HD AUTOCLAVABLE CAMERA HEAD OLYMPUS CH-S190-XZ-QRecalls & reported problems
Olympus Medical Systems Corp. · 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 is an endoscope accessory used for narrow-band imaging. The 26 reports describe image problems such as white dots, flickering, blurry or dark pictures, loss of picture, and connection issues, often found during inspection or maintenance without patient involvement. There are 26 reports, with no deaths and no injuries, and no recalls name this device. Reports fell from 9 in the prior period to 0 in the most recent period.
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
- 26
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 26 adverse event reports that list this exact device (DI 04953170310782), received between Jun 24, 2020 and Aug 28, 2025 — classified as 26 malfunctions.
The most frequently reported specific device problem is “Poor Quality Image” (8 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 Image8
- Communication or Transmission Problem6
- No Display/Image5
- Material Deformation3
- Erratic or Intermittent Display2
- Leak/Splash2
- Corroded1
- Device Alarm System1
Patient problems
- No Clinical Signs, Symptoms or Conditions24
- No Consequences Or Impact To Patient2
- No Patient Involvement1
Recent adverse event reports
The 25 most recent of 26 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 28, 2025Poor Quality Image; Poor Quality Image
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE SUBJECT DEVICE EXHIBITED DISCONNECTION IN CAMERA UNIT AND THE IMAGE HAD WHITE DOTS. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22911661 ↗MalfunctionJul 8, 2025Erratic or Intermittent Display; Erratic or Intermittent Display
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE SUBJECT DEVICE EXHIBITED IMAGE HAS INTERMITTENT PROBLEM. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22441716 ↗MalfunctionApr 28, 2025Scratched Material; Scratched Material
IT WAS REPORTED THAT THE SUBJECT DEVICE HAD A SCRATCHED LENS AND MARKS. THE EVENT OCCURRED DURING REPROCESSING. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21919887 ↗MalfunctionMar 17, 2025Poor Quality Image; Failure to Align; Poor Quality Image; Failure to Align
IT WAS REPORTED THAT THE SUBJECT DEVICE EXHIBITED A GASKET WAS MISALIGNED AND SHADOW ON THE IMAGE, THE ISSUE OCCURRED DURING INSPECTION FOR USE BEFORE THE PATIENT ROOM. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21620950 ↗MalfunctionJan 16, 2025Poor Quality Image; Poor Quality Image
IT WAS REPORTED THAT THE SUBJECT DEVICE HAD BLURRY, DARK, AND FOGGY IMAGE. THE ISSUE WAS FOUND DURING MAINTENANCE. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21167748 ↗MalfunctionJan 2, 2025Corroded; Erratic or Intermittent Display; Corroded; Erratic or Intermittent Display
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE CAMERA HEAD EXHIBITED IMAGE FLICKERING AND CORROSION OF ELECTRICAL CONTACT POINTS. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21057357 ↗MalfunctionDec 30, 2024Leak/Splash; Leak/Splash
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE CAMERA HEAD EXHIBITED POOR WATERTIGHTNESS. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21039875 ↗MalfunctionDec 28, 2024Poor Quality Image; Poor Quality Image
NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21032052 ↗MalfunctionNov 25, 2024Poor Quality Image; Communication or Transmission Problem; Poor Quality Image; Communication or Transmission Problem
IT WAS REPORTED THAT THE SUBJECT DEVICE DISPLAYED AN IMAGE THAT WENT FUZZY, THEN WENT BLACK AND SHOWED A SCOPE COMMUNICATION ERROR CODE B30. THE ISSUE WAS IDENTIFIED DURING A SEDATION OF DIAGNOSTIC KNEE ARTHROSCOPY PROCEDURE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20772054 ↗MalfunctionJul 2, 2024Communication or Transmission Problem; Communication or Transmission Problem
