PlumePen PLP2020Recalls & reported problems

Summary

The FDA's MAUDE database contains 50 adverse event reports that list this exact device (DI 10845854061282), received between Mar 21, 2022 and Sep 10, 2026 — classified as 10 injuries, 40 malfunctions.

The most frequently reported specific device problem is “Device Remains Activated” (16 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 25 most recent of 50 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 10, 2026Unintended Electrical Shock

  Patient problems: Electric Shock

  MAUDE report 50713267 ↗
• 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 ↗
• MalfunctionDec 15, 2025Material Fragmentation; Material Fragmentation

  THE DISTRIBUTOR REPORTED ON BEHALF OF THEIR CUSTOMER THAT THE PLP2020 ELITE SURGICAL SMOKE EVACUATION PENCIL, DEVICE WAS BEING USED ON (B)(6) 2025 DURING AN UNKNOWN PROCEDURE WHEN IT WAS REPORTED WAS REPORTED ¿DURING THE INITIAL EXPOSURE FOR THE POSTERIOR CERVICAL FUSION, THE SURGEON OBSERVED THE PROTECTIVE INSULATION OF THE ELECTROCAUTERY TIP SLIP OFF INTO THE SURGICAL SITE, PLP2020 THE PIECE WAS IMMEDIATELY REMOVED AND A REPLACEMENT OPENED. THERE WAS NO REPORT OF INJURY, 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 23801705 ↗
• InjuryDec 10, 2025Material Fragmentation; Material Fragmentation

  THIS COMPLAINT WAS CREATED DUE TO THE RECEIPT OF A MEDWATCH REPORT (MW5178497) RECEIVED ON 24NOV2025. A SEARCH OF THE COMPLAINT SYSTEM HAS NOT FOUND A COMPLAINT REPORTED FOR THIS DEVICE DURING THIS TIMEFRAME. THE REPORT WAS FOUND TO BE WRITTEN AGAINST THE PLP2020, ELITE SURGICAL SMOKE EVACUATION PENCIL. THE INCIDENT OCCURRED ON (B)(6) 2025. THE REPORT STATES THAT THE ¿SMOKE EVAC PENCIL PLASTIC SHEATH BROKE INTO PIECES DURING SURGERY. SURGEONS HAD TO STOP AND FIND PIECES.¿ THE HEALTH EFFECT - CLINICAL CODE WAS REPORTED AS 4580: INSUFFICIENT INFORMATION. IT WAS NOT REPORTED IF ALL THE PIECES WERE SUCCESSFULLY REMOVED FROM THE PATIENT AND AS THE REPORTER ELECTED TO REMAIN ANONYMOUS, THIS INFORMATION CANNOT BE OBTAINED. THIS REPORT IS BEING RAISED DUE TO THE REPORTED INJURY OF POSSIBLE RETAINED FOREIGN BODY.

  Patient problems: Foreign Body In Patient

  MAUDE report 23766946 ↗
• InjuryAug 19, 2025Material Fragmentation; Material Fragmentation

  THIS COMPLAINT WAS CREATED BY THE FINDING OF MAUDE REPORT NUMBER MW5171145. THE ACCOUNT AND CONTACT INFORMATION FOR THIS REPORT ARE NOT KNOWN. THE CURRENT COMPLAINT DATABASE HAS BEEN RESEARCHED FOR THIS EVENT AND THERE WERE NO FINDINGS. THE PLP2020, ELITE SURGICAL SMOKE EVACUATION PENCIL WAS BEING USED ON (B)(6) 2025 AND THE ¿SMOKE EVACUATOR BOVIE PENCIL BROKE DURING PROCEDURE. PLASTIC PIECE THAT SUCTIONS SMOKE BROKE A SMALL PIECE OF PLASTIC WAS FOUND BUT ANOTHER PIECE WAS NOT FOUND.¿. THE REPORTER ELECTED TO REMAIN ANONYMOUS; THEREFORE, NO FURTHER INFORMATION CAN BE OBTAINED REGARDING THE EVENT. THIS REPORT IS BEING RAISED DUE TO THE REPORTED INJURY OF ¿PIECE OF PLASTIC WAS NOT FOUND¿ THAT MAY POTENTIALLY REMAIN IN THE PATIENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 22840588 ↗
• InjuryJul 24, 2025Material Fragmentation; Material Fragmentation

