HD CAMERA HEADRecalls & reported problems across all models
Olympus Medical Systems Corp. · 2 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 5,217
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls
- 0
We found 2 models of HD CAMERA HEAD by Olympus Medical Systems Corp. in the FDA's device registry (GUDID). Together they are named in 5,217 adverse event reports in the FDA's MAUDE database, received between Aug 11, 2020 and Sep 30, 2026 — classified as 2 injuries, 5,215 malfunctions.
The most frequently reported specific device problem is “No Display/Image” (1,687 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported HD CAMERA HEAD problems
Device problems
- No Display/Image1,687
- Poor Quality Image1,397
- Material Split, Cut or Torn339
- Leak/Splash291
- Communication or Transmission Problem248
- Break243
- Erratic or Intermittent Display170
- Detachment of Device or Device Component168
Patient problems
- No Clinical Signs, Symptoms or Conditions5,198
- No Patient Involvement9
- No Consequences Or Impact To Patient6
- Insufficient Information4
HD CAMERA HEAD models
2 models, most reported first. Each model has its own page with its reports, recalls and device details.
- HD CAMERA HEAD OLYMPUS CH-S190-08-LBEndoscope, accessories, narrow band spectrum3,793 reports
- HD CAMERA HEAD OTV-S7ProH-HD-L08EEndoscopic video imaging system/component, gastroenterology-urology1,424 reports
Recent HD CAMERA HEAD adverse event reports
The 15 most recent reports across all models, 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 28, 2026Loose or Intermittent Connection; Poor Quality Image
The customer reported that the lock was wobbly and swiveling during reprocessing of an Olympus camera head. During the initial evaluation of the device, purple lines were observed on the image. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50923183 ↗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, 2026Gas/Air Leak
The customer returned the camera head, which is an Olympus asset with no reported complaint. 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 50885327 ↗
Other Olympus Medical Systems Corp. products
- EVIS EXERA lll COLONOVIDEOSCOPE16 models · 15,013 reports · 7 recalls
- EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE7 models · 13,448 reports · 7 recalls
- EVIS EXERA II ULTRASOUND GASTROVIDEOSCOPE9 models · 8,317 reports · 2 recalls
- EVIS EXERA III BRONCHOVIDEOSCOPE11 models · 6,060 reports · 16 recalls
- EVIS EXERA III XENON LIGHT SOURCE2 models · 6,694 reports
- EVIS EXERA III COLONOVIDEOSCOPE6 models · 6,117 reports · 5 recalls
- EVIS EXERA III DUODENOVIDEOSCOPE OLYMPUS TJF-Q190V2 models · 5,281 reports · 4 recalls
- 4K CAMERA HEAD3 models · 4,926 reports
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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