PlumePen PLP2520Recalls & reported problems

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 10845854061305), received between Jul 13, 2023 and Apr 16, 2025 — classified as 4 injuries, 16 malfunctions.

The most frequently reported specific device problem is “Self-Activation or Keying” (13 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 20 most recent of 20 reports, in the reporter's own words as published by the FDA.

• InjuryApr 16, 2025Self-Activation or Keying; Self-Activation or Keying

  A SALES REPRESENTATIVE REPORTED ON BEHALF OF A CUSTOMER THAT THE PLP2520, ELITE SURGICAL SMOKE EVAC PENCIL,7/8" (22MM),15FT. (4.6M) DEVICE WAS USED IN AN UNNAMED PROCEDURE ON (B)(4) 2025, AND ¿PLUMEPEN ELITE PLP2520 THAT CAME ON IN THE HOLSTER AND BURNED A PATIENT. THEY SAID BIOMED IS CURRENTLY CHECKING ALL THEIR ESUS TO RULE OUT POSSIBLE MACHINE MALFUNCTION. THE RN MENTIONED A PROLONGED ACTIVATION WARNING FROM THE UNIT AND THAT IS WHEN THEY NOTICED A BURN FROM WHERE THE PEN HAD BEEN RESTING ON THE PATIENT.¿. FURTHER ASSESSMENT WAS ATTEMPTED, AND A GOOD FAITH EFFORT WAS MADE TO OBTAIN FURTHER INFORMATION; HOWEVER, NO RESPONSE HAS BEEN RECEIVED TO DATE. THIS REPORT IS BEING RAISED ON THE BASIS OF THE REPORTED INJURY OF A BURN OF UNKNOWN DEGREE TO A PATIENT.

  Patient problems: Burn(s)

  MAUDE report 21850640 ↗
• InjuryApr 11, 2025Unintended Power Up; Unintended Power Up

  THE CUSTOMER REPORTED THAT THE DEVICE PLP2520, ELITE SURGICAL SMOKE EVAC PENCIL,7/8" (22M 15FT. (4.6M), WAS BEING USED DURING AN ORTHO SPINE PROCEDURE ON APPROXIMATELY (B)(6)2025 WHEN IT WAS REPORTED ¿PLP2520 ACTIVATED ELECTRO SURGERY MODE WHEN NOT BEING TOUCHED (SHORTED OUT) ITEM WAS BEING USED WITH A LAB FT10 SYSTEM. PATIENT RECEIVED A BURN THAT WAS ATTENDED TO AT THE TIME OF THE SURGERY. NO INJURY UPDATE AVAILABLE.¿. FURTHER ASSESSMENT WAS ATTEMPTED, AND A GOOD FAITH EFFORT WAS COMPLETED WITH NO INFORMATION FOUND. THE PROCEDURE WAS COMPLETED WITH A SHORT DELAY AND THE SAME ALTERNATE DEVICE WAS USED. THERE WAS NO REPORT OF MEDICAL INTERVENTION OR EXTENDED HOSPITALIZATION FOR THE PATIENT OR USER. THIS REPORT IS BEING RAISED ON THE REPORTED INJURY DUE TO THE PATIENT RECEIVING AN UNKNOWN DEGREE OF BURN.

  Patient problems: Burn(s)

  MAUDE report 21824318 ↗
• MalfunctionApr 4, 2025Self-Activation or Keying; Self-Activation or Keying

  A CUSTOMER REPORTED THAT THE PLP2520, ELITE SURGICAL SMOKE EVAC PENCIL,7/8" (22MM),15FT. (4.6M) DEVICE WAS USED IN A PROCEDURE ON APPROXIMATELY ON (B)(6) 2025, AND ¿BIO-MED REPORTED DURNING SURGERY ITEM: PLP2520 ACTIVATED ELECTRO SURGERY MODE WHEN NOT BEING TOUCHED (SHORTED OUT) ITEM WAS BEING USED WITH A LAB FT10 SYSTEM. BIO-MED REPLICATED THE PROBLEM USING SAME PEN WITH DIFFERENT LAB FT10.¿. THE PROCEDURE WAS COMPLETED WITH THE USE OF A ¿DIFFERENT PEN USED FROM SAME LOT NOT ISSUE¿ AND A DELAY OF 5 MINUTES. THERE WAS NO IMPACT TO THE 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 21772865 ↗
• MalfunctionOct 1, 2024Unintended Electrical Shock; Unintended Electrical Shock

