BOVIE A1204P (UDI 10607151001428)Recalls & reported problems
Aspen Surgical Products, Inc. · GROUNDING PLATE; REUSABLE · Class 2
All models of Bovie (42)
Data updated Oct 16, 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 10607151001428), received between Mar 12, 2020 and Mar 12, 2020 — classified as 1 malfunction.
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.
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Burn, Thermal1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 12, 2020Adverse Event Without Identified Device or Use Problem
THE PATIENT WAS INJURED THE FIRST TIME THE ACCESSORIES WERE USED DURING A LEEP PROCEDURE. THE GROUNDING PAD CAUSED A BURN ON THE PATIENT. THERE WAS NO PERMANANT DAMAGE OR SERIOUS INJURY TO THE PATIENT.
Patient problems: Burn, Thermal
MAUDE report 9825641 ↗
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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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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