PlumePenRecalls & reported problems across all models

We found 8 models of PlumePen by Conmed Corporation in the FDA's device registry (GUDID). Together they are named in 132 adverse event reports in the FDA's MAUDE database, received between Mar 21, 2022 and Sep 10, 2026 — classified as 21 injuries, 111 malfunctions.

The most frequently reported specific device problem is “Material Fragmentation” (41 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported PlumePen problems

PlumePen models

8 models, most reported first. Each model has its own page with its reports, recalls and device details.

• PlumePen PLPUL2020

  Electrosurgical, cutting & coagulation & accessories
  52 reports
• PlumePen PLP2020

  Electrosurgical, cutting & coagulation & accessories
  50 reports
• PlumePen PLP2520

  Electrosurgical, cutting & coagulation & accessories
  20 reports
• PlumePen PLPUL2520

  Electrosurgical, cutting & coagulation & accessories
  4 reports
• PlumePen PLP1020

  Electrosurgical, cutting & coagulation & accessories
  3 reports
• PlumePen PLPRO4020

  Electrosurgical, cutting & coagulation & accessories
  1 report
• PlumePen PLPRO4520

  Electrosurgical, cutting & coagulation & accessories
  1 report
• PLUMEPEN PLP1020

  Electrosurgical, cutting & coagulation & accessories
  1 report

Recent PlumePen adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionSep 10, 2026Unintended Electrical Shock

  Patient problems: Electric Shock

  MAUDE report 50713267 ↗
• MalfunctionJul 17, 2026Material Fragmentation

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25853155 ↗
• MalfunctionJul 10, 2026Self-Activation or Keying

  THE CUSTOMER REPORTED THAT THE DEVICE PLPUL2020, ULTRA SURGICAL SMOKE EVACUATION PENCIL WAS BEING USED ON (B)(6) 2026 DURING A CLOSURE OF ILEOSTOMY AND ¿CAUTERY PEN USED IN SURGICAL CASE GOES OFF EVEN WHEN SURGEON DOES NOT PRESS BUTTON TO ACTIVATE CAUTERY PEN. POTENTIAL FOR PATIENT HARM.¿ 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 25779467 ↗
• 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 ↗
• MalfunctionJun 4, 2026Material Fragmentation

  THE DISTRIBUTOR REPORTED ON BEHALF OF THEIR CUSTOMER THAT THE PLPUL2020 ULTRA SURGICAL SMOKE EVACUATION PENCIL, DEVICE WAS BEING USED ON (B)(6) 2026 DURING A WHIPPLE SURGERY PROCEDURE WHEN IT WAS REPORTED ¿THE BLADE HOLDER COLLAPSE AND TELESCOPIC CAPTURE PORT CRACKED DURING PROCEDURE.¿. FURTHER ASSESSMENT QUESTIONING FOUND THAT THE DEVICE DID FRAGMENT INTO THE SURGICAL SITE AND WAS RETRIEVED BY A FORCEP. THE PROCEDURE WAS COMPLETED AND THERE WAS NO REPORT OF INJURY, 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: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25391515 ↗
• MalfunctionMay 15, 2026Material Fragmentation

  THE CUSTOMER REPORTED THAT THE PLPUL2020 ULTRA SURGICAL SMOKE EVACUATION PENCIL, DEVICE WAS BEING USED ON (B)(6) 2026 DURING AN UNKNOWN PROCEDURE WHEN IT WAS REPORTED ¿ELECTRODE INSERTION PORT ON PENCIL CRACKED AND ELECTRODE FELL IN WOUND.¿ FURTHER ASSESSMENT QUESTIONING FOUND THAT THE FRAGMENT WAS RETRIEVED FROM THE SURGICAL SITE. THE PROCEDURE WAS COMPLETED WITH THE USE OF THE SAME ALTERNATE DEVICE AND A 5-MINUTE DELAY WAS REPORTED. THERE WAS NO REPORT OF INJURY, MEDICAL INTERVENTION OR EXTENDED STAY FOR THE PATIENT. 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 25182616 ↗
• MalfunctionMay 7, 2026Material Fragmentation

  A SALES REPRESENTATIVE REPORTED ON BEHALF OF A CUSTOMER THAT THE PLPUL2020, ULTRA SURGICAL SMOKE EVACUATION PENCIL DEVICE WAS USED IN AN UNKNOWN PROCEDURE ON (B)(6) 2026, AND ¿THE ACTIVE ELECTRODE CONNECTION BROKE OFF DURING THE PROCEDURE RENDERING THE PRODUCT UNUSABLE, AND ANOTHER DEVICE HAS TO BE OPENED TO COMPLETE THE PROCEDURE. NO PATIENT WAS INJURED IN THE PROCEDURE, AND THE PROCEDURE WAS COMPLETED WITH ONLY A MINOR DELAY WITH OPENING A NEW DEVICE. THE BROKEN OFF PIECE WAS RECOVERED AND REMOVED FROM THE SURGICAL FIELD.¿. FURTHER ASSESSMENT FOUND "THE FRAGMENT FELL ONTO A SUPERFICIAL INCISION OF THE PATIENT AND WAS EASILY RETRIEVED. IT DID NOT FALL INTO A CAVITY OR INSIDE THE PATIENT. THE HOUSING THAT HOLDS THE PENCIL BLADE/TIP AND THE BLADE ITSELF IS WHAT FELL ONTO THE PATIENT.". THERE WAS NO 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 25110517 ↗
• MalfunctionApr 3, 2026Material Fragmentation