  THE CUSTOMER REPORTED THAT THE DEVICE, PLP2520, ELITE SURGICAL SMOKE EVAC PENCIL,7/8" (22MM),15FT. (4.6M), WAS BEING USED DURING A LIVER TRANSPLANT PROCEDURE ON (B)(6) 2024 WHEN IT WAS REPORTED, ¿A PLUME PEN DIATHERMY SHORT CIRCUITED DURING SURGERY. WE WERE DOING A LIVER TRANSPLANT SURGERY WHEN DURING THE PROCEDURE, THE SURGEON'S DIATHERMY PEN SHORT CIRCUITED. THE OPERATING SURGEON WHO WAS USING THE DIATHERMY PEN FELT A SMALL SHOCK AFTER THE USE.¿ THERE WAS NO REPORT OF INJURY, MEDICAL INTERVENTION, OR HOSPITALIZATION FOR THE PATIENT OR USER. THE PROCEDURE WAS COMPLETED AS PLANNED TO USE AN ALTERNATE SAME DEVICE. THERE WAS NO REPORT OF ANY PROCEDURE DELAYS. 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 20342820 ↗
• InjuryMay 1, 2024Self-Activation or Keying; Self-Activation or Keying

  A SALES REPRESENTATIVE REPORTED ON BEHALF OF A CUSTOMER THAT THE PLP2520, PLUMEPEN ELITE SURGICAL SMOKE EVAC PENCIL, 15FT TUBING,QTY20 DEVICE WAS BEING USED DURING AN INSERTION SPINAL CORD STIMULATOR PROCEDURE ON (B)(6) 2024, AND ¿PENCIL WAS NOT ACTIVELY BEING USED, WAS SITTING ON STERILE FIELD. SURGEON WAS BURNED BY PENCIL THROUGH GOWN, CUTTING/BURNING ARM. NO SOUND FROM CAUTERY MACHINE NOTED. PENCIL WAS OUT OF SIDE PACK¿. FOLLOW-UP ASSESSMENT FOUND THE USER HAD SUSTAINED A "2ND DEGREE BURN AS WELL AS A CUT" TO THE RIGHT FOREARM, AND THAT THE DEVICE "HAD BEEN USED (ACTIVATED) AND WAS SET DOWN NOT CURRENTLY IN USE". THE CUSTOMER OPINED THAT THE DEVICE "APPARENTLY" SELF-ACTIVATED, AS "PLENTY OF TIME PASSED FOR IT TO COOL DOWN". THE PROCEDURE WAS COMPLETED WITH REGULAR CAUTERY AND NO DELAY. IT WAS CONFIRMED THAT "NO INTERVENTION OR HOSPITALIZATION WAS REQUIRED. THEY DID DRAW A HIV AND HEPATITIS PANEL FROM THE PATIENT PER OUR POLICY.". THIS REPORT IS BEING RAISED DUE TO THE REPORTED INJURY OF A SECOND DEGREE BURN AND LACERATION TO THE USER.

