HD CAMERA HEAD OLYMPUS CH-S190-08-LBRecalls & reported problems
Olympus Medical Systems Corp. · CH-S190-08-LB HD ULTRA-LIGHT URO CAMERA · Class 2
All models of HD CAMERA HEAD (2)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This Olympus HD camera head is an ultra-light camera attached to urology endoscopes. Many reports describe no image on the screen or poor image quality, and some describe cracks, leaks or communication errors. The 3,746 reports include 1 injury and no deaths. 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
- 3,793
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3,793 adverse event reports that list this exact device (DI 04953170336669), received between Aug 11, 2020 and Sep 30, 2026 — classified as 1 injury, 3,792 malfunctions.
The most frequently reported specific device problem is “No Display/Image” (1,145 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/Image1,145
- Poor Quality Image1,064
- Material Split, Cut or Torn235
- Communication or Transmission Problem230
- Leak/Splash215
- Break181
- Detachment of Device or Device Component131
- Erratic or Intermittent Display110
Patient problems
- No Clinical Signs, Symptoms or Conditions3,778
- No Patient Involvement8
- No Consequences Or Impact To Patient4
- Insufficient Information3
Recent adverse event reports
The 25 most recent of 3,793 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 2026Crack
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50954396 ↗MalfunctionSep 30, 2026Moisture Damage; Material Split, Cut or Torn
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50949553 ↗MalfunctionSep 30, 2026No Display/Image
The customer reported no image was displayed during setup involving an Olympus autoclavable camera head. There was no patient involvement reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50948283 ↗MalfunctionSep 29, 2026Material Split, Cut or Torn
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50940789 ↗MalfunctionSep 29, 2026Poor Quality Image; Detachment of Device or Device Component
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50938874 ↗MalfunctionSep 29, 2026Detachment of Device or Device Component
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50938055 ↗MalfunctionSep 29, 2026Crack
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50937073 ↗MalfunctionSep 29, 2026Poor Quality Image
The customer reported blurry image during inspection for use involving an Olympus camera head. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50935965 ↗MalfunctionSep 29, 2026Loose or Intermittent Connection
The customer reported that the camera lock (coupler) is loose involving an Olympus camera head. There was no patient injury reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50933032 ↗MalfunctionSep 29, 2026Poor Quality Image
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50932522 ↗MalfunctionSep 29, 2026No Display/Image; Poor Quality Image
The customer reported that the Olympus camera head had no image during inspection for use. During the initial evaluation of the device, it was observed that the image had vertical distorted lines. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50932490 ↗MalfunctionSep 28, 2026Poor Quality Image
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50925371 ↗MalfunctionSep 25, 2026Communication or Transmission Problem
The customer reported communication error during an unspecified procedure involving an Olympus Autoclavable Camera Head. The procedure was completed with an Olympus back up device. There were no reports of patient harm.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50899791 ↗MalfunctionSep 24, 2026Display or Visual Feedback Problem
The customer reported that an image problem occurred involving an Olympus Autoclavable Camera Head. There was no patient injury reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50884598 ↗MalfunctionSep 24, 2026Break
The customer returned the Olympus camera head to the service center for a separate issue. During the device analysis, the service repair technician indicates that a faulty Charge coupler devide was found. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50882767 ↗MalfunctionSep 22, 2026Poor Quality Image; Gas/Air Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50862586 ↗MalfunctionSep 22, 2026Detachment of Device or Device Component
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50861593 ↗MalfunctionSep 22, 2026Communication or Transmission Problem; Connection Problem
The customer reported the autoclavable camera head did not connect to the tower during inspection for use. During the initial evaluation of the device, a scope communication error (B30) was observed. No patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50850565 ↗MalfunctionSep 22, 2026Poor Quality Image
The customer reported that the camera head had video issues during reprocessing. During the initial evaluation of the device, it was observed that the device failed water leak test due to the puncture on the cable. No patient involvement was reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50849795 ↗MalfunctionSep 21, 2026Moisture Damage; Gas/Air Leak; Optical Discoloration
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50847336 ↗MalfunctionSep 21, 2026Detachment of Device or Device Component
The customer reported that the lens was out during inspection for use of an Olympus autoclavable camera head. There were no reports of patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50843124 ↗MalfunctionSep 21, 2026Gas/Air Leak
The customer reported the autoclavable 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 50841339 ↗MalfunctionSep 21, 2026No Display/Image
The customer reported no image during an inspection for use involving an Olympus camera head. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50841237 ↗MalfunctionSep 21, 2026Detachment of Device or Device Component
The customer reported during Loose center glass piece and pan reprocessing involving an Olympus camera head. There were no reports of patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50837361 ↗MalfunctionSep 18, 2026No Display/Image
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50829615 ↗
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
- 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
- SINGLE USE DISTAL COVER MAJ-2315Olympus Medical Systems Corp. · Endoscope, accessories, narrow band spectrum1 recall520 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