HD 3CMOS AUTOCLAVABLE CAMERA HEAD OLYMPUS CH-S200-XZ-EARecalls & reported problems
Olympus Medical Systems Corp. · HD 3CMOS AUTOCLAVABLE CAMERA HEAD · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This Olympus autoclavable camera head is a camera used with endoscopes. Many of its 1,092 reports describe no image appearing, poor image quality or communication errors, and some describe leaks. The reports include no deaths and 6 injuries. 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
- 1,110
- Deaths reported
- 0
- Injuries reported
- 6
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1,110 adverse event reports that list this exact device (DI 04953170393204), received between Aug 19, 2020 and Sep 30, 2026 — classified as 6 injuries, 1,104 malfunctions.
The most frequently reported specific device problem is “No Display/Image” (305 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
- No Display/Image305
- Poor Quality Image260
- Communication or Transmission Problem208
- Leak/Splash106
- Gas/Air Leak55
- Material Split, Cut or Torn51
- Break39
- Connection Problem32
Patient problems
- No Clinical Signs, Symptoms or Conditions1,097
- Insufficient Information6
- No Consequences Or Impact To Patient3
- Bowel Perforation1
- Electric Shock1
- Hemorrhage/Blood Loss/Bleeding1
- Laceration(s)1
- No Patient Involvement1
Recent adverse event reports
The 25 most recent of 1,110 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 2026Communication or Transmission Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50955122 ↗MalfunctionSep 30, 2026Poor Quality Image
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50949749 ↗MalfunctionSep 30, 2026Gas/Air Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50949578 ↗MalfunctionSep 30, 2026Gas/Air Leak
The customer reported the Olympus camera head had a separate issue. During the initial evaluation of the device it was observed, failed leak test. No patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50941899 ↗MalfunctionSep 28, 2026Poor Quality Image
The customer reported that the image was blurry 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 50915894 ↗MalfunctionSep 23, 2026Gas/Air Leak
The customer returned the autoclavable camera head for a separate issue. 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 50867228 ↗MalfunctionSep 22, 2026No Display/Image
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50861455 ↗MalfunctionSep 17, 2026Break; Use of Device Problem; Output Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50810143 ↗MalfunctionSep 15, 2026Poor Quality Image; Connection Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50782177 ↗MalfunctionSep 15, 2026Poor Quality Image
The customer reported dark image displayed involving an Olympus autoclavable camera head. There was no patient injury reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50774799 ↗MalfunctionSep 11, 2026Material Puncture/Hole
The customer returned the autoclavable camera head for a separate issue. During the initial evaluation of the returned device, pin hole close to CCD (charged coupled device) side was observed. No patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50732181 ↗MalfunctionSep 10, 2026Optical Discoloration
No additional information received from the customer.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50721079 ↗MalfunctionSep 10, 2026Poor Quality Image; Output Problem
The customer reported dark image and dull light during inspection for use involving an Olympus autoclavable camera head. There were no reports of patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50706696 ↗MalfunctionSep 1, 2026Leak/Splash
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50547607 ↗MalfunctionSep 1, 2026Leak/Splash
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50546942 ↗MalfunctionSep 1, 2026Leak/Splash; Poor Quality Image
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50546833 ↗MalfunctionSep 1, 2026Corroded; Erratic or Intermittent Display; Leak/Splash
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50545662 ↗MalfunctionSep 1, 2026Poor Quality Image
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50542133 ↗MalfunctionAug 31, 2026Gas/Air Leak
The customer reported the autoclavable camera head had a separate issue. During the initial evaluation of the returned device, a failed water leak test was observed. No patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50533092 ↗MalfunctionAug 27, 2026Communication or Transmission Problem; Gas/Air Leak
The customer reported E226 scope communication error during inspection for use involving an Olympus Autoclavable Camera Head. There was no patient involvement reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50476130 ↗MalfunctionAug 19, 2026Leak/Splash; Poor Quality Image; Communication or Transmission Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50327482 ↗MalfunctionAug 18, 2026No Display/Image; Leak/Splash
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50309453 ↗MalfunctionAug 17, 2026Leak/Splash; Communication or Transmission Problem
The customer reported error 226 during Sedation - Device outside patient for Cystoscopy Diagnostic type procedure involving an Olympus autoclavable camera head. The procedure was completed with similar device. There was no patient injury reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50273547 ↗MalfunctionAug 12, 2026Poor Quality Image
The customer reported image issue with white balancing involving an Olympus autoclavable camera head. There was no patient injury reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50225377 ↗MalfunctionAug 11, 2026Connection Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50215429 ↗
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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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