  Patient problems: Laceration(s); Partial thickness (Second Degree) Burn

  MAUDE report 19220910 ↗
• MalfunctionApr 1, 2024Self-Activation or Keying; Self-Activation or Keying

  THE DISTRIBUTOR REPORTED ON BEHALF OF THEIR CUSTOMER THAT THE DEVICE, PLP2520, PLUMEPEN ELITE SURGICAL SMOKE EVAC PENCIL, 15FT TUBING,QTY20, WAS BEING USED DURING AN UNKNOWN PROCEDURE ON AN UNKNOWN WHEN IT WAS REPORTED, ¿DEFECTIVE CAUTERY PENCIL..¿ FURTHER ASSESSMENT QUESTIONS FOUND THAT THE CAUTERY PENCIL WAS ACTIVATED WHILE IN THE HOLSTER. THE PROCEDURE WAS COMPLETED WITH NO REPORT OF DELAY. THERE WAS NO REPORT OF INJURY, MEDICAL INTERVENTION, OR 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 19010408 ↗
• MalfunctionApr 1, 2024Self-Activation or Keying; Self-Activation or Keying

  THE DISTRIBUTOR REPORTED ON BEHALF OF THEIR CUSTOMER THAT THE DEVICE, PLP2520, PLUMEPEN ELITE SURGICAL SMOKE EVAC PENCIL, 15FT TUBING,QTY (B)(4) , WAS BEING USED DURING AN UNKNOWN PROCEDURE ON AN UNKNOWN WHEN IT WAS REPORTED, ¿DEFECTIVE CAUTERY PENCIL..¿ FURTHER ASSESSMENT QUESTIONS FOUND THAT THE CAUTERY PENCIL WAS ACTIVATED WHILE IN THE HOLSTER. THE PROCEDURE WAS COMPLETED WITH NO REPORT OF DELAY. THERE WAS NO REPORT OF INJURY, MEDICAL INTERVENTION, OR 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 19010407 ↗
• MalfunctionApr 1, 2024Power Problem; Power Problem

  THE DISTRIBUTOR REPORTED ON BEHALF OF THE CUSTOMER THAT THE PLP2520 WAS BEING USED AND THE "CAUTERY UNIT STAYED ON". THERE WAS NO REPORT OF IMPACT/INJURY, MEDICAL INTERVENTION, OR EXTENDED HOSPITALIZATION 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 19010331 ↗
• MalfunctionMar 25, 2024Mechanical Jam; Mechanical Jam

  THE SALES REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER THAT THE PLP2520, PLUMEPEN ELITE SURGICAL SMOKE EVAC PENCIL, 15FT TUBING, QTY20 WAS BEING USED ON 5MAR24 DURING A TOTAL HIP ARTHROPLASTY AND ¿CUT BUTTON STUCK ON THE PLUMEPEN ELITE PENCIL. THE BUTTON WAS NO LONGER BEING PRESSED BUT REMAINED STUCK DOWN. THIS MEANT THAT THE ESU CONTINUED TO RUN AND DELIVER ENERGY EVEN THOUGH THE BUTTON WAS NOT BEING PRESSED. FORTUNATELY, THERE WAS NO PATIENT BURN THAT OCCURRED IN THIS CASE. HOWEVER, THIS COULD HAVE CAUSED A VERY SERIOUS PATIENT SAFETY ISSUE¿. THERE WAS NO IMPACT OR INJURY TO THE PATIENT OR USER. THE PROCEDURE WAS COMPLETED WITH AN ALTERNATE UNKNOWN DEVICE. 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 18969709 ↗
• MalfunctionMar 25, 2024Self-Activation or Keying; Self-Activation or Keying

  THE SALES REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER, THAT THE PLP2520 PLUMEPEN ELITE SURGICAL SMOKE EVAC PENCIL, 15FT TUBING WAS BEING USED DURING AN UNKNOWN PROCEDURE ON (B)(6) 2024 WHEN IT WAS REPORTED ¿SURGEON PICKED UP CAUTERY DEVICE AND NOTED THAT THE DEVICE WAS ON PRIOR TO PUSHING BUTTON ON DEVICE. SCRUB TECH NOTED THAT IT SEEMS THAT THE CAUTERY COAG BUTTON WAS STUCK. DEVICE REMOVED FROM FIELD AND PLACED IN A RED BAG.¿. THE PROCEDURE WAS COMPLETED AND THERE WAS NO REPORT OF INJURY, MEDICAL INTERVENTION, OR EXTENDED HOSPITALIZATION TO THE 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 18969151 ↗
• MalfunctionMar 25, 2024Self-Activation or Keying; Self-Activation or Keying

