PlumePen PLPUL2020Recalls & reported problems

Summary

The FDA's MAUDE database contains 52 adverse event reports that list this exact device (DI 20845854061210), received between Sep 9, 2022 and Jul 17, 2026 — classified as 6 injuries, 46 malfunctions.

The most frequently reported specific device problem is “Material Fragmentation” (31 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 52 reports, in the reporter's own words as published by the FDA.

• 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, 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 ↗
• 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 ↗
• MalfunctionJan 8, 2026Material Fragmentation

  THE SALES REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER THAT THE PLPUL2020 ULTRA SURGICAL SMOKE EVACUATION PENCIL DEVICE WAS FOUND DURING A NON-SURGICAL EVENT ON 16DEC25 WHEN IT WAS REPORTED ¿PIN LOOSE IN PACKAGE.¿. FURTHER ASSESSMENT QUESTIONING FOUND THAT THE DEVICE¿S ELECTRODE WAS LOOSE IN THE PACKAGE. 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 24002325 ↗
• MalfunctionDec 19, 2025Material Fragmentation; Material Fragmentation

  THE CUSTOMER REPORTED THAT THE DEVICE, PLPUL2020, ULTRA SURGICAL SMOKE EVACUATION PENCIL, WAS BEING USED DURING A GYN PROCEDURE ON (B)(6) 2025 WHEN IT WAS REPORTED, ¿DURING A CASE WITH DR. VIAU IN GYNECOLOGY, THE PLUMEPEN ULTRA BROKE WHEN HE TRIED TO UNCLIP IT TO LENGTHEN IT. A PIECE FELL INTO THE PATIENT, AND WAS LATER FOUND.". THERE WAS NO REPORT OF INJURY, MEDICAL INTERVENTION, OR HOSPITALIZATION FOR THE PATIENT. THE PROCEDURE WAS REPORTED TO HAVE BEEN COMPLETED USING AN ALTERNATE DEVICE WHICH CAUSED A 5-MINUTE DELAY. 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 23848202 ↗
• MalfunctionDec 16, 2025Material Fragmentation; Material Fragmentation

  THE SALES REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER THAT THE PLPUL2020 ULTRA SURGICAL SMOKE EVACUATION PENCIL DEVICE WAS BEING USED DURING A BREAST AUGMENTATION PROCEDURE ON (B)(6) 2025 WHEN IT WAS REPORTED ¿PLPUL2020 PLASTIC ELECTRODE HOLDER SNAPPED DURING USE.¿ FURTHER ASSESSMENT QUESTIONING FOUND THAT ¿NO FRAGMENTS WERE REPORTED TO HAVE FALLEN INTO SURGICAL SITE. THE ISSUE OCCURRED WHEN CLEANING THE TIP OF AN ELECTRODE, THIS ELECTRODE WAS NOT THE ELECTRODE THAT THE PLPUL2020 HAS FITTED WHEN PACKAGED. THE TIP WAS CHANGED DURING THE PROCEDURE. THE PLASTIC HOUSING THAT SECURES THE TIP WAS REPORTED TO HAVE BEEN "BROKEN.¿ THE PROCEDURE WAS COMPLETED WITHOUT THE USE OF AN ALTERNATE DEVICE AND THERE WAS A 5-MINUTE DELAY REPORTED. 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 23815323 ↗
• InjuryDec 12, 2025Material Fragmentation; Material Fragmentation

  THE SALES REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER THAT THE DEVICE, PLPUL2020, ULTRA SURGICAL SMOKE EVACUATION PENCIL, WAS BEING USED DURING AN OPEN LIVER PROCEDURE ON (B)(6) 2025 WHEN IT WAS REPORTED, ¿THE INNER PLASTIC OF THE PENCIL (WHERE THE DIATHERMY TIP ATTACHES TO THE HANDPIECE) SNAPPED WHILE ATTACHING THE TIP.¿. FURTHER ASSESSMENT WAS REQUESTED FROM THE REPORTER. THE STATEMENT RECEIVED READ, ¿I KNOW FOR CERTAIN THE GUARDED ELECTRODE TIP FELL INTO THE ABDOMEN AND WAS RETRIEVED PROMPTLY BY HAND. I CANNOT SAY FOR CERTAIN IF ANY OTHER PIECE OF PLASTIC FROM THE PLUME PEN FELL INTO THE CAVITY OR NOT. IF IT DID, THIS WAS NOT RETRIEVED.¿ THERE WAS NO REPORT OF MEDICAL INTERVENTION OR HOSPITALIZATION FOR THE PATIENT. THE PROCEDURE WAS REPORTED AS HAVING BEEN COMPLETED AS PLANNED. THIS REPORT IS BEING RAISED DUE TO THE REPORTED INJURY OF POSSIBLE FOREIGN BODY LEFT IN PATIENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 23788098 ↗
• MalfunctionNov 18, 2025Material Fragmentation; Material Fragmentation