  A DISTRIBUTOR REPORTED ON BEHALF OF A CUSTOMER THAT THE PLP2020, ELITE SURGICAL SMOKE EVACUATION PENCIL DEVICE WAS USED IN AN UNKNOWN PROCEDURE ON (B)(6) 2025, AND ¿PLASTIC PIECE THAT SUCTIONS SMOKE BROKE OFF HANDPIECE. NO INJURIES.¿. THE PROCEDURE WAS COMPLETED WITH THE USE OF AN ALTERNATE DEVICE AND ¿NO SIGNIFICANT DELAY¿. FURTHER ASSESSMENT FOUND IT IS UNKNOWN WHETHER ANY FRAGMENT OR COMPONENT FELL INTO THE SURGICAL SITE. THERE WAS NO REPORT OF INJURY, MEDICAL/SURGICAL INTERVENTION, OR EXTENDED HOSPITALIZATION FOR THE PATIENT. THIS REPORT IS BEING RAISED DUE TO THE INJURY OF A POSSIBLE RETAINED FOREIGN BODY.

  Patient problems: Foreign Body In Patient

  MAUDE report 22586084 ↗
• MalfunctionMar 12, 2025Crack; Energy Output Problem; Crack; Energy Output Problem

  THE CUSTOMER REPORTED THAT THE PLP2020, ELITE SURGICAL SMOKE EVACUATION PENCIL, WAS BEING USED ON (B)(6) 2025 DURING A BREAST RECONSTRUCTION PROCEDURE WHEN IT WAS REPORTED ¿THE TOP OF THE HANDPIECE IS SPLIT, AND THE CURRENT GOES THROUGH THE DIATHERMY HANDPIECE PART, INSTEAD OF THE TIP OF THE INSULATED DIATHERMY. IT CAUSES UNWANTED/ACCIDENTAL BURNS/DIATHERMY OVER THE OPERATED AREA. THIS HAPPENED MORE THAN ONCE.¿. FURTHER ASSESSMENT QUESTIONING FOUND THAT ¿THE BURN WAS OBTAINED ON THE PATIENT¿S SKIN RIGHT NEXT TO THE INCISION AND WAS DIAGNOSED AS A 1ST DEGREE BURN." THE DEVICE ALSO DID NOT PRODUCE ANY FIRE, FLAMES OR ARCHING. THE PROCEDURE WAS COMPLETED AND THERE WAS NO REPORT OF INJURY, MEDICAL INTERVENTION, OR EXTENDED HOSPITALIZATION FOR THE PATIENT OR USER. THE CURRENT STATUS OF THE PATIENT WAS REPORTED AS ¿HEALTHY¿. THIS REPORT IS BEING RAISED DUE TO THE REPORTED MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

  Patient problems: Superficial (First Degree) Burn

  MAUDE report 21587619 ↗
• MalfunctionFeb 6, 2025Adverse Event Without Identified Device or Use Problem; Unintended Electrical Shock; Adverse Event Without Identified Device or Use Problem; Unintended Electrical Shock

  THE CUSTOMER REPORTED THAT THE PLP2020, ELITE SURGICAL SMOKE EVACUATION PENCIL, WAS BEING USED ON (B)(6) 2025 DURING A TONSILLECTOMY PROCEDURE WHEN IT WAS REPORTED ¿NO PATIENT IMPACT BUT PHYSICIAN DID GET SHOCKED IN THE HAND. HE DID DOUBLE CHECK HIS GLOVE AND NO HOLE IN HIS GLOVE.¿ FURTHER ASSESSMENT QUESTIONING FOUND ¿ALL INVOLVED ARE FINE.¿. 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 21321106 ↗
• MalfunctionAug 21, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  THIS COMPLAINT WAS CREATED DUE TO THE RECEIPT OF (B)(4). THE CURRENT COMPLAINT DATABASE HAS BEEN RESEARCHED FOR THIS EVENT AND THERE WERE NO FINDINGS. THE REPORT WAS FOUND TO BE WRITTEN AGAINST DEVICE, PLP2020, PLUMEPEN ELITE SURGICAL SMOKE EVAC PENCIL, 10FT TUBING,QTY20. THE REPORT STATED, ¿THE CONSULTANT SURGEON WAS USING THE DIATHERMY ON THE COAGULATION AND GOT A SMALL ELECTRIC SHOCK.¿. THERE WAS NO REPORT OF INJURY, MEDICAL INTERVENTION, OR HOSPITALIZATION FOR THE PATIENT. THIS REPORT IS BEING RAISED DUE TO THE REPORTED MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

