VISERA VIDEO SYSTEM CENTER OTV-S7V CAMERA HEAD OTV-S7H-1D-L08E (UDI 04953170142215)Recalls & reported problems
Olympus Medical Systems Corp. · "OTV-S7H-1D-L08E SD URO Camera, Pendulum" · 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 the camera part of a video system used in laparoscopic surgery. All 355 reports are malfunctions, with no injuries and no deaths; the most common problems are no image on the display (156 reports) and poor image quality (71). No patient symptoms are recorded in 353 of them. There are no recalls naming 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
- 358
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 358 adverse event reports that list this exact device (DI 04953170142215), received between Oct 22, 2020 and Sep 21, 2026 — classified as 358 malfunctions.
The most frequently reported specific device problem is “No Display/Image” (157 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/Image157
- Poor Quality Image71
- Material Split, Cut or Torn41
- Break11
- Erratic or Intermittent Display11
- Disconnection9
- Leak/Splash9
- Display or Visual Feedback Problem8
Patient problems
- No Clinical Signs, Symptoms or Conditions356
- No Patient Involvement2
Recent adverse event reports
The 25 most recent of 358 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 21, 2026Degraded; No Display/Image
The customer reported the camera head has no image. During initial evaluation of the device, it was observed Electrical SYS kinks and damage cable insulation.There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50841501 ↗MalfunctionSep 14, 2026Gas/Air Leak
The customer returned the camera head for a separate issue. During the initial evaluation of the returned device, failed leak test was found. No patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50757419 ↗MalfunctionSep 8, 2026Moisture Damage; Material Split, Cut or Torn
The customer reported the camera head cable is exposed. during reprocessing. During the initial evaluation of the device, it was observed that moisture on the lens. No patient involvement was reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50665713 ↗MalfunctionAug 31, 2026Material Split, Cut or Torn
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50533004 ↗MalfunctionAug 12, 2026Degraded
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50217743 ↗MalfunctionAug 12, 2026Degraded
The customer reported bunched-up wires 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 50217662 ↗MalfunctionAug 11, 2026No Display/Image
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50209190 ↗MalfunctionAug 5, 2026Material Split, Cut or Torn
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50145839 ↗MalfunctionAug 5, 2026No Display/Image
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50145669 ↗MalfunctionJul 28, 2026Gas/Air Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50057661 ↗MalfunctionJul 27, 2026No Display/Image; Poor Quality Image
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50024790 ↗MalfunctionJul 20, 2026No Display/Image
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25873859 ↗MalfunctionJun 29, 2026No Display/Image
THE CUSTOMER REPORTED NO IMAGE ON SCREEN DURING INSPECTION FOR USE INVOLVING AN OLYMPUS CAMERA HEAD. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25653892 ↗MalfunctionJun 26, 2026No Display/Image
THE CUSTOMER RETURNED THE CAMERA HEAD TO THE SERVICE CENTER FOR EVALUATION WITH NO CUSTOMER ALLEGATION. DURING TESTING, THE FIELD SERVICE ENGINEER IDENTIFIED THE DEVICE HAD NO IMAGE DUE TO FAULTY CHARGED COUPLED DEVICE AND LEAKAGE. THERE WAS NO PATIENT INVOLVEMENT. ¿
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25638271 ↗MalfunctionJun 11, 2026No Display/Image
THE CUSTOMER REPORTED NO IMAGE WHEN THE CAMERA HEAD WAS PLUGGED 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 25478123 ↗MalfunctionJun 10, 2026Leak/Splash
THE CUSTOMER RETURNED THE CAMERA HEAD TO THE SERVICE CENTER WHICH IS AN OLYMPUS ASSET WITH NO REPORTED COMPLAINT. DURING THE DEVICE ANALYSIS, THE SERVICE REPAIR TECHNICIAN INDICATED FAILED LEAK TEST. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25456551 ↗MalfunctionJun 8, 2026Gas/Air Leak
THE CUSTOMER RETURNED THE CAMERA HEAD TO THE SERVICE CENTER FOR A SPOT IN IMAGE. DURING THE DEVICE ANALYSIS, THE SERVICE CENTER TECHNICIAN INDICATES THAT A LEAK AT CABLE WAS FOUND. IT WAS DETERMINED THAT THE CABLE NEEDED TO BE REPLACED. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25430516 ↗MalfunctionJun 6, 2026No Display/Image
THE CUSTOMER REPORTED NO IMAGE DURING REPROCESSING INVOLVING AN OLYMPUS CAMERA HEAD. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25420625 ↗MalfunctionJun 6, 2026No Display/Image
THE CUSTOMER REPORTED NO PICTURE SHOWING DURING INSPECTION FOR USE INVOLVING AN OLYMPUS CAMERA HEAD. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25420576 ↗MalfunctionJun 6, 2026Poor Quality Image
THE CUSTOMER REPORTED CLOUDY IMAGE DURING REPROCESSING INVOLVING AN OLYMPUS CAMERA HEAD. THERE WAS NO PATIENT INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25419510 ↗MalfunctionMay 28, 2026Circuit Failure; No Display/Image; Material Split, Cut or Torn
THE CUSTOMER RETURNED THE CAMERA HEAD THE SERVICE CENTER FOR EVALUATION RELATED TO A SEPARATE ISSUE. DURING TESTING, THE SERVICE CENTER IDENTIFIED THE DEVICE HAD NO IMAGE, FAULTY CHARGED COUPLED DEVICE (CCD) AND CUT ON CABLE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25323143 ↗MalfunctionMay 25, 2026Erratic or Intermittent Display
IT WAS REPORTED THAT THE CAMERA HEAD HAD IMAGE WENT IN AND OUT. THE EVENT OCCURRED DURING REPROCESSING. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25272280 ↗MalfunctionMay 24, 2026No Display/Image
THE CUSTOMER REPORTED THAT WHEN THE DEVICE WAS PLUGGED IN, THE SCREEN WAS BLACK AND SHOWED NO IMAGE DURING INSPECTION FOR USE INVOLVING AN OLYMPUS CAMERA HEAD. THERE WAS NO PATIENT INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25267142 ↗MalfunctionMay 24, 2026Material Protrusion/Extrusion
THE CUSTOMER REPORTED SHOWING WIRE DURING REPROCESSING INVOLVING AN OLYMPUS CAMERA HEAD. THERE WAS NO PATIENT INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25267052 ↗MalfunctionMay 24, 2026Poor Quality Image
THE CUSTOMER REPORTED BAD IMAGE DURING REPROCESSING INVOLVING AN OLYMPUS CAMERA HEAD. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25266991 ↗
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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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