HD 3CMOS CAMERA HEAD OLYMPUS CH-S200-XZ-EBRecalls & reported problems
Olympus Medical Systems Corp. · HD 3CMOS CAMERA HEAD · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This Olympus HD 3CMOS camera head has 692 adverse event reports, with no deaths and no injuries. Common problems include poor image quality, no display or image, communication failures and fluid leaks; some reports describe blurry images during reprocessing. No recalls name this device. Reports dropped, with 71 in the last year compared with 128 in the year before.
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
- 698
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 698 adverse event reports that list this exact device (DI 04953170379611), received between Apr 26, 2021 and Sep 22, 2026 — classified as 698 malfunctions.
The most frequently reported specific device problem is “Poor Quality Image” (229 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
Most reported problems
Device problems
- Poor Quality Image229
- No Display/Image160
- Communication or Transmission Problem113
- Leak/Splash74
- Erratic or Intermittent Display37
- Break35
- Gas/Air Leak32
- Failure to Power Up24
Patient problems
- No Clinical Signs, Symptoms or Conditions697
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
Recent adverse event reports
The 25 most recent of 698 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 22, 2026Poor Quality Image
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50861408 ↗MalfunctionSep 14, 2026Poor Quality Image
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50764255 ↗MalfunctionSep 10, 2026Leak/Splash; Poor Quality Image
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50723272 ↗MalfunctionSep 10, 2026Poor Quality Image
The customer reported a blurry and unclear image, and that the light might be dim, 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 50704800 ↗MalfunctionSep 9, 2026Optical Discoloration
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50695725 ↗MalfunctionSep 8, 2026Poor Quality Image
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50676122 ↗MalfunctionSep 2, 2026Poor Quality Image
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50566542 ↗MalfunctionSep 2, 2026Poor Quality Image
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50566422 ↗MalfunctionAug 28, 2026Poor Quality Image
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50501294 ↗MalfunctionAug 12, 2026Poor Quality Image
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50229010 ↗MalfunctionAug 12, 2026Poor Quality Image
The customer reported blurry involving an Olympus camera head. There was no patient injury reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50225592 ↗MalfunctionAug 3, 2026Poor Quality Image
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50114214 ↗MalfunctionJul 28, 2026
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50058129 ↗MalfunctionJul 28, 2026Erratic or Intermittent Display; Intermittent Loss of Power
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50055871 ↗MalfunctionJul 16, 2026Leak/Splash
THE CUSTOMER REPORTED FLUID INGRESS INVOLVING AN OLYMPUS CAMERA HEAD. THERE WAS NO PATIENT INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25842886 ↗MalfunctionJul 9, 2026Gas/Air Leak
THE CUSTOMER RETURNED THE CAMERA HEAD TO THE SERVICE CENTER FOR A SEPARATE ISSUE. DURING THE DEVICE ANALYSIS, THE SERVICE REPAIR TECHNICIAN INDICATES THAT FAILED LEAK TEST WAS FOUND. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25766089 ↗MalfunctionJun 22, 2026Moisture Damage
THE CUSTOMER RETURNED THE CAMERA HEAD TO THE SERVICE CENTER FOR A SEPARATE ISSUE. DURING THE DEVICE ANALYSIS, THE TECHNICAL ASSISTANCE INDICATED MOISTURE INSIDE CHARGED COUPLED DEVICE LENS. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25578832 ↗MalfunctionJun 15, 2026Crack
THE CUSTOMER REPORTED CHIPPED VIDEO CONNECTOR EDGE DURING DEVICE INSPECTION FOR USE INVOLVING AN OLYMPUS CAMERA HEAD. THERE WAS NO PATIENT INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25506092 ↗MalfunctionJun 8, 2026Poor Quality Image
THE CUSTOMER RETURNED THE CAMERA HEAD WHICH IS AN OLYMPUS ASSET WITH NO REPORTED COMPLAINT. DURING THE DEVICE ANALYSIS, THE SERVICE CENTER TECHNICIAN INDICATES THAT A BLURRY IMAGE WAS FOUND. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25429107 ↗MalfunctionJun 8, 2026Gas/Air Leak
THE CUSTOMER RETURNED THE CAMERA HEAD TO THE SERVICE CENTER FOR A SEPARATE. DURING THE DEVICE ANALYSIS, THE SERVICE REPAIR TECHNICIAN INDICATES THAT A FAILED WATER LEAK TEST WAS FOUND. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25424727 ↗MalfunctionMay 25, 2026Connection Problem
IT WAS REPORTED THAT THE CAMERA HEAD HAD A BAD ELECTRICAL CONNECTION. THE EVENT OCCURRED DURING AN UNSPECIFIED PROCEDURE BEFORE SEDATION. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25272126 ↗MalfunctionMay 23, 2026Gas/Air Leak
THE CUSTOMER RETURNED THE CAMERA HEAD TO THE SERVICE CENTER FOR A SEPARATE ISSUE. DURING THE DEVICE ANALYSIS, THE SERVICE TEAM INDICATES THAT A FAILED LEAK TEST WAS FOUND ON TIP. IT WAS DETERMINED THAT THE TIP NEEDED TO BE REPLACED. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25264680 ↗MalfunctionMay 23, 2026No Device Output
IT WAS REPORTED THAT THE CAMERA HEAD HAD STOPPED WORKING. THE EVENT OCCURRED DURING DIAGNOSTIC PROCEDURE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25264371 ↗MalfunctionMay 20, 2026Degraded; No Display/Image
IT WAS REPORTED THAT THE ELECTRICAL CONTACTS OF THE VIDEO CONNECTOR ON THE CAMERA HEAD WERE DAMAGED, AND ERROR 226 WAS ALSO DISPLAYED. THE ISSUE OCCURRED DURING PREPARATION FOR USE, AND NO PATIENT HARM WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25229768 ↗MalfunctionMay 19, 2026No Device Output
IT WAS REPORTED THAT THE CAMERA HEAD WAS NOT WORKING DURING INSPECTION FOR USE. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25213254 ↗
Other Confocal Optical Imaging devices
- HD 3CMOS AUTOCLAVABLE CAMERA HEAD OLYMPUS CH-S200-XZ-EAOlympus Medical Systems Corp. · Confocal Optical Imaging1,110 reports
- VISERA ELITE II VIDEO SYSTEM CENTER OLYMPUS OTV-S200Olympus Medical Systems Corp. · Confocal Optical Imaging870 reports
- L11 0220230300Stryker Corporation · Confocal optical imaging233 reports
- L10 0220220300Stryker Corporation · Confocal optical imaging77 reports
- AIM SafeLight 0233050300Stryker Corporation · Confocal optical imaging62 reports
- SafeLight 0233050400Stryker Corporation · Confocal optical imaging56 reports
- 1588 AIM 1588010000Stryker Corporation · Confocal optical imaging35 reports
- 1588 AIM 1588020122Stryker Corporation · Confocal optical imaging26 reports
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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