AUTOCLAVABLE CAMERA HEAD OTV-S7H-1NA-10E (UDI 04953170141836)Recalls & reported problems
Olympus Medical Systems Corp. · Class 2
All models of AUTOCLAVABLE CAMERA HEAD (6)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This Olympus autoclavable camera head is used on surgical laparoscopes to carry the video image. The 33 reports mostly describe image problems: poor or blurry pictures, flickering or lines across the screen, and units showing no image at all, plus leaks, corrosion and scratches on the body. No deaths or injuries are reported, and 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
- 33
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 33 adverse event reports that list this exact device (DI 04953170141836), received between May 4, 2022 and Jun 16, 2026 — classified as 33 malfunctions.
The most frequently reported specific device problem is “Poor Quality Image” (14 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
- Poor Quality Image14
- Erratic or Intermittent Display5
- Corroded3
- Leak/Splash3
- No Display/Image3
- Scratched Material3
- Break2
- Display or Visual Feedback Problem2
Patient problems
- No Clinical Signs, Symptoms or Conditions33
Recent adverse event reports
The 25 most recent of 33 reports, 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 ↗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 ↗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 ↗MalfunctionNov 20, 2024Corroded; Poor Quality Image; Scratched Material; Corroded; Poor Quality Image; Scratched Material
IT WAS OBSERVED, THAT DURING THE DEVICE EVALUATION. THE CAMERA HEAD EXHIBITED POOR CABLE IMAGE (NOISE), ELECTRICAL CONTACT CORROSION, FREE LOCK LEVER CORROSION AND MAIN BODY SCRATCHES (LENS). THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20736223 ↗MalfunctionOct 29, 2024Poor Quality Image; Poor Quality Image
IT WAS REPORTED, THE SUBJECT DEVICE HAD LINES APPEARING HORIZONTALLY IN THE PICTURE, WHEN THEY MOVED THE CONNECTING CABLE TOO MUCH. THE EVENT OCCURRED, DURING AN UNSPECIFIED PROCEDURE. THAT WAS COMPLETED USING THE SAME DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20557352 ↗MalfunctionOct 18, 2024Erratic or Intermittent Display; Erratic or Intermittent Display
NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20482175 ↗MalfunctionOct 17, 2024Corroded; Crack; Poor Quality Image; Scratched Material; Corroded; Crack; Poor Quality Image; Scratched Material
IT WAS OBSERVED, THAT DURING THE DEVICE EVALUATION. THE CAMERA HEAD EXHIBITED DETERIORATION IN THE MAIN UNIT IMAGING, IMAGE NOISE, CRACKS IN THE MAIN UNIT, SCRATCHES ON THE MAIN UNIT LENS AND CORROSION ON THE SCOPE MOUNT. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20473248 ↗MalfunctionOct 16, 2024Poor Quality Image; Poor Quality Image
NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20464264 ↗MalfunctionOct 9, 2024Poor Quality Image; Poor Quality Image
ADDITIONAL INFORMATION: THE INTENDED THERAPEUTIC PROCEDURE OF RIGID ENDOSCOPY WAS COMPLETED USING THE SAME SUBJECT DEVICE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20410293 ↗MalfunctionSep 5, 2024Display or Visual Feedback Problem; Leak/Splash; Loose or Intermittent Connection; Poor Quality Image; Scratched Material; Failure to Clean Adequately; Display or Visual Feedback Problem; Leak/Splash; Loose or Intermittent Connection; Poor Quality Image; Scratched Material; Failure to Clean Adequately
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE SUBJECT DEVICE EXHIBITED CAMERA CABLE WAS NOT WATERTIGHT, WATER INGRESS INTO THE CAMERA CABLE, WATER INGRESS IN THE MAIN IMAGING UNIT, CORROSION AT THE VIDEO CONNECTOR AND ELECTRICAL CONTACTS, CORROSION ON THE SCOPE MOUNT, IMAGE ABNORMALITY OCCURRED, OPTICAL AXIS OF THE SCOPE MOUNT WAS MISALIGNED, LOOSE SCOPE MOUNT AND THERE WAS ADHESION ON THE BODY. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20152417 ↗MalfunctionAug 27, 2024Poor Quality Image; Material Split, Cut or Torn; Poor Quality Image; Material Split, Cut or Torn
NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20079002 ↗MalfunctionAug 26, 2024Communication or Transmission Problem; Communication or Transmission Problem
IT WAS REPORTED THAT THE CAMERA HEAD EXHIBITED AN ERROR E315 IMAGE PROBLEM. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20071039 ↗MalfunctionAug 23, 2024Erratic or Intermittent Display; Erratic or Intermittent Display
IT WAS REPORTED THAT THE CAMERA HEAD HAD INTERMITTENT VIDEO. THE ISSUE OCCURRED DURING MAINTENANCE. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20047469 ↗MalfunctionAug 22, 2024No Display/Image; No Display/Image
IT WAS REPORTED THE SUBJECT DEVICE IMAGE DID NOT DISPLAY. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20033258 ↗MalfunctionAug 22, 2024Disconnection; Disconnection
IT WAS REPORTED THE CORD OF THE SUBJECT DEVICE DISCONNECTED. THE EQUIPMENT WAS REPLACED, AND THE PROCEDURE WAS COMPLETED. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20031900 ↗MalfunctionJun 26, 2024Poor Quality Image; Poor Quality Image
IT WAS REPORTED, THAT THE SUBJECT DEVICE HAD LINES ON SCREEN, DUE TO CABLE ISSUE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19619259 ↗MalfunctionJun 21, 2024Material Split, Cut or Torn; Material Split, Cut or Torn
IT WAS REPORTED THE CAMERA HEAD HAD A CUT IN THE CORD. IT OCCURRED DURING REPROCESSING. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19587164 ↗MalfunctionJun 19, 2024Poor Quality Image; Poor Quality Image
IT WAS REPORTED THE CAMERA HEAD SHOWED A POOR IMAGE QUALITY. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19566825 ↗MalfunctionMay 16, 2024Optical Distortion; Optical Distortion
IT WAS REPORTED THE CAMERA HEAD HAD A FUZZY EYEPIECE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19336198 ↗MalfunctionMay 13, 2024Erratic or Intermittent Display; Material Integrity Problem; Erratic or Intermittent Display; Material Integrity Problem
IT WAS REPORTED, THE CAMERA HEAD HAD A WEAK SPOT IN THE CORD THAT SHUTS OFF CAMERA. THE ISSUE OCCURRED DURING PREPARATION FOR USE ON A NASAL ENDOSCOPY DIAGNOSTIC PROCEDURE. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19299382 ↗MalfunctionMay 9, 2024Break; Break
IT WAS REPORTED THE COUPLER PINS WERE BROKEN ON THE CAMERA HEAD. IT IS UNKNOWN WHEN THE ISSUE OCCURRED. THERE WERE NO DELAYS AND THE PROCEDURE WAS COMPLETED USING A SIMILAR DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19276828 ↗MalfunctionMay 2, 2024Key or Button Unresponsive/not Working; Key or Button Unresponsive/not Working
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE SUBJECT DEVICE EXHIBITED NOISE DUE TO CABLE DISCONNECTION, CABLE FLOODING, AND CONTACT POINT CORROSION. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19235340 ↗MalfunctionApr 4, 2024Corroded; Leak/Splash; Corroded; Leak/Splash
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE CAMERA HEAD EXHIBITED CABLE FLOODING, ELECTRICAL CONTACT POINT CORROSION, AND FREE LOCK LEVER CORROSION. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19047316 ↗
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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.
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