PLUMEPEN PLP1020 (UDI 20845854061265)Recalls & reported problems
Conmed Corporation · Class 2
All models of PlumePen (8)
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 20845854061265), received between Jul 11, 2023 and Jul 11, 2023 — classified as 1 malfunction.
The most frequently reported specific device problem is “Overheating of Device” (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.
Most reported problems
Device problems
- Overheating of Device1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 11, 2023Overheating of Device; Overheating of Device
THE SALES REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER THAT THE PLP1020, 20/CA PLUMEPEN ELITE (S), WAS BEING USED DURING A SPINE CASE PROCEDURE ON (B)(6) 2023 WHEN IT WAS REPORTED, ¿ONCE DR. (B)(6) WAS DONE WITH BOVIE, HE PLACED IT ON THE DRAPE AFTER USE. THE BOVIE TIP BURNED THE DRAPE. TEAM CHANGED THE TIP AFTER THIS HAPPENED.¿. THERE WAS NO REPORT OF INJURY, MEDICAL INTERVENTION, OR HOSPITALIZATION FOR THE USER OR PATIENT. THE PROCEDURE WAS COMPLETED WITH AN ALTERNATE DEVICE WITH NO REPORT OF ANY DELAY TIME. THIS REPORT IS BEING RAISED DUE TO THE REPORTED MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17299587 ↗
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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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