  THE SALES REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER, THAT THE PLP2520 PLUMEPEN ELITE SURGICAL SMOKE EVAC PENCIL, 15FT TUBING WAS BEING USED DURING A SPINE FUSION PROCEDURE ON (B)(6) 2024 DATE WHEN IT WAS REPORTED ¿STAFF IN ROOM HEARD A HIGH PITCHED NOISE. WHEN INVESTIGATING THEY NOTICED THAT THE CAUTERY POWER WAS ON. THEY CHECKED TO MAKE SURE THE NOTHING WAS PRESSING ON THE BUTTON IT WAS DETERMINED THAT NOTHING WAS PRESSING ON THE BUTTON. STAFF IMMEDIATELY REMOVED THE CAUTERY FROM THE FIELD. NEURO MONITORING WASN¿T USED.¿. THERE WAS NO REPORT OF INJURY, MEDICAL INTERVENTION, OR EXTENDED HOSPITALIZATION TO THE 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 18967621 ↗
• MalfunctionMar 22, 2024Self-Activation or Keying; Self-Activation or Keying

  THE CUSTOMER REPORTED THAT THE PLP2520, PLUMEPEN ELITE SURGICAL SMOKE EVAC PENCIL, 15FT TUBING,QTY20 WAS BEING USED ON (B)(6) 2024 DURING A LAMINECTOMY AND THE ¿STAFF IN ROOM HEARD HIGH PITCH NOISE. AFTER INVESTIGATING IT WAS NOTED THAT THE CAUTERY PENCIL WAS ACTIVATED WHILE IN HOLSTER. PENCIL REMOVED FROM FIELD.¿. THERE WAS NO IMPACT OR INJURY TO THE PATIENT. THE PROCEDURE WAS COMPLETED WITH A 2 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 18957930 ↗
• MalfunctionMar 22, 2024Self-Activation or Keying; Self-Activation or Keying

  THE CUSTOMER REPORTED THAT THE PLP2520, PLUMEPEN ELITE SURGICAL SMOKE EVAC PENCIL, 15FT TUBING,QTY20 WAS BEING USED OM 1MAR24 DURING A LUMBAR LAMINECTOMY AND "THE BIPOLAR ELECTROCAUTERY WS NOT WORKING. THEY CHANGED THE BIPOLAR CORD AND NOTICED THAT IT STILL WASN'T WORKING. AFTER FURTHER INVESTIGATION IT WAS RECOGNIZED THAT THE CAUTERY WAS STILL ACTIVATED. BIPOLAR WILL NOT WORK IF CAUTERY IS ACTIVATED. CAUTERY PENCIL WAS IN THE PROTECTIVE HOLSTER AND NOT TO BE USED AT THIS TIME. CAUTERY PENCIL WAS REMOVED FROM THE FILED. A NEW PENCIL WAS GIVEN. AT THAT TIME THE BIPOLAR STARTED WORKING.¿. THERE WAS NO IMPACT OR INJURY TO THE PATIENT. THE PROCEDURE WAS COMPLETED. 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 18957929 ↗
• MalfunctionMar 21, 2024Self-Activation or Keying; Self-Activation or Keying

  THE SALES REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER THAT THE DEVICE, PLP2520, PLUME PEN ELITE SURGICAL SMOKE EVAC PENCIL, 15FT TUBING,QTY 20, WAS BEING USED DURING A LAMINECTOMY PROCEDURE ON (B)(6) 2024 WHEN IT WAS REPORTED, ¿STAFF IN ROOM HEARD A HIGH-PITCHED NOISE. WHILE INVESTIGATING THEY NOTICED THAT THE CAUTERY PENCIL WAS ON. THEY CHECKED TO MAKE SURE NOTHING WAS PRESSING ON THE BUTTON. IT WAS DETERMINED THAT NOTHING WAS PRESSING ON THE BUTTON. STAFF IMMEDIATELY REMOVED THE CAUTERY FROM THE FIELD.". THERE WAS NO REPORT OF MEDICAL INTERVENTION OR HOSPITALIZATION FOR THE PATIENT. THE PROCEDURE WAS COMPLETED AS PLANNED WITHOUT REPORT OF 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 18948347 ↗
• MalfunctionMar 18, 2024Self-Activation or Keying; Self-Activation or Keying