  Patient problems: Electric Shock

  MAUDE report 20020182 ↗
• MalfunctionJul 9, 2024Device Remains Activated; Device Remains Activated

  A DISTRIBUTOR REPORTED ON BEHALF OF A CUSTOMER THAT THE PLP2020, PLUMEPEN ELITE SURGICAL SMOKE EVAC PENCIL, 10FT TUBING,QTY20 DEVICE WAS BEING USED ON 30MAY24, AND THE ¿BOVIE WOULD NOT SHUT OFF¿. FURTHER ASSESSMENT FOUND THE EVENT OCCURRED DURING A "SPINE PROCEDURE (NOT SPECIFIED)". AN UNKNOWN ALTERNATE DEVICE WAS USED AND THERE WAS NO REPORTED DELAY TO THE PROCEDURE. THERE WAS NO INJURY TO THE PATIENT OR USER, AND NO MEDICAL/SURGICAL INTERVENTION OR EXTENDED HOSPITALIZATION WAS REQUIRED 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 19704889 ↗
• MalfunctionMay 15, 2024Self-Activation or Keying; Mechanical Jam; Self-Activation or Keying; Mechanical Jam

  THE SALES REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER THAT THE PLP2020, PLUMEPEN ELITE SURGICAL SMOKE EVAC PENCIL, 10FT TUBING,QTY (B)(4) WAS BEING USED ON 29APR24 DURING A TOTAL JOINT PROCEDURE AND THE ¿PENCIL IS STICKING AND CONTINUES TO FIRE." PER FURTHER ASSESSMENT IT WAS FOUND THAT THE PENCIL KEPT ACTIVATING AND THE SURGERY WAS COMPLETED NORMALLY USING A DIFFERENT PENCIL. THERE WAS NO REPORT OF 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 19322533 ↗
• MalfunctionMay 15, 2024Self-Activation or Keying; Mechanical Jam; Self-Activation or Keying; Mechanical Jam

  THE SALES REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER THAT THE PLP2020, PLUMEPEN ELITE SURGICAL SMOKE EVAC PENCIL, 10FT TUBING,QTY20 WAS BEING USED DURING A TOTAL JOINT PROCEDURE AND THE ¿PENCIL IS STICKING AND CONTINUES TO FIRE." PER FURTHER ASSESSMENT IT WAS FOUND THAT THE PENCIL KEPT ACTIVATING AND THE SURGERY WAS COMPLETED NORMALLY USING A DIFFERENT PENCIL. THERE WAS NO REPORT OF 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 19322523 ↗
• MalfunctionMay 8, 2024Power Problem; Power Problem

  CONMED JAPAN REPORTED ON BEHALF OF THE CUSTOMER THAT THE PLP2020 - PLUMEPEN ELITE SURGICAL SMOKE EVAC PENCIL, 10FT TUBING, QTY20, WAS BEING USED (B)(6) 2024 AND THE "OUTPUT DID NOT WORK WELL¿. IT WAS REPORTED THAT THIS EVENT OCCURRED DURING SURGERY WITH NO IMPACT TO THE PATIENT. THE DEVICE EVALUATION REVEALED THAT "THE COAGULATION CONTINUOUSLY ACTIVATES WITHOUT PRESSING THE BUTTON.". 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 19267672 ↗
• MalfunctionMar 28, 2024Material Fragmentation; Material Fragmentation