IT WAS REPORTED THAT DURING PREPARATION FOR USE FOR AN UNKNOWN PROCEDURE, THE SUBJECT DEVICE HAD B30 SCOPE COMMUNICATION ERROR. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19654358 ↗MalfunctionMay 23, 2024Poor Quality Image; Material Deformation; Poor Quality Image; Material Deformation
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE CAMERA HEAD EXHIBITED A SMASHED CONNECTOR TIP AND THE CHARGED COUPLED DEVICE CAUSED A BLURRY IMAGE. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19382972 ↗MalfunctionFeb 29, 2024Gas/Air Leak; Gas/Air Leak
IT WAS REPORTED THAT THE CAMERA HEAD HAD AN AIR LEAKAGE FROM MAIN BODY. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18812622 ↗MalfunctionFeb 22, 2024Fluid/Blood Leak; Fluid/Blood Leak
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE CAMERA HEAD EXHIBITED FLOODING IN THE MAIN UNIT IMAGING AND WATER IMMERSION IN THE CAMERA CABLE. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18764580 ↗MalfunctionFeb 14, 2024No Display/Image; No Display/Image
THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER AND THE LEGAL MANUFACTURER¿S FINAL INVESTIGATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18707912 ↗MalfunctionJan 5, 2024Disconnection; Leak/Splash; Poor Quality Image; Material Deformation; Disconnection; Leak/Splash; Poor Quality Image; Material Deformation
THE END USER FACILITY CONTACTED OLYMPUS TO REPORT WHEN THEY TRIED TO ATTACH THE SCOPE TO THE HD AUTOCLAVABLE CAMERA HEAD, THE CAMERA HEAD SPINS FREELY. THERE WAS NO RESISTANCE, SOMETHING WAS WRONG WITH THE COUPLER NO PATIENT OR USER HARM HAS BEEN REPORTED. NO PROCEDURAL DELAYS HAVE BEEN REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18458506 ↗MalfunctionJun 20, 2023Electrical /Electronic Property Problem; Electrical /Electronic Property Problem
THE CUSTOMER REPORTED TO OLYMPUS, THE QUICK LOCK PART OF THE HD AUTOCLAVABLE CAMERA HEAD WAS DAMAGED. INSPECTION AND TESTING OF THE RETURNED DEVICE FOUND CABLE FAILURE. THERE WERE NO REPORTS OF PATIENT HARM. THIS MEDICAL DEVICE REPORT (MDR) IS BEING SUBMITTED TO CAPTURE THE REPORTABLE MALFUNCTION FOUND DURING EVALUATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17167766 ↗MalfunctionMay 9, 2023Communication or Transmission Problem; Communication or Transmission Problem
THE CUSTOMER REPORTED TO OLYMPUS, THERE WAS A E315 UNSUPPORTED SCOPE ERROR WHEN CONNECTING TO THE HD AUTOCLAVABLE CAMERA HEAD TO THE CV-190 TOWER. THE CUSTOMER STATED THAT CAMERA HEAD WAS CONNECTED TO A DIFFERENT THE CV-190 TOWER AND RECEIVED THE SAME ERROR CODE. THERE WERE NO REPORTS OF PATIENT HARM ASSOCIATED WITH THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16900198 ↗MalfunctionApr 25, 2023Poor Quality Image; Communication or Transmission Problem; Poor Quality Image; Communication or Transmission Problem
AN OLYMPUS REPRESENTATIVE REPORTED (ON BEHALF OF THE CUSTOMER), THAT THE IMAGE TURNS BLUE WHEN USING THE HD AUTOCLAVABLE CAMERA HEAD. THE DEVICE WAS INSPECTED PRIOR TO USE. AND THE THORACOSCOPIC PARTIAL LUNG RESECTION PROCEDURE WAS COMPLETED WITH A SIMILAR DEVICE. THERE WAS NO PATIENT HARM ASSOCIATED WITH THE EVENT. UPON INSPECTION AND TESTING OF THE CUSTOMER RETURNED DEVICE, SCOPE COMMUNICATION B30 ERROR AND SANDSTORM "IMAGE NOISE" WAS IDENTIFIED. THIS MEDICAL DEVICE REPORT (MDR) IS BEING SUBMITTED TO CAPTURE THE REPORTABLE MALFUNCTION FOUND DURING EVALUATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16807327 ↗MalfunctionNov 17, 2022No Display/Image; No Display/Image
