HD AUTOCLAVABLE CAMERA HEAD OLYMPUS CH-S190-XZ-ERecalls & reported problems
Olympus Medical Systems Corp. · CH-S190-XZ-E 3CCD CAMERA HEAD EYEPIECE · Class 2
All models of HD AUTOCLAVABLE CAMERA HEAD (6)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This Olympus autoclavable camera head has 1,413 FDA adverse event reports, with 5 injuries, 1,408 malfunctions and no deaths. The reports mostly describe poor or intermittent images, no image on the display, and cable or transmission problems, with some describing leaks, breaks or corrosion. 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
- 1,424
- Deaths reported
- 0
- Injuries reported
- 5
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1,424 adverse event reports that list this exact device (DI 04953170310799), received between Jun 5, 2019 and Sep 30, 2026 — classified as 5 injuries, 1,419 malfunctions.
The most frequently reported specific device problem is “Poor Quality Image” (490 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 Image490
- No Display/Image300
- Communication or Transmission Problem177
- Break103
- Leak/Splash89
- Corroded66
- Material Split, Cut or Torn59
- Erratic or Intermittent Display48
Patient problems
- No Clinical Signs, Symptoms or Conditions1,396
- No Patient Involvement18
- No Consequences Or Impact To Patient7
- Insufficient Information5
Recent adverse event reports
The 25 most recent of 1,424 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 2026Poor Quality Image; Noise, Audible
The customer returned the Autoclavable camera head to the service center for a separate issue. During the initial device analysis, the service technician identified poor color image on the screen. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50946466 ↗MalfunctionSep 29, 2026Poor Quality Image; Gas/Air Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50935452 ↗MalfunctionSep 25, 2026No Display/Image; Leak/Splash; Communication or Transmission Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50905310 ↗MalfunctionSep 24, 2026Optical Discoloration
The customer reported will not white set displayed involving an Olympus autoclavable camera head. There was no patient injury reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50885022 ↗MalfunctionSep 22, 2026Leak/Splash; Poor Quality Image
The customer reported that the Autoclavable Camera Head had Image with static snow, coudn't see anything during inspection for use. During the initial evaluation of the device failed leak test, was observed. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50854772 ↗MalfunctionSep 16, 2026Poor Quality Image; Communication or Transmission Problem
The customer reported error massage and fuzzy image during inspection for use involving an autoclavable camera head. There was no patient involvement reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50794801 ↗MalfunctionSep 14, 2026Poor Quality Image
The customer reported that they experienced a bad quality picture during inspection for use involving an Olympus Camera head. No reports of patient harm were received.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50756891 ↗MalfunctionSep 11, 2026Break; Leak/Splash
The customer returned the autoclavable camera head for a separate issue. During the initial evaluation of the returned device, the cable failed the leak test, and lens coupler was damaged. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50736696 ↗MalfunctionSep 10, 2026Gas/Air Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50719548 ↗MalfunctionSep 9, 2026Erratic or Intermittent Display; No Display/Image
The customer reported interference and image loss during maintenance involving an Olympus autoclavable camera head. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50693446 ↗MalfunctionSep 1, 2026Leak/Splash
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50542803 ↗MalfunctionAug 18, 2026Display or Visual Feedback Problem
The customer reported problem with image during service maintenance involving an Olympus camera head. Additionally, during the device analysis, Intermittent image and Failed leak test were observed. There was no patient injury reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50307500 ↗MalfunctionAug 16, 2026Disconnection; Display or Visual Feedback Problem; Gas/Air Leak
The customer reported the Autoclavable Camera Head had problem with the image during maintenance. During the initial evaluation of the device cable disconnection, Intermittent image and leakage from the cable was observed. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50268240 ↗MalfunctionAug 12, 2026Poor Quality Image
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50223751 ↗MalfunctionAug 11, 2026No Display/Image; Communication or Transmission Problem; Noise, Audible
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50216443 ↗MalfunctionAug 11, 2026Poor Quality Image
The customer returned the Olympus autoclavable camera head to the service center for a separate issue. During During the initialevaluation of the device three white dots were observed in the image. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50214401 ↗MalfunctionJul 31, 2026Noise, Audible
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50107719 ↗MalfunctionJul 31, 2026Poor Quality Image
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50097916 ↗MalfunctionJul 30, 2026Gas/Air Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50087077 ↗MalfunctionJul 29, 2026Gas/Air Leak
The customer returned the autoclavable camera head to the service center for a separate issue. During the device analysis, the Service Repair Technician indicates that failed leak test at cable was found. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50076197 ↗MalfunctionJul 28, 2026
The customer reported the scope was not working properly during setup involving an Olympus autoclavable camera head. There was no patient involvement reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50058825 ↗MalfunctionJul 28, 2026Poor Quality Image
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50056049 ↗MalfunctionJul 21, 2026Break; Gas/Air Leak
THE CUSTOMER RETURNED THE AUTOCLAVABLE CAMERA HEAD TO THE SERVICE CENTER FOR A SEPARATE ISSUE. DURING THE DEVICE ANALYSIS, THE SERVICE REPAIR TECHNICIAN INDICATES THAT LENS BROKEN AND FAILED LEAK TEST WAS FOUND. THERE WAS NO PATIENT INVOLVEMENT
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25892588 ↗MalfunctionJul 10, 2026Poor Quality Image; Detachment of Device or Device Component
THE CUSTOMER RETURNED THE AUTOCLAVABLE CAMERA HEAD TO THE SERVICE CENTER FOR A SEPARATE ISSUE. DURING DEVICE ANALYSIS, THE SERVICE TECHNICIAN IDENTIFIED THAT THE DEVICE EXHIBITED LINES ON THE IMAGE AND WAS MISSING A COUPLER SPRING. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25786073 ↗MalfunctionJul 6, 2026Gas/Air Leak
THE CUSTOMER RETURNED THE CAMERA HEAD TO THE SERVICE CENTER FOR A SEPARATE ISSUE. DURING THE DEVICE ANALYSIS, THE SERVICE REPORT TECHNICIAN INDICATES THAT FAILED LEAK TEST WAS FOUND. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25726560 ↗
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- EVIS EXERA II DUODENOVIDEOSCOPE TJF-Q180VOlympus Medical Systems Corp. · Endoscope, accessories, narrow band spectrum1 recall3 deaths653 reports
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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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