VISERA VIDEO SYSTEM CENTER OTV-S7V CAMERA HEAD OTV-S7H-1D-F08ERecalls & reported problems
Olympus Medical Systems Corp. · "OTV-S7H-1D-F08E Camera Head, beamsplit" · Class 2
All models of VISERA VIDEO SYSTEM CENTER OTV-S7V CAMERA HEAD (6)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This Olympus VISERA camera head for laparoscopes has 393 reports in the FDA database, with no deaths and 1 injury. The reports often describe no display or image, poor image quality, corrosion, and fluid or gas leaks. Reports fell to 4 in the last 12 months from 29 in the 12 months before. 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
- 394
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 394 adverse event reports that list this exact device (DI 04953170142246), received between Oct 3, 2019 and Sep 30, 2026 — classified as 1 injury, 393 malfunctions.
The most frequently reported specific device problem is “No Display/Image” (167 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
- No Display/Image167
- Poor Quality Image111
- Corroded32
- Gas/Air Leak20
- Leak/Splash20
- Break19
- Erratic or Intermittent Display16
- Material Split, Cut or Torn15
Patient problems
- No Clinical Signs, Symptoms or Conditions392
- No Consequences Or Impact To Patient2
Recent adverse event reports
The 25 most recent of 394 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 2026Misfocusing
The customer reported the Camera Head image was blurry during maintenance. During the initial evaluation of the device image interference was observed. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50941806 ↗MalfunctionJun 23, 2026Corroded; Poor Quality Image; Gas/Air Leak; Output Problem
THE CUSTOMER RETURNED THE CAMERA HEAD, WHICH IS AN OLYMPUS ASSET WITH NO REPORTED COMPLAINT. DURING THE EVALUATION OF THE DEVICE, NOT FUNCTIONING PROPERLY, ABNORMALITIES IN IMAGE COLOR OR BRIGHTNESS WERE OBSERVED, WITH NOISE, DROPOUTS, OR DISTORTION AFFECTING PROPER VISUALIZATION, LEAKAGE WAS DETECTED, DAMAGE, DEFORMATION, OR CORROSION AT THE CONNECTION AREA WAS OBSERVED. THE SERVICE REPAIR TECHNICIAN INDICATED THAT THE MOST LIKELY CAUSE OF THE NOT FUNCTIONING PROPERLY, ABNORMALITIES IN IMAGE COLOR OR BRIGHTNESS WERE OBSERVED, WITH NOISE, DROPOUTS, OR DISTORTION AFFECTING PROPER VISUALIZATION, LEAKAGE WAS DETECTED, DAMAGE, DEFORMATION, OR CORROSION AT THE CONNECTION AREA WAS DUE TO COMPONENT FAILURE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25598870 ↗MalfunctionMar 20, 2026Material Split, Cut or Torn
IT WAS REPORTED THAT THE CAMERA HEAD HAD THE SKINNY PART OF THE CORD THAT PLUGS INTO THE TOWER WITH A SPLIT IN THE COATING THAT GOES AROUND THE WIRES. THE ISSUE WAS FOUND DURING REPROCESSING. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24647759 ↗MalfunctionNov 24, 2025No Display/Image; No Display/Image
NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23640103 ↗MalfunctionNov 24, 2025No Display/Image; No Display/Image
NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23640081 ↗MalfunctionOct 15, 2025Poor Quality Image; Poor Quality Image
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE SUBJECT DEVICE EXHIBITED IMAGE ANOMALY. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23290705 ↗MalfunctionFeb 25, 2025Break; Break
NO ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21460979 ↗MalfunctionFeb 13, 2025Break; Scratched Material; Break; Scratched Material
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE SUBJECT DEVICE EXHIBITED A FILM BREAK (BURN) ON THE CAMERA CABLE, AND A SCRATCH ON THE LENS OF THE MAIN BODY. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21375712 ↗MalfunctionFeb 13, 2025Corroded; Corroded
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE CAMERA HEAD EXHIBITED CORROSION ON THE ELECTRICAL CONTACTS. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21374386 ↗MalfunctionFeb 11, 2025Poor Quality Image; Defective Component; Poor Quality Image; Defective Component
