VS3-IR 153-0072Recalls & reported problems
Visionsense Ltd. · VS3 Iridium Endoscope-IR 10mm, Long, 30°, Standard FOV · Class 2
All models of VS3-IR (6)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 18130400103649), received between Aug 22, 2022 and Aug 22, 2022 — classified as 1 malfunction.
The most frequently reported specific device problem is “Overheating of Device” (1 report).
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.
Most reported problems
Device problems
- Overheating of Device1
- Smoking1
- Thermal Decomposition of Device1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 22, 2022Thermal Decomposition of Device; Overheating of Device; Smoking; Thermal Decomposition of Device; Overheating of Device; Smoking
DURING THE BEGINNING OF THE PROCEDURE THE DEVICE WAS WORKING WELL. HOWEVER, AFTER SOME TIME, THE SCOPE BECAME HOTTER AND THE SCOPE FIBER CABLES BEGAN TO BURN AND PRODUCED SMOKE. THERE WAS APPROXIMATELY A 5-10 MINUTE DELAY IN THE PROCEDURE WHILE THE TEAM SWITCHED OUT THE LAP TOWER AND SCOPE FOR ANOTHER ONE. THE OPERATION WAS CARRIED OUT NORMALLY AND THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15271947 ↗
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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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