  THE SALES REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER THAT THE PLPUL2020, ULTRA SURGICAL SMOKE EVACUATION PENCIL WAS BEING USED ON (B)(6) 2025 AND ¿¿USING THE ULTRA AND THE PIECE INSIDE THE ULTRA BROKE OFF WHEN SWAPPING OUT THE ELECTRODE¿" THERE WAS NO REPORT OF IMPACT OR INJURY TO 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 23580551 ↗
• MalfunctionNov 18, 2025Material Fragmentation; Material Fragmentation

  THE SALES REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER THAT THE PLPUL2020, ULTRA SURGICAL SMOKE EVACUATION PENCIL WAS BEING USED ON (B)(6) 2025 AND ¿¿USING THE ULTRA AND THE PIECE INSIDE THE ULTRA BROKE OFF WHEN SWAPPING OUT THE ELECTRODE¿" THERE WAS NO REPORT OF IMPACT OR INJURY TO 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 23580546 ↗
• InjuryJun 11, 2025Material Fragmentation; Material 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) 2025 WHEN IT WAS REPORTED, ¿THE INNER PIECE CRACKED AND PIECES BROKE OFF AND HAD TO BE LOCATED INSIDE THE PATIENT.¿. AN ALTERNATE SAME DEVICE WAS USED TO COMPLETE THE PROCEDURE CAUSING A DELAY OF UNKNOWN MINUTES. THERE WAS NO REPORT OF INJURY, MEDICAL INTERVENTION, OR HOSPITALIZATION FOR THE PATIENT. THE PATIENT¿S STATUS WAS REPORTED AS ¿GOOD¿. A GOOD FAITH EFFORT WAS CONDUCTED BY CONMED TO DETERMINE IF ALL FRAGMENTATION HAD BEEN RETRIEVED; HOWEVER, TO DATE WE HAVE NOT RECEIVED A RESPONSE. THIS REPORT IS BEING RAISED DUE TO THE REPORTED INJURY OF POSSIBLE FOREIGN BODY LEFT IN PATIENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 22182856 ↗
• MalfunctionMay 6, 2025Material Fragmentation; Material Fragmentation

  THE CUSTOMER REPORTED THAT THE PLPUL2020, ULTRA SURGICAL SMOKE EVACUATION PENCIL, DEVICE WAS BEING USED ON (B)(6) 2025 DURING A BBR PROCEDURE WHEN IT WAS REPORTED ¿TOWARDS THE END OF A LONG CASE, THE PLASTIC COMPONENT THAT HOLDS THE ELECTRODE HAS CRACKED AND BROKEN, WITH SHARDS OF PLASTIC FOUND WITHIN THE WOUND. THE ELECTRODE IS PLACED IN THE HOLDER AT THE BEGINNING OF THE CASE AND IS NOT CHANGED OR REMOVED.¿. FURTHER ASSESSMENT FOUND THAT THE FRAGMENT WAS REMOVED FROM THE WOUND. THE PROCEDURE WAS COMPLETED WITH THE USE OF THE SAME ALTERNATE DEVICE AND A 10-MINUTE DELAY. THERE WAS NO REPORT OF INJURY, MEDICAL INTERVENTION, OR EXTENDED HOSPITALIZATION FOR THE PATIENT OR USER. THIS REPORT IS BEING RAISED ON THE REPORTED MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21969250 ↗
• MalfunctionMay 6, 2025Material Fragmentation; Material Fragmentation

  THE CUSTOMER REPORTED THAT THE PLPUL2020, ULTRA SURGICAL SMOKE EVACUATION PENCIL, DEVICE WAS BEING USED ON (B)(6) 2025 DURING AN ABDOMINOPLASTY & MASTOPEXY PROCEDURE WHEN IT WAS REPORTED ¿TOWARDS THE END OF A LONG CASE, THE PLASTIC COMPONENT THAT HOLDS THE ELECTRODE HAS CRACKED AND BROKEN, WITH SHARDS OF PLASTIC FOUND WITHIN THE WOUND. THE ELECTRODE IS PLACED IN THE HOLDER AT THE BEGINNING OF THE CASE AND IS NOT CHANGED OR REMOVED.¿ FURTHER ASSESSMENT FOUND THAT THE FRAGMENT WAS REMOVED FROM THE WOUND. THE PROCEDURE WAS COMPLETED WITH THE USE OF THE SAME ALTERNATE DEVICE AND A 10-MINUTE DELAY. THERE WAS NO REPORT OF INJURY, MEDICAL INTERVENTION, OR EXTENDED HOSPITALIZATION FOR THE PATIENT OR USER. THIS REPORT IS BEING RAISED ON THE REPORTED MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21969248 ↗
• MalfunctionApr 24, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A SALES REPRESENTATIVE REPORTED ON BEHALF OF A CUSTOMER THAT THE PLPUL2020, ULTRA SURGICAL SMOKE EVACUATION PENCIL DEVICE WAS USED IN PEDIATRIC AND ADULT HERNIA PROCEDURES ON (B)(6) 2025, AND "ON TWO SEPARATE DAYS, WITH TWO DIFFERENT GENERAL SURGERY SURGEONS, THEY BURNED THEMSELVES USING THE CAUTERY. THE SURGEONS CHECKED FOR ANY HOLES IN THE GLOVES". FURTHER ASSESSMENT FOUND THE ELECTRODE CAUSED A "LIGHT BURN...ON THE FINGERS", AND "THE SURGEONS CONFIRMED THERE WERE NO HOLES IN THE GLOVES". THE PROCEDURE WAS COMPLETED "WITHOUT PROBLEM" AND WITH NO DELAY, USING "ANOTHER OF THE SAME CAUTERY". THERE WAS NO MEDICAL OR SURGICAL INTERVENTION REQUIRED FOR THE BURN, AND NO IMPACT TO THE PATIENT OR OTHERS. THERE WAS NO ALLEGATION OF A DEVICE MALFUNCTION. THIS REPORT IS BEING RAISED ON THE BASIS OF MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