IT WAS REPORTED THAT THE SUBJECT DEVICE HAD POOR IMAGE QUALITY AND CONNECTOR SECTION DEFECTIVE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21360912 ↗MalfunctionJan 27, 2025Loose or Intermittent Connection; Loose or Intermittent Connection
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE CAMERA HEAD EXHIBITED A COUPLER THAT IS LOOSE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21244578 ↗MalfunctionJan 23, 2025Poor Quality Image; Poor Quality Image
NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21223823 ↗MalfunctionJan 15, 2025No Display/Image; No Display/Image
IT WAS REPORTED THE SUBJECT DEVICE DOES NOT DISPLAY IMAGE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21162521 ↗MalfunctionJan 10, 2025Leak/Splash; Material Split, Cut or Torn; Leak/Splash; Material Split, Cut or Torn
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE SUBJECT DEVICE EXHIBITED THE FOLLOWING: THERE WAS WATER-TIGHTNESS FAILURE OF THE CABLE AND THE CABLE WAS BUCKLING AND SCRATCHED. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21129456 ↗MalfunctionJan 3, 2025No Display/Image; No Display/Image
IT WAS REPORTED THAT THE SUBJECT DEVICE HAD NO IMAGE. THE ISSUE WAS FOUND DURING SET UP OF THE DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21067490 ↗MalfunctionDec 30, 2024Break; Degraded; Leak/Splash; Poor Quality Image; Noise, Audible; Break; Degraded; Leak/Splash; Poor Quality Image; Noise, Audible
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE CAMERA HEAD EXHIBITED IMAGE FLICKERING, WATER TIGHTNESS LOST AND DAMAGE TO THE UNIT ITSELF, ALSO THE COUPLER EXPERIENCED RATTLES AND THE CABLE IS CRACKED. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21038838 ↗MalfunctionDec 27, 2024Leak/Splash; Leak/Splash
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE SUBJECT DEVICE EXHIBITED POOR WATER TIGHTNESS. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21029580 ↗MalfunctionDec 10, 2024Degraded; No Display/Image; Material Deformation; Material Integrity Problem; Material Split, Cut or Torn; Degraded; No Display/Image; Material Deformation; Material Integrity Problem; Material Split, Cut or Torn
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE SUBJECT DEVICE EXHIBITED A DETERIORATED ADAPTER. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20894900 ↗MalfunctionDec 10, 2024Poor Quality Image; Poor Quality Image
NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20893752 ↗MalfunctionDec 10, 2024Crack; Crack
IT WAS REPORTED THAT THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20893561 ↗MalfunctionDec 10, 2024Break; No Display/Image; Break; No Display/Image
IT WAS REPORTED THAT THE SUBJECT DEVICE HAD A FLICKERING IMAGE AND A BROKEN CABLE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20891799 ↗MalfunctionDec 9, 2024Poor Quality Image; Poor Quality Image
NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20878962 ↗MalfunctionDec 9, 2024No Display/Image; No Display/Image
NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20878023 ↗MalfunctionDec 6, 2024Corroded; Fluid/Blood Leak; Corroded; Fluid/Blood Leak
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THAT THE SUBJECT DEVICE EXHIBITED ELECTRICAL CONTACT CORROSION AND MAIN BODY FLOODING. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20863551 ↗MalfunctionDec 5, 2024Crack; Detachment of Device or Device Component; Crack; Detachment of Device or Device Component
IT WAS REPORTED THE CAMERA HEAD RUBBER PART HAD A CRACK AND CAME OFF. THE ISSUE OCCURRED DURING PREPARATION FOR USE OF AN UNSPECIFIED THERAPEUTIC PROCEDURE BEFORE ADMINISTERING ANESTHESIA WHICH WAS COMPLETED USING THE SAME DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20855804 ↗
Other Laparoscope, general & plastic surgery devices
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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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