Micro-G™ Otology KitRecalls & reported problems
Lumenis Ltd. · Class 2
Data updated Oct 13, 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 07290109142074), received between Mar 26, 2023 and Mar 26, 2023 — classified as 1 malfunction.
The most frequently reported specific device problem is “Defective 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. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Defective 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.
MalfunctionMar 26, 2023Defective Device; Defective Device
IT WAS REPORTED THAT DURING A STAPES PROCEDURE, THE AIMING BEAM COULD NOT BE SEEN THOUGH THE DEVICE. THE PROCEDURE NEEDED TO BE RESCHEDULED. THERE WAS NO REPORTED PERMANENT IMPAIRMENT OR INJURY TO THE PATIENT. THE CONSOLE WAS TESTED ACCORDING TO THE IFU PRIOR TO THE SEDATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16616886 ↗
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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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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