MalfunctionHQP
CAUTERY HIGH TEMP FINE TIP
Received Jul 14, 2026 · Event occurred Jun 9, 2026
Report 3002750084-2026-00073 · MDR key 25813465
Device
Generic name
Disposable Cautery
Manufacturer
Aspen Surgical Products, Inc.Model number
AA01Lot number
0425X
Product problems
- Fire
Patient
NA · Unknown
- Partial thickness (Second Degree) Burn
Narrative
Description of Event or Problem
COMPLAINANT ALLEGES "ON (B)(6) 2026, DURING A BLEPHAROPLASTY PROCEDURE, WE USED A CAUTERY HIGH TEMP FINE TIP (REF: AA01, LOT: 0425X) FOR PREPARATION OF THE SKIN AND UNDERLYING MUSCLE. DURING THE VERY FIRST USE OF THE CAUTERY, A FLAME DEVELOPED, WHICH WE WERE ABLE TO EXTINGUISH IMMEDIATELY."
Additional Manufacturer Narrative
THE DEVICE HAS BEEN RETURNED AND IS AWAITING EVALUATION. THE INVESTIGATION IS ONGOING. ONCE WE HAVE ADDITIONAL RELEVANT INFORMATION IT WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.