CAMERA HEADRecalls & reported problems across all models
Olympus Medical Systems Corp. · 2 models in the FDA device registry
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 244
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls
- 0
We found 2 models of CAMERA HEAD by Olympus Medical Systems Corp. in the FDA's device registry (GUDID). Together they are named in 244 adverse event reports in the FDA's MAUDE database, received between Jan 7, 2021 and Aug 13, 2025 — classified as 244 malfunctions.
The most frequently reported specific device problem is “No Display/Image” (112 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 CAMERA HEAD problems
Device problems
- No Display/Image112
- Poor Quality Image57
- Leak/Splash14
- Material Split, Cut or Torn10
- Corroded9
- Crack9
- Disconnection9
- Break8
Patient problems
- No Clinical Signs, Symptoms or Conditions241
- No Consequences Or Impact To Patient3
- Insufficient Information1
- No Patient Involvement1
CAMERA HEAD models
2 models, most reported first. Each model has its own page with its reports, recalls and device details.
- CAMERA HEAD OTV-S7H-1D-L08ELaparoscope, general & plastic surgery182 reports
- CAMERA HEAD MAJ-554Laparoscope, general & plastic surgery62 reports
Recent CAMERA HEAD adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionAug 13, 2025Poor Quality Image; Poor Quality Image
IT WAS REPORTED THAT THE CAMERA HEAD HAD POOR IMAGE QUALITY. THE ISSUE WAS FOUND DURING A SETTING UP THE DEVICE BEFORE PATIENT WAS INSIDE THE ROOM. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22795272 ↗MalfunctionJul 28, 2025No Display/Image; No Display/Image
IT WAS REPORTED THE SUBJECT DEVICE HAD NO VIDEO IMAGE OUTPUT. THE EVENT OCCURRED DURING REPROCESSING. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22632591 ↗MalfunctionMay 27, 2025Poor Quality Image; Communication or Transmission Problem; Poor Quality Image; Communication or Transmission Problem
IT WAS REPORTED THAT THE CAMERA HEAD WAS NOT WORKING AND HAD NOISY IMAGE, BUT SUBJECT COULD BE RECOGNIZED. THE EVENT OCCURRED AT SERVICE/MAINTENANCE. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22093308 ↗MalfunctionMay 7, 2025Poor Quality Image; Poor Quality Image
IT WAS REPORTED THE CAMERA HEAD EXPERIENCED A CLARITY ISSUE. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21978470 ↗MalfunctionApr 25, 2025Break; Break
NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21907138 ↗MalfunctionFeb 5, 2025Poor Quality Image; Poor Quality Image
IT WAS REPORTED THAT THE SUBJECT DEVICE HAD ABNORMAL IMAGE. THE ISSUE OCCURRED DURING OUT OF THE BOX FAILURE. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21314658 ↗MalfunctionFeb 3, 2025Poor Quality Image; Poor Quality Image
IT WAS REPORTED THAT THE SUBJECT DEVICE HAD AN ABNORMAL IMAGE. THE EVENT OCCURRED DURING REPROCESSING. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21294333 ↗MalfunctionJan 21, 2025Leak/Splash; Leak/Splash
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE SUBJECT DEVICE EXHIBITED A FAILED LEAK TEST. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21200356 ↗MalfunctionJan 13, 2025Gas/Air Leak; Gas/Air Leak
IT WAS OBSERVED DURING THE DEVICE EVALUATION THAT THE SCOPE MOUNT AND THE IMAGING SYSTEM OF THE SUBJECTED DEVICE WERE FLOODED. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21146392 ↗MalfunctionJan 7, 2025Corroded; Leak/Splash; Material Deformation; Corroded; Leak/Splash; Material Deformation
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE SUBJECT DEVICE EXHIBITED WATER TIGHTNESS IS LOST, ELECTRICAL CONTACT WAS CORRODED AND CABLE HAD DEFORMATION. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21093076 ↗MalfunctionJan 7, 2025Poor Quality Image; Poor Quality Image
IT WAS REPORTED THAT THE SUBJECTED DEVICE EXHIBITED A NOISY IMAGE. THE ISSUE WAS FOUND DURING MAINTENANCE. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21093000 ↗MalfunctionDec 29, 2024Erratic or Intermittent Display; Erratic or Intermittent Display
IT WAS REPORTED THE SUBJECT DEVICE HAD NOISY IMAGE (INTERMITTENTLY) AND THE OBJECTS COULD NOT BE RECOGNIZED. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21032282 ↗MalfunctionDec 6, 2024Poor Quality Image; Poor Quality Image
IT WAS REPORTED THAT THE SUBJECT DEVICE HAD AN ABNORMAL IMAGE THAT WAS SOMETIMES DISTURBED BY STREAKS. THE EVENT OCCURRED DURING REPROCESSING. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20863703 ↗MalfunctionNov 20, 2024Electrical /Electronic Property Problem; Poor Quality Image; Material Split, Cut or Torn; Electrical /Electronic Property Problem; Poor Quality Image; Material Split, Cut or Torn
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE SUBJECT DEVICE EXHIBITED CUT ON CABLE METAL SHEATH, POOR COLOR IMAGE AND FAULTY CHARGE-COUPLED DEVICE (CCD). THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20740671 ↗MalfunctionNov 12, 2024Erratic or Intermittent Display; Erratic or Intermittent Display
IT WAS REPORTED THE CAMERA HEAD HAD A NOISY IMAGE. THE MALFUNCTION WAS IDENTIFIED DURING ROUTINE INSPECTION. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20662854 ↗
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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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