VS3-IR 174-0012 (UDI 18130400103489)Recalls & reported problems
Visionsense Ltd. · VS3 Iridium - Miniature Microscope (MMS-IR) · Class 2
All models of VS3-IR (6)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 18130400103489), received between Apr 14, 2023 and Apr 14, 2023 — classified as 1 malfunction.
The most frequently reported specific device problem is “Material Integrity Problem” (1 report).
1 FDA recall record name this device's identifier, 1 still open.
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 16, 2026.
Recalls naming this device
- Oct 17, 2022Open, Classified
Broken Optical fiber cable damage can occur through handling or bending and can lead to loss of functionality and heating/melting of the outer cable surface.
Z-0280-2023 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
Most reported problems
Device problems
- Material Integrity Problem1
- 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.
MalfunctionApr 14, 2023Thermal Decomposition of Device; Material Integrity Problem; Thermal Decomposition of Device; Material Integrity Problem
ACCORDING TO THE REPORTER, PRIOR TO USE, THE DEVICE LASER LIGHT SOURCE TURNED ON DURING REGULAR EQUIPMENT TESTS AND THE DAMAGE TO THE CABLE WAS NOTICED. IT WAS ALSO DISPLAYED ON THE ATTACHED VIDEO AND IMAGE. THE AGE OF THE SYSTEM WAS APPROXIMATELY ONE YEAR AGO. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16743448 ↗
Other Endoscope, Neurological devices
- AESCULAP FF399RAesculap AG · ENDOSCOPE, NEUROLOGICAL2 recalls0 reports
- VS3-IR 161-0001Visionsense Ltd. · Endoscope, Neurological1 recall4 reports
- Aurora® Surgiscope® ASX9/130Integra Lifesciences Corporation · Endoscope, neurological1 recall0 reports
- IMAGE1 S CONNECT TC201USKarl Storz GmbH & Co. KG · Endoscope, neurological34 reports
- Artemis AP28-APenumbra, Inc. · Endoscope, Neurological4 deaths31 reports
- NA 1688410105Stryker Corporation · Endoscope, neurological24 reports
- Apollo System AP9Penumbra, Inc. · ENDOSCOPE, NEUROLOGICAL10 reports
- NA 1688410110Stryker Corporation · Endoscope, neurological8 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 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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