  THE DISTRIBUTOR REPORTED ON BEHALF OF THEIR CUSTOMER THAT THE DEVICE, PLP2020, PLUMEPEN ELITE SURGICAL SMOKE EVAC PENCIL, 10FT TUBING,QTY (B)(4), WAS BEING USED DURING A LUMBAR FUSION PROCEDURE ON (B)(6) 2024 WHEN IT WAS REPORTED, ¿CAUTERY TIP BROKE DURING USE.¿ FURTHER ASSESSMENT QUESTIONS FOUND THAT THE PROCEDURE WAS COMPLETED WITH A 5-MINUTE DELAY. A FRAGMENT HAD FALLEN INTO THE PATIENT WHEN THE ASSISTANT WAS WIPING OFF THE TIP OF THE DEVICE AND THE TIP FRACTURED. THE FRAGMENTATION WAS REMOVED WITH ¿PICK-UPS.¿. 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 18990991 ↗
• MalfunctionMar 19, 2024Device Remains Activated; Device Remains Activated

  THE SALES REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER THAT THE DEVICE, PLP2020, PLUMEPEN ELITE SURGICAL SMOKE EVAC PENCIL, 10FT TUBING,QTY20, WAS BEING USED DURING AN UNKNOWN PROCEDURE ON 15OCT23 WHEN IT WAS REPORTED, ¿CAUTERY BUTTON STAYED DEPRESSED - COULD NOT TURN OFF.". THERE WAS NO REPORT OF MEDICAL INTERVENTION OR HOSPITALIZATION FOR THE PATIENT. THE PROCEDURE WAS COMPLETED AS PLANNED USING AN ALTERNATE SAME 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 18928994 ↗
• MalfunctionMar 19, 2024No Device Output; No Device Output

  THE CUSTOMER REPORTED THAT THE PLP2020, PLUMEPEN ELITE SURGICAL SMOKE EVAC PENCIL, 10FT TUBING,QTY20, WAS BEING USED DURING AN UNKNOWN PROCEDURE ON (B)(6) 2024 WHEN IT WAS REPORTED, ¿IT WAS REPORTED AS ADDITIONAL INFORMATION THAT COAG DID NOT OUTPUT.¿. THERE WAS NO REPORT OF INJURY, MEDICAL INTERVENTION, OR HOSPITALIZATION FOR THE PATIENT. HOWEVER, DURING EVALUATION OF THE DEVICE IT WAS DISCOVERED THAT THE DEVICE SELF-ACTIVATED WHEN PLUGGED INTO THE ESU. 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 18928588 ↗
• MalfunctionMar 19, 2024No Device Output; No Device Output

  IT WAS REPORTED BY THE CUSTOMER THAT THE ¿PLP2020 - PLUMEPEN ELITE SURGICAL SMOKE EVAC PENCIL, 10FT TUBING,QTY20, "THAT THE COAG BUTTON WAS BROKEN SO THAT OUTPUT COULD NOT BE USED.¿. IT WAS REPORTED THAT THIS EVENT OCCURRED DURING SURGERY WITH NO IMPACT TO PATIENT. HOWEVER, DURING EVALUATION OF THE DEVICE IT WAS DISCOVERED THAT THE DEVICE SELF-ACTIVATED WHEN PLUGGED INTO THE ESU. 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 18928586 ↗
• InjuryMar 18, 2024Material Fragmentation; Material Fragmentation

  THE CUSTOMER REPORTED THAT THE DEVICE, PLP2020, PLUMEPEN ELITE SURGICAL SMOKE EVAC PENCIL, 10FT TUBING, QTY (B)(4), WAS BEING USED ON (B)(6) 2024 AND ¿ONE OF THE CLEAR PLASTIC PLUME TUBES FELL OFF THE DEVICE WHILE THE SCRUB NURSE WAS PREPARING IT PRIOR TO SURGERY. THE TEAM OPENED ANOTHER ONE WHICH SHE CHECKED AND IT APPEARED TO BE¿. PER FURTHER ASSESSMENT IT WAS FOUND THAT "THE TEAM OPENED ANOTHER ONE WHICH SHE CHECKED AND IT APPEARED TO BE FINE. DURING SURGERY THE SURGEON ALERTED THE SCRUB NURSE THAT THE DIATHERMY HAD FALLEN APART, THE CLEAR PLASTIC TUBE HAD COME AWAY FROM THE MAIN BODY AND ONE OF THE COLLARS WAS MISSING. THE BROKEN DEVICE WAS REPLACED TO COMPLETE THE SURGERY. IT WAS REPLACED BY THE SAME TYPE OF DEVICE WITH THE SAME LOT. THERE WERE NO PROBLEMS WITH THIS DEVICE." IT WAS ALSO FOUND THAT "AFTER SEVERAL HOURS OF OPERATING THE DEVICE FELL APART IN THE SURGEONS HANDS." IT IS UNKNOWN IF THE FRAGMENT FELL INTO THE PATIENT "THE SURGICAL WOUND WAS SEARCHED THOROUGHLY, THE SWABS, DRAPES AND FLOOR WERE ALL SEARCHED BUT THE PIECE OF PLASTIC WAS NOT FOUND. THE PIECE IN QUESTION WAS CLEAR IN COLOUR AND APPROXIMATELY 2MM IN SIZE. THE WOUND WAS A LARGE MIDLINE LAPAROTOMY WOUND. EV

