VISERA VIDEO SYSTEM CENTER OTV-S7V CAMERA HEAD OTV-S7H-1D-L08E (UDI 04953170142222)Recalls & reported problems
Olympus Medical Systems Corp. · 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 is used in laparoscopic surgery. Its 563 reports mostly describe no display or image, poor image quality, breaks and leaks, and most list no clinical signs or conditions in the patient. The reports include no deaths and no injuries. 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
- 578
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 578 adverse event reports that list this exact device (DI 04953170142222), received between Sep 28, 2018 and Sep 30, 2026 — classified as 578 malfunctions.
The most frequently reported specific device problem is “No Display/Image” (291 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/Image291
- Poor Quality Image114
- Break53
- Erratic or Intermittent Display34
- Leak/Splash32
- Material Split, Cut or Torn28
- Display or Visual Feedback Problem20
- Connection Problem16
Patient problems
- No Clinical Signs, Symptoms or Conditions570
- Insufficient Information5
- No Consequences Or Impact To Patient2
- No Known Impact Or Consequence To Patient1
- No Patient Involvement1
Recent adverse event reports
The 25 most recent of 578 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 2026No Display/Image
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50954729 ↗MalfunctionSep 30, 2026Display or Visual Feedback Problem; Loose or Intermittent Connection
The customer reported camera out of service and false contact during inspection for use involving an Olympus Camera Head. There was no patient involvement reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50947137 ↗MalfunctionSep 29, 2026Erratic or Intermittent Display; Loose or Intermittent Connection
The customer reported a disruption in the signal and had to wiggle the wiring to get a stable image involving an Olympus Camera Head. There was no patient involvement reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50937003 ↗MalfunctionSep 29, 2026Loose or Intermittent Connection; Poor Quality Image
The customer reported Disruption in the signal. Have to wiggle the wiring to get a stable image, involving an Olympus Camera head. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50934564 ↗MalfunctionSep 21, 2026Poor Quality Image; Failure to Clean Adequately
The customer reported the camera head had insufficient illumination while automatic light control was active and deposits were also found on the electrical contacts during reprocessing. No patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50835064 ↗MalfunctionSep 17, 2026Loose or Intermittent Connection
The customer reported a fake and poor electrical contact at the cable level involving an Olympus camera head. There was no patient injury reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50809165 ↗MalfunctionSep 17, 2026Loose or Intermittent Connection; Poor Quality Image
The customer reported that lose connection in cable and resulting in intermittent image involving an Olympus camera head. There was no patient injury reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50805495 ↗MalfunctionSep 15, 2026Poor Quality Image; Gas/Air Leak
The customer reported the camera head had half of image was obscured during an unknown procedure. The procedure was completed using the same device. During the initial evaluation of the device, it was observed cable was leaking. No patient harm was reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50774179 ↗MalfunctionSep 14, 2026Loose or Intermittent Connection
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50747972 ↗MalfunctionSep 9, 2026Optical Decentration
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50699311 ↗MalfunctionSep 9, 2026Material Separation; Gas/Air Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50692420 ↗MalfunctionSep 8, 2026No Display/Image; Poor Quality Image
The customer reported black or distorted image involving an Olympus camera head. There was no patient injury reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50669038 ↗MalfunctionSep 8, 2026Disconnection; No Display/Image; Display or Visual Feedback Problem
The customer reported image static with interference during inspection for use involving an Olympus Camera Head. Additionally, during the initial evaluation, disconnection of the cable unit and no image were observed. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50668170 ↗MalfunctionSep 7, 2026No Display/Image; Poor Quality Image
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50657657 ↗MalfunctionSep 4, 2026No Display/Image
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50622724 ↗MalfunctionSep 2, 2026Erratic or Intermittent Display
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50572361 ↗MalfunctionAug 28, 2026Gas/Air Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50503350 ↗MalfunctionAug 18, 2026No Display/Image
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50304893 ↗MalfunctionAug 17, 2026Gas/Air Leak
The customer returned the camera head to the service center for evaluation related to a separate issue. During inspection, the Service Repair Technician identified that the device had water tightness loss. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50279616 ↗MalfunctionAug 12, 2026Display or Visual Feedback Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50217625 ↗MalfunctionAug 11, 2026No Display/Image; Loose or Intermittent Connection; Poor Quality Image
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50207361 ↗MalfunctionAug 11, 2026No Display/Image; Loose or Intermittent Connection
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50207317 ↗MalfunctionAug 10, 2026No Display/Image; Output Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50194911 ↗MalfunctionAug 7, 2026Image Display Error/Artifact
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50177699 ↗MalfunctionAug 7, 2026No Display/Image; Leak/Splash; Loose or Intermittent Connection; Poor Quality Image; Material Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50174924 ↗
Other Laparoscope, general & plastic surgery devices
- HIGH DEFINITION LCD MONITOR OEV262HOlympus Medical Systems Corp. · Laparoscope, general & plastic surgery1,937 reports
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- HD AUTOCLAVABLE CAMERA HEAD OTV-S7ProH-HD-10EOlympus Medical Systems Corp. · Laparoscope, general & plastic surgery1,086 reports
- Auto Suture OMS-T10BTCovidien LP · Laparoscope, general & plastic surgery1 recall955 reports
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- VISERA 4K UHD CAMERA CONTROL UNIT OLYMPUS OTV-S400Olympus Medical Systems Corp. · Laparoscope, general & plastic surgery777 reports
- Auto Suture OMS-T10SBCovidien LP · Laparoscope, general & plastic surgery1 recall697 reports
- Spacemaker SMBTTRNDXCovidien LP · Laparoscope, general & plastic surgery590 reports
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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