  THE SALES REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER THAT THE DEVICE, PLPUL2020, ULTRA SURGICAL SMOKE EVACUATION PENCIL, WAS BEING USED DURING AN UNKNOWN PROCEDURE ON (B)(6) 2026 WHEN IT WAS REPORTED, ¿PLUMEPEN ULTRA CRACKED IN THE MIDDLE OF THE PROCEDURE. THE PRODUCT IS AVAILABLE FOR RETURN. ACCOUNT REPORTED THIS HAPPENING TWO OTHER TIMES REPORTING THAT THE CRACK RESULTED IN PLASTIC PIECES FALLING INTO THE PATIENT.¿. THERE WAS NO REPORT OF INJURY, MEDICAL INTERVENTION, OR HOSPITALIZATION FOR THE PATIENT. THE PROCEDURE WAS COMPLETED AS PLANNED. FURTHER ASSESSMENT FOUND THAT ALL FRAGMENTATION WAS RETRIEVED FROM THE PATIENT. 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 24774836 ↗
• InjuryMar 5, 2026Sparking

  THE SALES REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER THAT THE PLP2020 ELITE SURGICAL SMOKE EVACUATION PENCIL DEVICE WAS BEING USED DURING AN IMPLANT EXCHANGE PROCEDURE ON (B)(6) 2026 WHEN IT WAS REPORTED ¿SURGEON WAS OPERATING WITH OUR PLP2020 PENCIL WITH THE EXTENDED ACCESSORY ELECTRODE. THE BASE OF THE ELECTRODE THAT CONNECTS TO THE SHAFT ACTUALLY SPARKED AND BURNED AT THAT SITE AND CAUSED A PATIENT BURN.¿ FURTHER ASSESSMENT QUESTIONING FOUND THAT THE PATIENT OBTAINED A 3RD DEGREE BURN ON THE LEFT INFERIOR BREAST. THE BURN WAS EXCISED DUE TO ITS PROXIMAL LOCATION TO THE WOUND EDGE. THE CURRENT STATUS OF THE PATIENT IS NOT YET SEEN IN FOLLOW UP. THE PROCEDURE WAS COMPLETE WITH A ¿SHORT BOVIE TIP¿. THERE WAS NO REPORT OF EXTENDED HOSPITALIZATION FOR THE PATIENT OR USER. THE 139025EXT ACCESSORY ELECTRODE COATED NEEDLE WITH EXTENDED INSULATION WAS ALSO USED IN THIS PROCEDURE AND WILL BE LISTED AS A CONCOMITANT DEVICE AND THERE ARE NO ALLEGATIONS AGAINST IT. THIS REPORT IS BEING RAISED ON THE REPORTED INJURY DUE PATIENT OBTAINING A 3RD DEGREE BURN.

  Patient problems: Full thickness (Third Degree) Burn

  MAUDE report 24517708 ↗
• MalfunctionMar 4, 2026Material Fragmentation

  THE SALES REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER THAT THE PLPUL2020 ULTRA SURGICAL SMOKE EVACUATION PENCIL DEVICE WAS BEING USED DURING A LAPAROTOMY PROCEDURE ON (B)(6) 2026 WHEN IT WAS REPORTED ¿A PIECE OF PLASTIC BROKE OFF THE INSIDE OF THE DIATHERMY TIP WHEN CHANGING THE TIP. THE CLEAR PLASTIC WAS FOUND ON THE DRAPES NEAR THE SURGICAL INCISION SITE.¿. THE PROCEDURE WAS COMPLETED WITH THE USE OF AN ALTERNATE COVIDIEN DEVICE AND A 2-MINUTE DELAY. THERE WAS NO REPORT OF INJURY, 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: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24505213 ↗
• MalfunctionFeb 6, 2026Material Fragmentation

