4K CAMERA HEAD OLYMPUS CH-S400-XZ-EARecalls & reported problems

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Quick summary

This Olympus 4K camera head is the imaging unit used with endoscopes for gastroenterology and urology procedures. Its 2,353 reports often describe no image or display on the screen, communication problems and poor image quality, and mention 7 injuries and no deaths. 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: 2,375
Deaths reported: 0
Injuries reported: 7
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 2,375 adverse event reports that list this exact device (DI 04953170375552), received between Jul 2, 2020 and Sep 30, 2026 — classified as 7 injuries, 2,368 malfunctions.

The most frequently reported specific device problem is “No Display/Image” (1,147 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

Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

No Display/Image1,147
Communication or Transmission Problem469
Poor Quality Image370
Connection Problem104
Leak/Splash72
Output Problem65
Erratic or Intermittent Display62
Material Split, Cut or Torn62

Patient problems

No Clinical Signs, Symptoms or Conditions2,334
No Patient Involvement25
No Consequences Or Impact To Patient12
Insufficient Information3
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1

Recent adverse event reports

The 25 most recent of 2,375 reports, 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 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, 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 50899956 ↗
MalfunctionSep 18, 2026Crack
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50818709 ↗
MalfunctionSep 17, 2026No Display/Image; Connection Problem; Gas/Air Leak
The customer reported whenever they were plugged into the processor, nothing happened during inspection for use of an Olympus autoclavable camera head. During the initial evaluation of the device, it was observed no image displayed on the monitor due to a faulty cable/connector; and water leaked between the rear cover and COS ring. There was no patient involvement reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50808882 ↗
MalfunctionSep 17, 2026No Display/Image; Loose or Intermittent Connection; Gas/Air Leak
The customer reported that autoclavable camera head was not recognized during inspection for use. During the initial evaluation of the device, the unit failed the water leak test, and no image was observed. No patient involvement was reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50802952 ↗
MalfunctionSep 17, 2026Poor Quality Image; Gas/Air Leak
It was reported that the camera head had a blurry image. During evaluation the service center observe a leak. There were no reports of patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50801455 ↗
MalfunctionSep 15, 2026Connection Problem; Gas/Air Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50780308 ↗
MalfunctionSep 15, 2026No Display/Image
The customer reported no picture issue during an unspecified procedure involving an Olympus camera head. There was no patient injury reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50773954 ↗
MalfunctionSep 14, 2026No Display/Image; Communication or Transmission Problem
The customer reported light cord was not white balance involving an Olympus camera head. During initial evaluation it was observer, Error code E224 showing on image. There were no reports of patient harm.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50755969 ↗
MalfunctionSep 14, 2026No Display/Image
The customer reported no image, at all just a black screen during inspection for use involving an Olympus Autoclavable Camera Head. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50754832 ↗
MalfunctionSep 14, 2026Break; Poor Quality Image
The customer reported bad image and defect in the glass involving an Olympus autoclavable camera head. There were no reports of patient harm.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50751809 ↗
MalfunctionSep 11, 2026Display or Visual Feedback Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50741772 ↗
MalfunctionSep 11, 2026Poor Quality Image; Scratched Material
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50739764 ↗
MalfunctionSep 11, 2026No Display/Image; Leak/Splash; Connection Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50736874 ↗
MalfunctionSep 11, 2026Poor Quality Image; Output Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50735597 ↗
MalfunctionSep 11, 2026Break; Poor Quality Image
The customer reported a bad image and a defect in the glass involving an Olympus autoclavable camera head. There was no patient injury reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50728895 ↗
MalfunctionSep 10, 2026Connection Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50716736 ↗
MalfunctionSep 9, 2026Erratic or Intermittent Display; No Display/Image
The customer reported the autoclavable camera head dull light source image flickering. During the initial evaluation of the returned device, no image was shown on the screen. There was no patient injury reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50682288 ↗
MalfunctionSep 2, 2026Communication or Transmission Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50555958 ↗
MalfunctionAug 31, 2026Blocked Connection
Patient problems: Insufficient Information
MAUDE report 50533176 ↗

Device details

UDI-DI	`04953170375552`
Brand	4K CAMERA HEAD
Model	OLYMPUS CH-S400-XZ-EA
Company	Olympus Medical Systems Corp.
Product code	FET · Endoscopic video imaging system/component, gastroenterology-urology
Class	Class 2
FDA submission	K172817
Implant	No
Rx / OTC	Prescription
Single use	No
Sterile	No
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	Apr 22, 2024

Device type (GMDN): Endoscope video camera

An electro-optical device (e.g., a CCD) designed to be attached, either directly or with an adaptor, to a flexible or rigid endoscope to allow real-time viewing of the internal anatomy during an endoscopic surgical procedure and to obtain moving-picture documentation of endoscopic findings and procedures. The device is designed for transducing visual images as a sequence of electronic data following a pre-established standard; the images are usually displayed sequentially on the screen of a monitor as a video image. The device may include audio recording capabilities.

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