  THE SALES REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER THAT THE PLP2520, PLUMEPEN ELITE SURGICAL SMOKE EVAC PENCIL, 15FT TUBING,QTY20, WAS BEING USED DURING A SPINE FUSION PROCEDURE ON (B)(6) 2024 WHEN IT WAS REPORTED, ¿DURING A SCHEDULED PROCEDURES THE CORDS TO THE EQUIPMENT WERE THROWN OFF THE STERILE FIELD TO BE PLUGGED IN. THE BOVIE WAS PLUGGED INTO THE CAUTERY MACHINE. WHEN THE RN WENT TO PLUG THE DRILL IN HIS FINGER ON HIS LEFT HAND WAS BURNED. THE BOVIE WAS IN THE ON SETTING WITHOUT THE BUTTON BEING PUSHED BY THE SURGEON. THE BOVIE TIP WAS IN CONTACT WITH THE DRILL AT THE TIME IT WAS BEING PLUGGED IN. THIS CASE WAS USING NEUROMONITORING. WHEN THE BOVIE IS ON, NEUROMONITORING CAN PICK UP THE ELECTRICITY ON THEIR MACHINE. THEY NOTICED THERE WAS A LOT OF ARTIFACTS ON THEIR MACHINE AND ASKED THE NURSE TO CHECK THE CAUTERY. THIS IS WHEN HE WENT TO PLUG IN THE DRILL AND BURNT HIS HAND ON THE PLUG IN. WHEN CAUTERY WAS UNPLUGGED THE ARTIFACT ON THE NEUROMONITORING SUBSIDED.". THERE WAS NO REPORT OF MEDICAL INTERVENTION OR HOSPITALIZATION FOR THE USER. FURTHER ASSESSMENT QUESTIONING FOUND THAT THE REPORT ADVISED, ¿THE WOMAN¿S FINGER WAS RED, BUT IT WAS NOT A SERIOUS BURN.¿ THIS

  Patient problems: Burn(s)

  MAUDE report 18920402 ↗
• MalfunctionMar 14, 2024Self-Activation or Keying; Self-Activation or Keying

  THIS COMPLAINT WAS CREATED DUE TO THE RECEIPT OF A MEDWATCH REPORT (B)(4) ON 23FEB24. THE REPORT WAS FOUND TO BE WRITTEN AGAINST PLP2520, PLUMEPEN ELITE SURGICAL SMOKE EVAC PENCIL, THAT WAS BEING USED DURING AN UNKNOWN PROCEDURE ON (B)(6) 2024. THE REPORT STATED, ¿DURING SURGICAL PROCEDURE, THE CAUTERY BUTTON REMAINED DEPRESSED AND NOTED TO BE DEFECTIVE. THE DEVICE WAS SEQUESTERED. THIS IS THE THIRD OR FOURTH OF THESE EVENTS THAT HAVE OCCURRED RECENTLY IN OUR OR.¿ 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 ON THE REPORTED MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18904926 ↗
• MalfunctionMar 12, 2024Self-Activation or Keying; Self-Activation or Keying