  Patient problems: Foreign Body In Patient

  MAUDE report 18920366 ↗
• MalfunctionMar 14, 2024Fire; Fire

  A SALES REPRESENTATIVE REPORTED ON BEHALF OF A CUSTOMER THAT THE PLP2020, PLUMEPEN ELITE SURGICAL SMOKE EVAC PENCIL, 10FT TUBING,QTY20 DEVICE WAS BEING USED DURING AN UNNAMED PROCEDURE ON (B)(6) 2024, AND ¿CAUTERY HAD FLAMES COMING OUT OF THE TIP WHEN THE SURGEON TRIED TO CAUTERIZE AN ARTERY ON A HEMATOMA. PATIENT WAS NOT HARMED. IMMEDIATELY DISCONTINUED USE OF THE CAUTERY AND USED A NEW ONE.¿. THE PROCEDURE WAS COMPLETED WITH A ¿DIFFERENT 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 18905397 ↗
• MalfunctionFeb 15, 2024Device Remains Activated; Device Remains Activated

  THE CUSTOMER REPORTED THAT THE DEVICE, PLP2020, PLUMEPEN ELITE SURGICAL SMOKE EVAC PENCIL, 10 FT TUBING, QTY (B)(4), DURING A NON-SURGICAL INCIDENT WAS FOUND AS, "BUTTON GOT STUCK WOULD NOT RELEASE." THERE WAS NO REPORT OF INJURY, MEDICAL INTERVENTION, OR 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 18710049 ↗
• MalfunctionFeb 6, 2024Device Remains Activated; Power Problem; Device Remains Activated; Power Problem

  CONMED JAPAN REPORTED ON BEHALF OF THEIR CUSTOMER THAT THE DEVICE, PLP2020, PLUMEPEN ELITE SURGICAL SMOKE EVAC PENCIL, 10FT TUBING,QTY20 WAS BEING USED ON (B)(6) 2024 AND ¿IT WAS REPORTED THAT THE COAG REMAINED IN OUTPUT STATE.¿ FURTHER ASSESSMENT WAS SENT; HOWEVER, NO OTHER INFORMATION WAS KNOWN.¿. THERE WAS NO REPORT OF IMPACT/INJURY, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION 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 18649172 ↗
• InjuryJan 4, 2024Device Remains Activated; Device Remains Activated

  THE SALES REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER, THAT THE PLP2020, PLUMEPEN ELITE SURGICAL SMOKE EVAC PENCIL, 10FT TUBING WAS BEING USED DURING A TOTAL KNEE REPLACEMENT PROCEDURE ON 08DEC23 WHEN IT WAS REPORTED ¿IT WAS "USING A PLUMEPEN ELITE AND THE BUTTONS STUCK AND DID NOT TURN OFF. ENDED UP BURNING THE PATIENT MULTIPLE TIMES.¿. FURTHER ASSESSMENT ANSWERS WERE REQUESTED OF THE REPORTER AND A GOOD FAITH EFFORT WAS COMPLETED; HOWEVER, THE REPORTER HAS NOT RESPONDED TO OUR ATTEMPTS FOR INFORMATION. THE PROCEDURE WAS COMPLETED WITHOUT THE USE OF AN ALTERNATE DEVICE, AND THE CURRENT STATUS OF THE PATIENT WAS REPORTED AS ¿DOING OK BUT DOES HAVE BURNS ON THEM.¿. 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 THE UNKNOWN DEGREE OF PATIENT BURN.

