · 6,060 reports · 16 recalls
- EVIS EXERA III XENON LIGHT SOURCE2 models · 6,694 reports
- EVIS EXERA III COLONOVIDEOSCOPE6 models · 6,117 reports · 5 recalls
- EVIS EXERA III DUODENOVIDEOSCOPE OLYMPUS TJF-Q190V2 models · 5,281 reports · 4 recalls
- HD CAMERA HEAD2 models · 5,217 reports
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- 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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