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

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

Quick summary

This Olympus 4K endoscope camera head has 2,511 adverse event reports, with no deaths and 14 injuries. Most reports describe no display or image, signal transmission problems, and poor image quality, and some mention leaks. Reports fell to 225 in the last 12 months from 364 in the 12 months before. 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: 2,522
Deaths reported: 0
Injuries reported: 14
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 2,522 adverse event reports that list this exact device (DI 04953170374609), received between Oct 1, 2018 and Sep 30, 2026 — classified as 14 injuries, 2,508 malfunctions.

The most frequently reported specific device problem is “No Display/Image” (1,406 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/Image1,406
Communication or Transmission Problem417
Poor Quality Image291
Connection Problem88
Leak/Splash64
Break61
Output Problem61
Display or Visual Feedback Problem56

Patient problems

No Clinical Signs, Symptoms or Conditions2,459
No Patient Involvement32
No Consequences Or Impact To Patient27
Insufficient Information3
No Known Impact Or Consequence To Patient3
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1

Recent adverse event reports

The 25 most recent of 2,522 reports, in the reporter's own words as published by the FDA.

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 25, 2026No Display/Image
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50905980 ↗
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 ↗
MalfunctionSep 21, 2026Communication or Transmission Problem; Key or Button Unresponsive/not Working
The customer reported the camera head error code popped up during a unspecified therapeutic procedure. During the initial evaluation of the device it was observed, camera head communication error E224 and intermittent switch. No patient harm was reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50840953 ↗
MalfunctionSep 17, 2026No Display/Image
The customer reported no image is shown during inspection for use involving an Olympus camera head. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50805875 ↗
MalfunctionSep 17, 2026Poor Quality Image
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50797078 ↗
MalfunctionSep 16, 2026Leak/Splash; Detachment of Device or Device Component
The customer returned the camera head for a separate issue. During the initial evaluation of the returned device, a loss of watertightness and the coupler was found to detach from the scope were observed. No patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50782601 ↗
MalfunctionSep 14, 2026Connection Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50765014 ↗
MalfunctionSep 14, 2026Leak/Splash; Scratched Material
The customer reported damage to the head during inspection for use involving an Olympus Camera Head. During the initial evaluation of the returned device, compromised water tightness, was observed. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50755633 ↗
MalfunctionSep 10, 2026Key or Button Unresponsive/not Working
The customer reported that the device was not working involving an Olympus camera head. No patient injury was reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50717448 ↗
MalfunctionSep 2, 2026Poor Quality Image; Fitting Problem; Communication or Transmission Problem; Noise, Audible
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50566184 ↗
MalfunctionSep 2, 2026Communication or Transmission Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50555947 ↗
MalfunctionAug 31, 2026No Display/Image; Loose or Intermittent Connection; Optical Discoloration
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50532173 ↗
MalfunctionAug 31, 2026No Display/Image; Loose or Intermittent Connection
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50519925 ↗
MalfunctionAug 26, 2026Loose or Intermittent Connection
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50459926 ↗
MalfunctionAug 20, 2026Break; Leak/Splash; Loose or Intermittent Connection; Unstable
The customer reported the Camera Head did not stay locked in the tower during reprocessing. During the initial evaluation of the device, Error E224, Bad cable or connector, and water leakage were observed. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50345141 ↗
MalfunctionAug 19, 2026Poor Quality Image
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50325162 ↗
MalfunctionAug 18, 2026Leak/Splash
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50291769 ↗
MalfunctionAug 17, 2026Loose or Intermittent Connection
No additional information received from the customer.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50290055 ↗
MalfunctionAug 17, 2026Communication or Transmission Problem
The customer reported Communication error during an inspection for use involving an Olympus camera head. There was no patient involvement reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50273774 ↗
MalfunctionAug 12, 2026Poor Quality Image
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50223660 ↗
MalfunctionAug 10, 2026Communication or Transmission Problem
The customer reported communication error during inspection for use involving an Olympus camera head. There was no patient harm.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50193862 ↗
MalfunctionAug 9, 2026Optical Discoloration
The customer reported the camera head had failed white balance. During the initial evaluation of the device it was observed, grinding noise on coupler, water leaked between up mark and electrical contract. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50188178 ↗

Device details

UDI-DI	`04953170374609`
Brand	4K CAMERA HEAD
Model	OLYMPUS CH-S400-XZ-EB
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.

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