  A SALES REPRESENTATIVE REPORTED ON BEHALF OF A CUSTOMER THAT THE PLP2520, PLUMEPEN ELITE SURGICAL SMOKE EVAC PENCIL, 15FT TUBING,QTY20 DEVICE WAS BEING USED DURING A REMOVAL SPINE HARDWARE PROCEDURE ON (B)(6) 2024, AND ¿CAUTERY PENCIL REMAINED ACTIVE EVEN WHEN BUTTONS NOT PUSHED. SCRUB TECH NOTICED THE HIGH PITCH NOISE THE CAUTERY MACHINE MAKES AND WAS MADE AWRE THAT THE MACHINE WAS ACTIVATED. SURGEON WENT TO USE THE CAUTERY AT THE SAME TIME AND NOTICED IT WAS ALREADY ACTIVATED PRIOR TO HIM PUCHING THE BUTTON. THIS CAUTERY PENCIL DID NOT COME INSIDE THE SPINE PACK. IT WAS PULLED FROM THE SUPPLY SHELF¿. THE PROCEDURE WAS COMPLETED WITH A SECOND ELITE PENCIL AND NO REPORTED DELAY. 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 18889219 ↗
• InjuryMar 6, 2024Break; Break

  THE SALES REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER, THAT THE PLP2520 PLUMEPEN ELITE SURGICAL SMOKE EVAC PENCIL, 15FT TUBING, QTY (B)(4) WAS BEING USED DURING AN UNKNOWN PROCEDURE ON (B)(6) 2024 DATE WHEN IT WAS REPORTED ¿THE BUTTON BROKE ON THE PENCIL CAUSING IT TO REMAIN ON, PATIENT BURNED.¿ FURTHER ASSESSMENT QUESTIONS WERE REQUESTED OF THE REPORTER AND A GOOD FAITH EFFORT WAS COMPLETED; HOWEVER, THE REPORTER HAS NOT RESPONDED TO OUR ATTEMPTS FOR INFORMATION. THERE WAS NO REPORT OF MEDICAL INTERVENTION OR EXTENDED HOSPITALIZATION TO THE PATIENT OR USER. THIS REPORT IS BEING RAISED ON REPORTED INJURY DUE TO UNKNOWN DEGREE OF BURN.

  Patient problems: Burn(s)

  MAUDE report 18844713 ↗
• MalfunctionMar 6, 2024Mechanical Jam; Mechanical Jam

  THE SALES REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER, THAT THE PLP2520 PLUMEPEN ELITE SURGICAL SMOKE EVAC PENCIL, 15FT TUBING, QTY (B)(4) WAS BEING USED DURING AN UNKNOWN PROCEDURE ON 08FEB24 DATE WHEN IT WAS REPORTED THE BUTTON BROKE ON THE PENCIL CAUSING IT TO REMAIN ON, NO INJURY.. THERE WAS NO REPORT OF INJURY, MEDICAL INTERVENTION OR EXTENDED HOSPITALIZATION TO 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 18844666 ↗
• MalfunctionJul 13, 2023Melted; Melted

  THE SALES REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER THAT THE PLP2520, PLUMEPEN ELITE SURGICAL SMOKE EVAC PENCIL, 15FT TUBING,QTY20, WAS BEING USED DURING A OPEN LIVER RESECTION PROCEDURE ON (B)(6) 2023 WHEN IT WAS REPORTED, ¿FINGERSWITCH DIATHERMY STANDARD POWER SETTING 60 TIP MELTED AWAY. THE SURGEON WAS ACTUALLY HARMED TODAY AND BURNT HIS FINGER, THIS WAS ALSO WHILST CUTTING THROUGH ABDOMINAL MUSCLE.¿. THERE WAS NO REPORT OF MEDICAL INTERVENTION OR HOSPITALIZATION FOR THE USER OR PATIENT. THE PROCEDURE WAS COMPLETED AS PLANNED. FURTHER ASSESSMENT QUESTIONING FOUND THAT THE SURGEON SUSTAINED A 1ST DEGREE BURN WITH NO MEDICAL INTERVENTION OR HOSPITALIZATION. THE PROCEDURE CARRIED ON AS NORMAL. THIS REPORT IS BEING RAISED DUE TO THE REPORTED MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

  Patient problems: Superficial (First Degree) Burn

  MAUDE report 17315038 ↗