PlumePen PLPUL2520Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 20845854061227), received between Oct 26, 2022 and Sep 15, 2025 — classified as 1 injury, 3 malfunctions.

The most frequently reported specific device problem is “Material Fragmentation” (4 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

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 15, 2025Material Fragmentation; Material Fragmentation

  THE CUSTOMER REPORTED THAT THE DEVICE, PLPUL2520, ULTRA SURGICAL SMOKE EVACUATION PENCIL WAS BEING USED ON (B)(6) 2025 AND THE "CAUTERY PENCIL WAS BEING USED INSIDE OPEN CHEST. CAUTERY STOPPED WORKING FOR A MOMENT AND WHEN EXAMINED A SMALL PIECE OF PLASTIC WHERE CAUTERY TIP SITS BROKE OFF AND FELL INTO OPEN CAVITY. SMALL PIECE WAS FOUND.¿ THERE WAS NO IMPACT OR INJURY TO THE PATIENT OR USER. 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 23050377 ↗
• MalfunctionJul 25, 2025Material Fragmentation; Material Fragmentation

  A CUSTOMER REPORTED THAT THE PLPUL2520, ULTRA SURGICAL SMOKE EVACUATION PENCIL DEVICE WAS USED IN AN OGD & TOTAL GASTRECTOMY PROCEDURE ON (B)(6) 2025, AND ¿THE PLASTIC PART OF THE DIATHERMY TIP EXTENSION WAS BROKEN WHILST USING FOR SURGERY¿. FURTHER ASSESSMENT FOUND THAT, "ON THE PLUME-PEN, THERE IS A PLASTIC ATTACHMENT CONTINUING FROM THE DIATHERMY TIP TO THE PEN, THIS PLASTIC CONNECTION WAS DISPLACED/ BROKEN/ SEPARATED/ NOT IN CONTINUITY. WHEN NOTICED, THE BROKEN PIECE WAS STILL INSIDE THE PEN. THE SITE WAS THOROUGH INSPECTED AND NOTHING FOUND. MALFUNCTIONED INSTRUMENT HAD NO EFFECT ON PATIENT¿S SURGICAL OUTCOME". THE PROCEDURE WAS COMPLETED AS NORMAL WITH AN ALTERNATE SAME DEVICE AND A DELAY OF TWO MINUTES. THERE WAS NO REPORT OF INJURY, MEDICAL/SURGICAL INTERVENTION, OR EXTENDED HOSPITALIZATION FOR THE PATIENT. 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 22608454 ↗
• InjuryJun 11, 2025Material Fragmentation; Material Fragmentation

  THE SALES REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER THAT THE DEVICE, PLPUL2520, ULTRA SURGICAL SMOKE EVACUATION PENCIL, WAS BEING USED DURING AN OPEN-HEART PROCEDURE ON (B)(6) 2025 WHEN IT WAS REPORTED, ¿BLADE AND HOUSING BROKE OFF AND INTO THE SMOKE CAPTURE PORT.¿. AN ALTERNATE SAME DEVICE WAS USED TO COMPLETE THE PROCEDURE CAUSING A DELAY OF 5-MINUTES. THERE WAS NO REPORT OF INJURY, MEDICAL INTERVENTION, OR HOSPITALIZATION FOR THE PATIENT. THERE WAS NO REPORT OF DEVICE BEING IN CONTACT WITH THE PATIENT AT THE TIME OF THE MALFUNCTION. A GOOD FAITH EFFORT WAS CONDUCTED BY CONMED TO ASSURE NO FRAGMENTATION CAME INTO CONTACT WITH THE PATIENT; HOWEVER, TO DATE WE HAVE NOT RECEIVED A RESPONSE. THIS REPORT IS BEING RAISED DUE TO THE REPORTED INJURY OF UNKNOWN FRAGMENTATION CONTACT TO THE PATIENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 22182858 ↗
• MalfunctionOct 26, 2022Material Fragmentation; Material Fragmentation

  THIS COMPLAINT WAS CREATED DUE TO THE RECEIPT OF A MEDWATCH REPORT (MW5112276) ON 12OCT22. THE CURRENT COMPLAINT DATABASE HAS BEEN RESEARCHED FOR THIS EVENT AND THERE WERE NO FINDINGS. THE REPORT WAS FOUND TO BE WRITTEN AGAINST PLPUL2520, PLUMEPEN ULTRA SURGICAL SMOKE EVACUATION PENCIL. IT WAS STATED THAT THE DEVICE WAS BEING USED DURING AN UNKNOWN PROCEDURE THAT OCCURRED ON (B)(6) 2022. THE REPORT STATED, ¿WHILE USING THE PLUMEPEN SMOKE EVACUATION PENCIL BOVIE, DURING SURGICAL PROCEDURE, THE BLADE FELL OUT WHILE IN USE AT THE SURGICAL SITE. ALSO NOTED THAT A PLASTIC PIECE FROM INSIDE THE PLASTIC SHEATH ON THE DISTAL END OF THE BOVIE FELL INTO THE PATIENT. THE PIECE WAS RETRIEVED. THE PATIENT WAS NOT INJURED AS A RESULT OF THIS EVENT.¿. THE COMPONENT WAS RETRIEVED FROM THE PATIENT. THERE WAS NO REPORT OF INJURY, MEDICAL INTERVENTION, OR HOSPITALIZATION FOR THE PATIENT. 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 15674267 ↗