PlumePen PLPRO4520Recalls & reported problems
Conmed Corporation · PlumePen Pro Surgical Smoke Evacuation Pencil, 7/8" (22 mm), 15 ft. (4.6 m) · 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 20845854061203), received between Jul 8, 2022 and Jul 8, 2022 — classified as 1 malfunction.
The most frequently reported specific device problem is “Difficult or Delayed Activation” (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
- Difficult or Delayed Activation1
- 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 8, 2022Overheating of Device; Difficult or Delayed Activation; Overheating of Device; Difficult or Delayed Activation
THE SALES REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER THAT THE DEVICE, PLPRO4520, 20/CA PLUMEPEN PRO NONSTICK(S) WAS BEING USED DURING A LAPAROSCOPIC SIGMOID RESECTION PROCEDURE ON (B)(6) 2022 WHEN IT WAS REPORTED ¿COAG BUTTON DELAYED WHEN ACTIVATED/ OVERHEATED AND BURNT HOLE IN DRAPE.¿ AFTER FURTHER ASSESSMENT IT WAS FOUND THAT THE PATIENT DID NOT OBTAIN A BURN. IT WAS ALSO REPORTED THAT THERE WAS A FIVE-MINUTE DELAY IN THE PROCEDURE. THE PROCEDURE WAS COMPLETED WITH THE USE OF AN UNKNOWN ALTERNATE DEVICE AND THERE WAS NO REPORT OF INJURY, MEDICAL INTERVENTION OR HOSPITALIZATION TO PATIENT OR USER. THIS REPORT IS BEING RAISED ON THE BASIS OF MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14957506 ↗
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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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