BOVIE ES37Recalls & reported problems
Aspen Surgical Products, Inc. · MODIFIED BLADE ELECTRODE 2.75'' (6.985CM) 0.01525"' (0.039 CM) · Class 2
All models of Bovie (42)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00607151056377), received between Dec 10, 2020 and Oct 17, 2023 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Excessive Heating” (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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Excessive Heating1
- Material Fragmentation1
- Material Integrity Problem1
- Output Problem1
Patient problems
- Insufficient Information2
- Burn, Thermal1
- Superficial (First Degree) Burn1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 17, 2023Material Integrity Problem; Material Integrity Problem
THE CUSTOMER ALLEGED THAT THE PLASTIC IS PEELING OFF DURING USE.
Patient problems: Insufficient Information
MAUDE report 17951697 ↗MalfunctionOct 4, 2023Material Fragmentation; Material Fragmentation
THE CUSTOMER ALLEGED THAT THE GUARDED ELECTRODE TIP INSULATION STARTED TO PEEL AWAY / FRAGMENT DURING USE WITH A POTENTIAL FOR IT TO BREAK OFF INSIDE THE PATIENT. TO THIS DATE, THERE HAS BEEN NO REPORT OF PATIENT OR USER INVOLVEMENT.
Patient problems: Insufficient Information
MAUDE report 17870322 ↗MalfunctionMar 23, 2023Output Problem; Output Problem
THE CUSTOMER ALLEGED THAT AFTER APPROXIMATELY 1 MINUTE OF USE, THE PATIENT EXPERIENCED A SUPERFICIAL BURN TO THE RIGHT CORNER OF THE LIP WHILE USING THE CAUTERY. THE FACILITY APPLIED BACITRACIN TO THE AFFECTED AREA AND REMOVED THE CAUTERY FROM THE FIELD. THERE WAS NO FURTHER HARM TO THE PATIENT.
Patient problems: Superficial (First Degree) Burn
MAUDE report 16600901 ↗MalfunctionDec 10, 2020Excessive Heating
THE DOCTOR WAS USING THE BLADE ELECTRODE ON THE PATIENT WHEN THE BLADE PART BURNED THROUGH THE RUBBER AND BURNED THE PATIENT'S MOUTH.
Patient problems: Burn, Thermal
MAUDE report 10985116 ↗
Other Electrocautery, Gynecologic (And Accessories) devices
- Enseal NSLX137CEthicon Endo-Surgery, LLC · ELECTROCAUTERY, GYNECOLOGIC (AND ACCESSORIES)3 deaths344 reports
- ENSEAL X1 NSLX120LEthicon Endo-Surgery, LLC · ELECTROCAUTERY, GYNECOLOGIC (AND ACCESSORIES)2 deaths172 reports
- Fischer Cone Biopsy Excisor 900-157Coopersurgical, Inc. · Electrocautery, Gynecologic (And Accessories)1 recall0 reports
- LEEP PRECISION™ Generator LP-20-120Coopersurgical, Inc. · Electrocautery, Gynecologic (And Accessories)45 reports
- Harmonic NSLX137SEthicon Endo-Surgery, LLC · ELECTROCAUTERY, GYNECOLOGIC (AND ACCESSORIES)1 death19 reports
- LEEP PRECISION™ Integrated System LP-10-120Coopersurgical, Inc. · Electrocautery, Gynecologic (And Accessories)12 reports
- Fischer Cone Biopsy Excisor 900-151Coopersurgical, Inc. · Electrocautery, Gynecologic (And Accessories)10 reports
- AESCULAP PM438RAesculap AG · ELECTROCAUTERY, GYNECOLOGIC (AND ACCESSORIES)7 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
- 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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