  A CUSTOMER REPORTED THAT THE PLPUL2020, ULTRA SURGICAL SMOKE EVACUATION PENCIL DEVICE WAS USED IN AN ABDOMINOPLASTY-FLEUR DE LIS PROCEDURE ON (B)(6) 2026, AND ¿THE PLUME PENS ARE STILL BREAKING. THE ONE THEY ARE USING IN THE CURRENT CASE DID THE SAME THING SHE DESCRIBED TO YOU WHEN THE PORTION OF THE PEN INSIDE THAT HOLDS THE TIP INTACT FAILS CAUSING THE TIP TO BE LOOSE AND WIGGLE AROUND INSIDE THE SHEATH¿ IT'S NOT THE SMOKE CAPTURE PORT (SHEATH), IT'S THE PORTION INSIDE OF THAT HOLDS THE TIP THAT BREAKS AND DOESN'T 'HOLD' THE TIP WELL, OR BECOMES LOOSE ALTOGETHER.... IT'S LIKE A PORTION OF WHATEVER HOLDS THE TIP IN BREAKS AND THEN IT CAN'T HOLD THE TIP WELL OR AT ALL. THEY WERE DOING AN ABDOMINOPLASTY-FLEUR DE LIS. SHE SAID IT DID FALL OUT ONTO THE PATIENT." FURTHER ASSESSMENT FOUND "IT WAS ONLY THE TIP THAT FELL OUT ONTO THE PATIENT, NOT THE METAL COMPONENT THAT HOLD THE TIP." THE TIP FELL ONTO - NOT INTO - THE PATIENT, AND WAS REMOVED FROM THE FIELD. 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 24278276 ↗
• MalfunctionJan 28, 2026Material Fragmentation

  A CUSTOMER REPORTED THAT THE PLPUL2020, ULTRA SURGICAL SMOKE EVACUATION PENCIL DEVICE WAS USED IN AN UNKNOWN PROCEDURE ON (B)(6) 2025, AND ¿THE PART THAT HOLDS THE ELECTRODE BECOMES WEAK AND BREAKS. SO FAR, THIS HAS HAPPENED TWICE, AND ALL PIECES WERE RECOVERED, BUT IT IS VERY DANGEROUS IF ANY REMAIN INSIDE THE PATIENT (TRANSPARENT PLASTIC MATERIAL).¿. THERE WAS NO REPORT OF INJURY, MEDICAL/SURGICAL INTERVENTION, OR EXTENDED HOSPITALIZATION FOR THE PATIENT. ATTEMPTS WERE MADE TO OBTAIN FURTHER INFORMATION FROM THE CUSTOMER, BUT NO RESPONSE HAS BEEN RECEIVED TO DATE. 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 24198430 ↗
• MalfunctionJan 28, 2026Material Fragmentation

  A CUSTOMER REPORTED THAT THE PLPUL2020, ULTRA SURGICAL SMOKE EVACUATION PENCIL DEVICE WAS USED IN AN UNKNOWN PROCEDURE ON AN UKNOWN DATE, AND ¿THE PART THAT HOLDS THE ELECTRODE BECOMES WEAK AND BREAKS. SO FAR, THIS HAS HAPPENED TWICE, AND ALL PIECES WERE RECOVERED, BUT IT IS VERY DANGEROUS IF ANY REMAIN INSIDE THE PATIENT (TRANSPARENT PLASTIC MATERIAL).¿. THERE WAS NO REPORT OF INJURY, MEDICAL/SURGICAL INTERVENTION, OR EXTENDED HOSPITALIZATION FOR THE PATIENT. ATTEMPTS WERE MADE TO OBTAIN FURTHER INFORMATION FROM THE CUSTOMER, BUT NO RESPONSE HAS BEEN RECEIVED TO DATE. 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 24198429 ↗
• MalfunctionJan 14, 2026Material Fragmentation

  A SALES REPRESENTATIVE REPORTED ON BEHALF OF A CUSTOMER THAT THE PLPUL2020, ULTRA SURGICAL SMOKE EVACUATION PENCIL DEVICE WAS USED IN AN UNKNOWN PROCEDURE ON (B)(6) 2025, AND ¿A PLASTIC PART OF THE CANNULA BROKE DURING THE PROCEDURE. ALL PARTS WERE RETRIEVED BY SURGEONS AND NURSES. THE PROCEDURE AND HOW THE CANNULA BROKE ARE UNKNOWN, UNAVAILABLE.¿ THE PROCEDURE WAS COMPLETED WITH THE USE OF AN ALTERNATE DEVICE AND A DELAY OF 2 MINUTES. FURTHER ASSESSMENT FOUND THE DEVICE HAD FRAGMENTED AND FALLEN INTO THE PATIENT AND WAS EASILY FOUND AND RETRIEVED. 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 24066387 ↗
• MalfunctionJan 13, 2026Material Fragmentation

  THE CUSTOMER REPORTED THAT THE THAT THE PLPUL2020 ULTRA SURGICAL SMOKE EVACUATION PENCIL, DEVICE WAS BEING USED ON 02DEC25 DURING A WHIPPLE PROCEDURE WHEN IT WAS REPORTED ¿THE BLADE HOLDER COLLAPSE AND TELESCOPIC CAPTURE PORT MELTED DURING PROCEDURE.¿. FURTHER ASSESSMENT QUESTIONING FOUND THE DEVICE DID FRAGMENT INTO THE SURGICAL SITE AND WAS REMOVED WITH THE USE OF FORCEPS. THE PROCEDURE WAS COMPLETED WITH THE USE OF THE SAME ALTERNATE DEVICE AND A 15-MINUTE DELAY. THERE WAS NO REPORT OF INJURY, 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: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24055485 ↗

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