  Patient problems: Burn(s)

  MAUDE report 18448767 ↗
• MalfunctionDec 12, 2023Mechanical Jam; Mechanical Jam

  THE CUSTOMER REPORTED THAT THE PLP2020, PLUMEPEN ELITE SURGICAL SMOKE EVAC PENCIL, 10FT TUBING,QTY20 WAS BEING USED ON (B)(6) 2023 DURING A TOTAL KNEE ARTHROPLASTY PROCEDURE AND ¿AFTER USING THE CAUTERY MECHANISM, TEH CAUTERY FUNCTION REMAINS ON EVEN AFTER THE BUTTON WAS RELEASED. THIS WAS DURING A TOTAL KNEE ANTHROPLASTY WITH DR. ANOTHER DEVICE WAS UTILIZED WITH NO PATIENT ISSUE.¿. THERE WAS NO REPORT OF IMPACT/INJURY, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION 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 18310016 ↗
• MalfunctionNov 28, 2023Self-Activation or Keying; Self-Activation or Keying

  A SALES REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER THAT THE DEVICE, PLP2020, PLUMEPEN ELITE SURGICAL SMOKE EVAC PENCIL, 10FT TUBING, WAS BEING USED ON (B)(6) 2023 WNEN THE ¿CAUTERY PENCIL WAS SOMEHOW ACTIVATING THE CUT WITHOUT DEPRESSING THE BUTTON DURING DR'S CASE. THE SURGICAL TECH, WAS ABLE TO HEAR IT BEING ACTIVATED AND NOTICED THAT IT NO ONE WAS TOUCHING IT. IT WAS LUCKILY IN THE HOLSTER AND IMMEDIATELY REMOVED. THE SURGICAL TECH SAID THAT EVEN AFTER SHE REMOVED THE PENCIL FROM THE HOLSTER, THE CUT WAS STILL ACTIVATING DESPITE NOTHING TOUCHING THE SWITCH. THE FOOT PEDAL WAS NOT IN USE AND NOTHING WAS DEPRESSING THE PEDALS. NO HARM WAS DONE TO THE PATIENT OR STAFF¿. THE PROCEDURE WAS COMPLETED WITH AN ALTERNATE SAME DEVICE. FURTHER ASSESSMENT HAS BEEN SOUGHT BUT A RESPONSE HAS NOT BEEN RECEIVED. TWO LOT NUMBERS HAVE BEEN PROVIDED IN CONNECTION WITH THIS COMPLAINT; IT IS UNKNOWN WHICH LOT NUMBER REFERS TO THE DEVICE AT ISSUE. 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 18216459 ↗
• MalfunctionNov 28, 2023Self-Activation or Keying; Self-Activation or Keying

  A SALES REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER THAT THE DEVICE, PLP2020, PLUMEPEN ELITE SURGICAL SMOKE EVAC PENCIL, 10FT TUBING, WAS BEING USED ON (B)(6) 2023 WNEN THE ¿CAUTERY PENCIL WAS SOMEHOW ACTIVATING THE CUT WITHOUT DEPRESSING THE BUTTON DURING DR'S CASE. THE SURGICAL TECH, WAS ABLE TO HEAR IT BEING ACTIVATED AND NOTICED THAT IT NO ONE WAS TOUCHING IT. IT WAS LUCKILY IN THE HOLSTER AND IMMEDIATELY REMOVED. THE SURGICAL TECH SAID THAT EVEN AFTER SHE REMOVED THE PENCIL FROM THE HOLSTER, THE CUT WAS STILL ACTIVATING DESPITE NOTHING TOUCHING THE SWITCH. THE FOOT PEDAL WAS NOT IN USE AND NOTHING WAS DEPRESSING THE PEDALS. NO HARM WAS DONE TO THE PATIENT OR STAFF¿. THE PROCEDURE WAS COMPLETED WITHOUT ISSUE, WITH AN ALTERNATE SAME DEVICE. TWO LOT NUMBERS HAVE BEEN PROVIDED IN CONNECTION WITH THIS COMPLAINT; IT IS UNKNOWN WHICH LOT NUMBER REFERS TO THE DEVICE AT ISSUE. 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 18216454 ↗