PlumePen EliteRecalls & reported problems
Buffalo Filter · Smoke Plume Electrosurgical Pencil, Non-stick blade · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00815198012090), received between Feb 1, 2019 and Feb 1, 2019 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Device Contaminated During Manufacture or Shipping” (2 reports).
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
- Device Contaminated During Manufacture or Shipping2
Patient problems
- No Known Impact Or Consequence To Patient1
- No Patient Involvement1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 1, 2019Device Contaminated During Manufacture or Shipping
A SHORT BLACK HAIR FOUND IN CAUTERY HOLSTER ON BUFFALO CAUTERY PENCIL. OPERATION ROOM SET UP AND BACK TABLE DISASSEMBLED AND NEW PACK OPENED. THIS WAS DISCOVERED BEFORE IMPACTING PATIENT. NEW DEVICE RETRIEVED AND OPENED.
Patient problems: No Patient Involvement
MAUDE report 8296621 ↗MalfunctionFeb 1, 2019Device Contaminated During Manufacture or Shipping
RED HAIR FOUND IN THE STERILE CAUTERY HOLSTER ON BUFFALO CAUTERY PENCIL. OPERATION ROOM SET UP HAD TO BE DISASSEMBLED AND A NEW PACK OPENED. THIS WAS NOTED BY STAFF AND WAS TAKEN DOWN PRIOR TO REACHING THE PATIENT. NEW DEVICE HAD TO BE OPENED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8296613 ↗
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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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