  Patient problems: Superficial (First Degree) Burn

  MAUDE report 21899110 ↗
• MalfunctionApr 24, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A SALES REPRESENTATIVE REPORTED ON BEHALF OF A CUSTOMER THAT THE PLPUL2020, ULTRA SURGICAL SMOKE EVACUATION PENCIL DEVICE WAS USED IN PEDIATRIC AND ADULT HERNIA PROCEDURES ON APPROXIMATELY ON (B)(6) 2025, AND "ON TWO SEPARATE DAYS, WITH TWO DIFFERENT GENERAL SURGERY SURGEONS, THEY BURNED THEMSELVES USING THE CAUTERY. THE SURGEONS CHECKED FOR ANY HOLES IN THE GLOVES¿. FURTHER ASSESSMENT FOUND THE ELECTRODE CAUSED A "LIGHT BURN...ON THE FINGERS", AND "THE SURGEONS CONFIRMED THERE WERE NO HOLES IN THE GLOVES". THE PROCEDURE WAS COMPLETED "WITHOUT PROBLEM" AND WITH NO DELAY, USING "ANOTHER OF THE SAME CAUTERY". THERE WAS NO MEDICAL OR SURGICAL INTERVENTION REQUIRED FOR THE BURN, AND NO IMPACT TO THE PATIENT OR OTHERS. THERE WAS NO ALLEGATION OF A DEVICE MALFUNCTION. THIS REPORT IS BEING RAISED ON THE BASIS OF MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

  Patient problems: Superficial (First Degree) Burn

  MAUDE report 21899054 ↗
• InjuryApr 1, 2025Self-Activation or Keying; Self-Activation or Keying

  THE SALES REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER THAT THE PLPUL2020, ULTRA SURGICAL SMOKE EVACUATION PENCIL WAS BEING USED ON (B)(6) 2025 AND THERE WAS ¿SIGNIFICANT INTERFERENCE GENERATED BY THE ELECTROCAUTERY, PREVENTING THE EMG (EVOKED POTENTIAL) DEVICE FROM FUNCTIONING PROPERLY. CONSEQUENCE: LOSS OF CONFIDENCE IN THE EMG DEVICE, PATIENT HAD TO BE AWAKENED QUICKLY TO CHECK FOR ANY IMPAIRMENTS. RESULT: SLIGHT IMPAIRMENTS, WHICH MAY BE TEMPORARY OR PERMANENT. OCCURRED AT THE END OF A SCOLIOSIS CASE, DURING CLOSURE. GENERATOR USED FT10. GENERATOR FT10 WAS ACTIVATED FOR 5 MINUTES WITHOUT NOTICING WHICH INTERFERED WITH ECG READING, ACCOUNT IS WONDERING IF THERE WAS A MALFUNCTION WITH ELECTROSURGICAL PEN AS THAT ACTIVATED ITSELF OR IF THE STAFF ACTIVATED IT WITHOUT NOTICING BECAUSE THE ENERGY ALARM SOUND WAS TOO LOW ON THE GENERATOR.¿. THE PROCEDURE WAS COMPLETED WITHOUT THE USE OF AN ALTERNATE DEVICE. THERE WAS A DELAY OF ¿30+ MINUTES¿. FURTHER INFORMATION HAS BEEN REQUESTED; HOWEVER, TO DATE, A REPLY HAS NOT BEEN RECEIVED. THIS REPORT IS BEING RAISED DUE TO THE REPORTED INJURY OF SLIGHT IMPAIRMENTS.

  Patient problems: Insufficient Information

  MAUDE report 21737687 ↗
• MalfunctionOct 28, 2024Material Fragmentation; Material Fragmentation

  THE SALES REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER THAT THE DEVICE, PLPUL2020, ULTRA SURGICAL SMOKE EVACUATION PENCIL, WAS BEING USED DURING A TOTAL KNEE PROCEDURE ON (B)(6) 2024 WHEN IT WAS REPORTED, ¿SMOKE PENCIL PLASTIC ENCAPSULATION TIP BROKE DURING THE CASE. SHARDS ENDED UP IN PATIENT. ALL REMOVED.". THERE WAS NO REPORT OF INJURY, MEDICAL INTERVENTION, OR HOSPITALIZATION FOR THE PATIENT. THE PROCEDURE WAS COMPLETED WITH AN ALTERNATE DEVICE CAUSING A 10-MINUTE DELAY. THE PATIENT RECEIVED ADDITIONAL WASHINGS. 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 20545258 ↗