THE CUSTOMER REPORTED TO OLYMPUS DURING PREPARATION FOR USE, THERE WAS NO IMAGE; A PICTURE SWITCHES ON AND OFF, AS WELL AS FOCUSING IN AND OUT ON THE HD AUTOCLAVABLE CAMERA HEAD. THERE WERE NO REPORTS OF PATIENT HARM ASSOCIATED WITH THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15811939 ↗MalfunctionJul 14, 2022Communication or Transmission Problem; Communication or Transmission Problem
THE CUSTOMER REPORTED THE HD AUTOCLAVABLE CAMERA HEAD DISPLAY A B30 ERROR. THERE WAS NO PATIENT HARM OR USER INJURY REPORTED DUE TO THE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15015973 ↗MalfunctionJun 1, 2022No Display/Image; No Display/Image
THE CUSTOMER REPORTED TO OLYMPUS DURING A UNKNOWN PROCEDURE, NO IMAGE/ PICTURE ON THE HD AUTOCLAVABLE CAMERA HEAD. THERE WERE NO REPORTS OF PATIENT HARM ASSOCIATED WITH THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14569767 ↗MalfunctionMar 15, 2022Material Deformation; Material Deformation
THE CUSTOMER REPORTED THAT WHEN PREPARING THE SUBJECT DEVICE FOR USE, THE SCOPE COUPLING WAS FOUND TO BE DETACHED FROM THE CAMERA HEAD. THE INTENDED ORTHOPEDIC KNEE PROCEDURE WAS COMPLETED WITH A SIMILAR DEVICE. THERE WAS NO DELAY IN THE PROCEDURE. THERE WAS NO PATIENT/USER HARM OR INJURY REPORTED DUE TO THE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13773623 ↗MalfunctionMar 10, 2022No Display/Image; No Display/Image
THE CUSTOMER REPORTED TO OLYMPUS THEIR HD AUTOCLAVABLE CAMERA HEAD DID NOT DISPLAY AN IMAGE AND WILL NOT CAPTURE A PICTURE. THERE WAS NO REPORTS OF PATIENT DEATH, HARM, OR INJURIES RELATED TO THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13720118 ↗MalfunctionFeb 4, 2021No Display/Image; No Display/Image
A SURGICAL SUPPLY COORDINATOR AT A USER FACILITY REPORTED THAT THE IMAGE DID NOT APPEAR AND THAT THE CAMERA FOCUS WAS NOT WORKING WHILE USING A CAMERA HEAD. THE PROBLEM WAS FIRST NOTICED BEFORE A PROCEDURE. THERE WAS NO DELAY IN THE PROCEDURE IN WHICH THE SUBJECT DEVICE WAS USED. THE INTENDED PROCEDURE WAS COMPLETED. NO PATIENT INVOLVEMENT OR INJURY WAS REPORTED. NO ADDITIONAL INFORMATION HAS BEEN OBTAINED.
Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient
MAUDE report 11280531 ↗MalfunctionJan 14, 2021Device Alarm System; Device Alarm System
A USER FACILITY REPORTED A B30 ERROR-SCOPE COMMUNICATION ERROR WHILE USING A CAMERA HEAD DURING A PROCEDURE. THERE WAS NO PATIENT INJURY OR HARM REPORTED. NO ADDITIONAL INFORMATION HAS BEEN OBTAINED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 11169657 ↗
Other Endoscope, accessories, narrow band spectrum devices
- EVIS EXERA III VIDEO SYSTEM CENTER OLYMPUS CV-190Olympus Medical Systems Corp. · Endoscope, accessories, narrow band spectrum1 recall7,688 reports
- HD CAMERA HEAD OLYMPUS CH-S190-08-LBOlympus Medical Systems Corp. · Endoscope, accessories, narrow band spectrum3,793 reports
- EVIS EXERA III COLONOVIDEOSCOPE OLYMPUS PCF-HQ190LOlympus Medical Systems Corp. · Endoscope, accessories, narrow band spectrum2 recalls2,828 reports
- EVIS EXERA II DUODENOVIDEOSCOPE TJF-Q180VOlympus Medical Systems Corp. · Endoscope, accessories, narrow band spectrum6 deaths2,362 reports
- VISERA ELITE VIDEO SYSTEM CENTER OLYMPUS OTV-S190Olympus Medical Systems Corp. · Endoscope, accessories, narrow band spectrum1,563 reports
- HD AUTOCLAVABLE CAMERA HEAD OLYMPUS CH-S190-XZ-EOlympus Medical Systems Corp. · Endoscope, accessories, narrow band spectrum1,424 reports
- VIDEO SYSTEM CENTER Type A OLYMPUS CV-170Olympus Medical Systems Corp. · Endoscope, accessories, narrow band spectrum841 reports
- EVIS EXERA II DUODENOVIDEOSCOPE TJF-Q180VOlympus Medical Systems Corp. · Endoscope, accessories, narrow band spectrum1 recall3 deaths653 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.
How reports and recalls are matched · Editorial policy · Report an error on this page