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
- 181
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls
- 0
We found 6 models of AUTOCLAVABLE CAMERA HEAD by Olympus Medical Systems Corp. in the FDA's device registry (GUDID). Together they are named in 181 adverse event reports in the FDA's MAUDE database, received between Oct 1, 2020 and Jun 16, 2026 — classified as 181 malfunctions.
The most frequently reported specific device problem is “Poor Quality Image” (65 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 AUTOCLAVABLE CAMERA HEAD problems
Device problems
- Poor Quality Image65
- No Display/Image62
- Loose or Intermittent Connection12
- Erratic or Intermittent Display10
- Leak/Splash7
- Break6
- Material Split, Cut or Torn6
- Corroded5
Patient problems
- No Clinical Signs, Symptoms or Conditions177
- No Consequences Or Impact To Patient3
- No Patient Involvement1
AUTOCLAVABLE CAMERA HEAD models
6 models, most reported first. Each model has its own page with its reports, recalls and device details.
- AUTOCLAVABLE CAMERA HEAD OTV-S7H-1NA-12ELaparoscope, general & plastic surgery53 reports
- AUTOCLAVABLE CAMERA HEAD OTV-S7H-NA-12ELaparoscope, general & plastic surgery52 reports
- AUTOCLAVABLE CAMERA HEAD OTV-S7H-1NA-10ELaparoscope, General & Plastic Surgery33 reports
- AUTOCLAVABLE CAMERA HEAD OTV-S7H-NA-10ELaparoscope, General & Plastic Surgery26 reports
- AUTOCLAVABLE CAMERA HEAD OTV-S7H-1NA-10ELaparoscope, general & plastic surgery10 reports
- AUTOCLAVABLE CAMERA HEAD OTV-S7H-NALaparoscope, General & Plastic Surgery7 reports
Recent 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.
MalfunctionJun 16, 2026Poor Quality Image
THE CUSTOMER REPORTED POOR IMAGE DURING A SET UP INVOLVING AN OLYMPUS CAMERA HEAD. THERE WAS NO PATIENT INVOLVEMENT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25523279 ↗MalfunctionJun 7, 2026Loose or Intermittent Connection; Activation Problem
THE CUSTOMER REPORTED THAT CAMERA IS TAKING PICTURES WITHOUT PUSHING ANY BUTTONS AND NOT CONNECTING PROPERLY DURING A SET UP PROCEDURE INVOLVING AN OLYMPUS CAMERA HEAD. THERE WAS NO PATIENT INVOLVEMENT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25422536 ↗MalfunctionMay 15, 2026Poor Quality Image
THE CAMERA HEAD WAS RETURNED TO THE SERVICE CENTER WITH A REPORT OF A PUNCTURE IN THE CORD. THIS DOES NOT INDICATE AN MDR REPORTABLE EVENT. HOWEVER, MDR REPORTABLE FAILURE WAS FOUND DURING TESTING AT THE SERVICE CENTER. DURING INSPECTION OF THE DEVICE, LINES SHOWING ON THE IMAGE DUE TO FAULTY CHARGE COUPLED DEVICE (CCD) WERE FOUND. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25191877 ↗MalfunctionMay 7, 2026Leak/Splash; Poor Quality Image
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE CAMERA HEAD EXHIBITED ABNORMALITY IN THE IMAGE, NORMAL OBSERVATION WAS NOT POSSIBLE AND FAILED THE AIR LEAKAGE TEST. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25113550 ↗MalfunctionApr 14, 2026No Display/Image
IT WAS REPORTED THE CAMERA HEAD EXHIBITED NO IMAGE. THE ISSUE OCCURRED DURING INSPECTION FOR USE. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24877634 ↗MalfunctionJan 30, 2026Erratic or Intermittent Display
NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24223107 ↗MalfunctionDec 23, 2025Leak/Splash; Leak/Splash
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE CAMERA HEAD EXHIBITED THE DEVICE FAILED THE LEAK TEST. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23880339 ↗MalfunctionDec 10, 2025Material Separation; Material Separation
NO ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23768855 ↗MalfunctionAug 5, 2025Poor Quality Image; Poor Quality Image
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE SUBJECT DEVICE EXHIBITED DISTORTED IMAGE DUE TO FAULTY CHARGED COUPLE DEVICE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22720145 ↗MalfunctionMay 27, 2025Material Integrity Problem; Material Integrity Problem
IT WAS REPORTED THAT THE SUBJECT DEVICE HAD A NICK IN THE CORD. THE ISSUE OCCURRED DURING REPROCESSING. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22087788 ↗MalfunctionMay 7, 2025Break; Erratic or Intermittent Display; Break; Erratic or Intermittent Display
REPORTED EVENT: IMAGE FLICKERING DUE TO CAMERA HEAD CABLE DAMAGE NO DEATH, INJURY OR HARM WAS REPORTED TO OLYMPUS. THERE WAS NO PATIENT OR PROCEDURE INVOLVEMENT. NO PRODUCT RETURN TO OLYMPUS. THIS IS A SERVICE LOG TYPE OF INQUIRY. NOTE: BASED ON PRODUCT COMPLAINT FORM, THE PRODUCT MODEL IS OTV-S7-H10, BUT THE PRODUCT MODEL COULD NOT BE FOUND BOTH IN THE ITEM CODE LIST AND GLOBAL COMPLAINT HANDLING SYSTEM (GCHS). SO PRODUCT IS SELECTED AS "UNKNOWN" AND THE OPTION WITH MLA IN THE DROPDOWN ACCORDING TO TRIAGE PROCESS GUIDELINE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21980451 ↗MalfunctionMar 10, 2025No Display/Image; No Display/Image
NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21564394 ↗MalfunctionFeb 6, 2025Incomplete or Inadequate Connection; Incomplete or Inadequate Connection
IT WAS REPORTED THAT THE CAMERA HEAD CABLE HAD A SHORT IT IN AND WAS NOT WORKING PROPERLY. THE EVENT OCCURRED DURING A DIAGNOSTIC HYSTEROSCOPY PROCEDURE, AND IT WAS COMPLETED WITH THE SAME DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21328603 ↗MalfunctionDec 26, 2024No Display/Image; No Display/Image
IT WAS REPORTED THAT THE CAMERA HEAD EXHIBITED A BLACK SCREEN. THE ISSUE WAS FOUND DURING REPROCESSING. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21019271 ↗MalfunctionDec 23, 2024Display or Visual Feedback Problem; Image Orientation Incorrect; Display or Visual Feedback Problem; Image Orientation Incorrect
IT WAS REPORTED THE CAMERA HEAD IMAGE WAS DISPLACED AND THE REST WAS BLACK. THE ISSUE OCCURRED AFTER A DIAGNOSTIC UTERINE ENDOSCOPY PROCEDURE. THE PROCEDURE WAS COMPLETED WITH A SIMILAR DEVICE WITH NO DELAY. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21009367 ↗
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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