BOVIE 0010Recalls & reported problems
Aspen Surgical Products, Inc. · Burr, Ophthalmic II, Power Handle · Class 1
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 10607151000100), received between Jun 16, 2021 and Jun 16, 2021 — classified as 1 malfunction.
The most frequently reported specific device problem is “Key or Button Unresponsive/not Working” (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
- Key or Button Unresponsive/not Working1
- Output Problem1
Patient problems
- Insufficient Information1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 16, 2021Output Problem; Key or Button Unresponsive/not Working
THE CUSTOMER ALLEGED THAT THE DOCTOR ATTEMPTED TO USE THE DEVICE ON A PATIENT, BUT IT STOPPED WORKING SECONDS AFTER THE BUTTON WAS PUSHED. THERE WAS NO DELAY IN TREATMENT AND THERE WAS NO HARM TO THE PATIENT
Patient problems: Insufficient Information
MAUDE report 12009162 ↗
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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