HD AUTOCLAVABLE CAMERA HEADRecalls & reported problems across all models
Olympus Medical Systems Corp. · 6 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4,455
- Deaths reported
- 0
- Injuries reported
- 6
- Recalls
- 0
We found 6 models of HD AUTOCLAVABLE CAMERA HEAD by Olympus Medical Systems Corp. in the FDA's device registry (GUDID). Together they are named in 4,455 adverse event reports in the FDA's MAUDE database, received between Jun 5, 2019 and Sep 30, 2026 — classified as 6 injuries, 4,449 malfunctions.
The most frequently reported specific device problem is “No Display/Image” (1,915 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 AUTOCLAVABLE CAMERA HEAD problems
Device problems
- No Display/Image1,915
- Poor Quality Image1,212
- Erratic or Intermittent Display247
- Communication or Transmission Problem231
- Material Split, Cut or Torn193
- Break179
- Leak/Splash153
- Display or Visual Feedback Problem100
Patient problems
- No Clinical Signs, Symptoms or Conditions4,320
- No Patient Involvement76
- No Consequences Or Impact To Patient59
- Insufficient Information10
- No Information1
- No Known Impact Or Consequence To Patient1
HD AUTOCLAVABLE CAMERA HEAD models
6 models, most reported first. Each model has its own page with its reports, recalls and device details.
- HD AUTOCLAVABLE CAMERA HEAD OTV-S7ProH-HD-12ELaparoscope, general & plastic surgery1,886 reports
- HD AUTOCLAVABLE CAMERA HEAD OLYMPUS CH-S190-XZ-EEndoscope, accessories, narrow band spectrum1,424 reports
- HD AUTOCLAVABLE CAMERA HEAD OTV-S7ProH-HD-10ELaparoscope, general & plastic surgery1,086 reports
- HD AUTOCLAVABLE CAMERA HEAD OLYMPUS CH-S190-XZ-QEndoscope, accessories, narrow band spectrum26 reports
- HD AUTOCLAVABLE CAMERA HEAD OTV-S7ProH-HD-12QLaparoscope, general & plastic surgery23 reports
- HD AUTOCLAVABLE CAMERA HEAD OTV-S7ProH-HD-10QLaparoscope, general & plastic surgery10 reports
Recent HD AUTOCLAVABLE 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, 2026Leak/Splash; Poor Quality Image
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50954947 ↗MalfunctionSep 30, 2026Poor Quality Image
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50952628 ↗MalfunctionSep 30, 2026No Display/Image
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50949906 ↗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 50935668 ↗MalfunctionSep 29, 2026Poor Quality Image; Gas/Air Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50935452 ↗MalfunctionSep 29, 2026Erratic or Intermittent Display; Gas/Air Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50934342 ↗MalfunctionSep 29, 2026Electrical /Electronic Property Problem; Poor Quality Image
The customer reported the camera head had a static that will not clear during reprocessing. During the initial evaluation of the device, it was observed that it was due to a faulty cable. There were no reports of patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50934110 ↗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, 2026Poor Quality Image
The customer reported poor 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 50856420 ↗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 21, 2026Poor Quality Image; Material Split, Cut or Torn
The customer reported crack on the screen during reprocessing involving an Olympus camera head. During initial evaluation it was observer, one lines on the screen. There were no reports of patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50843129 ↗MalfunctionSep 18, 2026Gas/Air Leak
The customer returned the Camera Head, which is an Olympus asset with no reported complaint. During the evaluation of the device, a failed leak test was observed. The Service Repair Technician indicated that the most likely cause of the failed leak test was component failure. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50817451 ↗MalfunctionSep 17, 2026No Display/Image
The customer reported black screen, no picture during an unknown event using an Olympus camera head. There was no patient harm reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50797585 ↗
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
- HD CAMERA HEAD2 models · 5,217 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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