PlumePen PLP1020 (UDI 10845854061268)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10845854061268), received between Aug 2, 2023 and Jun 4, 2026 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Mechanical Jam” (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

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 4, 2026Unintended Electrical Shock

  THE SALES REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER THAT THE PLP1020 ELITE SURGICAL SMOKE EVACUATION PENCIL DEVICE WAS BEING USED ON (B)(6) 2026 DURING A CIRCUMCISION PROCEDURE WHEN IT WAS REPORTED ¿DR. HAD BEEN USING A BOVIE FOR APPROXIMATELY FOR 1 HOUR AND THEN SHE FELT A ZAP AND QUICKLY PUT DOWN THE BOVIE. HER HAND FINGER WAS HURTING AND WHEN SHE REMOVED HER GLOVE, SHE NOTICED SMALL BURN MARK AND A REDDENED AREA.¿. FURTHER ASSESSMENT FOUND THAT SURGEON WAS NOT DIAGNOSED WITH BURN SEVERITY (NO PATIENT IMPACT ONLY SURGEON). BURN LOCATED ON RIGHT INDEX FINGER. NOT TREATMENT REPORTED - MENTIONED REDNESS AND SORE. PATIENT STATUS - UNAFFECTED (SURGEON EXPERIENCED BURN). THERE WAS NO REPORT OF MEDICAL INTERVENTION, OR EXTENDED HOSPITALIZATION FOR THE PATIENT OR USER. THIS REPORT IS BEING RAISED DUE TO THE REPORTED MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

  Patient problems: Burn(s)

  MAUDE report 25392236 ↗
• MalfunctionSep 5, 2024Mechanical Jam; Mechanical Jam

  A SALES REPRESENTATIVE REPORTED ON BEHALF OF A CUSTOMER THAT THE PLP1020, 20/CA PLUMEPEN ELITE (S) DEVICE WAS BEING USED ON (B)(6) 2024, AND ¿BUTTON IS STUCK IN "ON" POSITION, WON'T TURN OFF.¿. FOLLOW-UP ASSESSMENT WAS ATTEMPTED BUT UPON RESPONSE, THE CUSTOMER PROVIDED NO FURTHER INFORMATION; THEREFORE, IT COULD NOT BE DETERMINED IF THIS WAS AN EVENT OF SELF-ACTIVATION AND WHETHER IT OCCURRED INTRA-OPERATIVELY OR DURING PRE-OPERATIVE TESTING. THERE WAS NO REPORT OF INJURY, MEDICAL/SURGICAL INTERVENTION, OR HOSPITALIZATION FOR THE 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 20147670 ↗
• MalfunctionAug 2, 2023Self-Activation or Keying; Self-Activation or Keying

  THE SALES REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER THAT THE PLP1020, 20/CA PLUMEPEN ELITE (S), WAS BEING USED DURING AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE WHEN IT WAS REPORTED, ¿THE PLUME PEN ELITE HAND PIECES MUST HAVE AN ISSUE WITH THE CUT BUTTON AS THE STAFF SAY THAT THEY ARE ACTIVATING THE DIATHERMY AS SOON AS THEY ARE CONNECTED.¿. THERE WAS NO INITIAL REPORT OF INJURY, MEDICAL INTERVENTION, OR HOSPITALIZATION FOR THE PATIENT OR USER. THE PROCEDURE WAS COMPLETED AS PLANNED. FURTHER QUESTIONING WAS SENT TO THE REPORTER TO CLARIFY IF SELF-ACTIVATION IS BEING REPORTED; HOWEVER, WE HAVE NOT RECEIVED AN ANSWER TO DATE. 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 17441350 ↗