SYSTEM 2450 60-2450-120Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 20653405061523), received between Jun 13, 2019 and Aug 13, 2026 — classified as 2 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Unintended Electrical Shock” (3 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 18, 2026.

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 13, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Electric Shock

  MAUDE report 50236293 ↗
• InjuryJun 5, 2025Overheating of Device; Overheating of Device

  A CUSTOMER REPORTED THAT THE DEVICE, 60-2450-120, SYSTEM 2450 120 VAC 50/60 HZ ELECTROSURIGCAL UNIT, WAS USED IN A BREAST LUMPECTOMY; WITH SENTINEL NODE DISSECTION AND LYMPHATIC MAPPING PROCEDURE ON (B)(6) 2025, AND ¿PATIENT RECEIVED TWO DIME SIZED AREAS OF A FLAT WHITE COLORED AREA THAT ALMOST RESEMBLED A BLISTER BUT NO FLUID UNDER IT FROM CONMED 2450 ESU & ELCTROSRGICAL PENCIL¿. THE PROCEDURE WAS COMPLETED WITHOUT THE USE OF AN ALTERNATE DEVICE, THE ¿AREA WAS DRESSED WITH ANTIBIOTICOINTMENT AND A TELFA DRESSING¿ AND THE PATIENT¿S STATUS WAS REPORTED AS ¿GOOD¿. FURTHER ASSESSMENT FOUND A MEDLINE PENCIL WAS IN USE. THE EVENT OCCURRED "JUST AFTER INCISION WAS MADE. MD WAS CAUTERIZING AND SHE WAS USING THE SPONGE TO MOP UP BLEEDERS AND THIS IS WHEN THEY NOTICED A RAYTEC WAS BURNING. THE PHYSICIAN SAYS SHE FELT THE PENCIL WAS RUNNING 'A BIT HOT¿ THAT DAY, SO THEY TURNED THE SETTINGS DOWN A LITTLE. ON THIS PARTICULAR CASE THE SETTINGS WERE SET TO SPRAY AT 45/45. THIS WAS NOT HER NORMAL SETTING AND THE STAFF SAID THEY DID NOT SET IT TO THAT SETTING. THEY FEEL THE SPRAY BUTTON MUST HAVE BEEN PUSHED ACCIDENTALLY. MD PERFORMING THE SURGERY DOCUMENTED THAT PATIENT SUSTAINED A BURN. IN MY IN

  Patient problems: Partial thickness (Second Degree) Burn

  MAUDE report 22148618 ↗
• MalfunctionAug 22, 2024Unintended Electrical Shock; Unintended Electrical Shock

  A CUSTOMER REPORTED THAT THE 60-2450-120, SYSTEM 2450, 120V DEVICE WAS BEING USED DURING AN UNNAMED PROCEDURE ON APPROXIMATELY (B)(6) 2024, AND ¿THE DOCTOR WAS USING THE UNIT HE RECEIVED A SHOCK¿ THERE WAS NO INJURY TO THE DOCTOR. DOCTOR RECEIVED A SHOCK WHILE USING UNIT. NO MARKS LEFT FROM SHOCK AND NO PATIENT INJURY¿. THERE WAS NO DELAY TO THE PROCEDURE, AND NO REPORT OF MEDICAL OR SURGICAL INTERVENTION, OR EXTENDED HOSPITALIZATION FOR THE PATIENT OR USER. A GOOD FAITH EFFORT WAS MADE TO OBTAIN FURTHER INFORMATION FROM THE REPORTER; HOWEVER, NO FURTHER DETAILS HAVE BEEN PROVIDED TO DATE. THIS REPORT IS BEING RAISED ON THE BASIS OF MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

  Patient problems: Electric Shock

  MAUDE report 20039037 ↗
• InjurySep 13, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  THE SALES REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER THAT THE 60-2450-120, SYSTEM 2450, 120V, WAS BEING USED DURING AN UNKNOWN PROCEDURE ON (B)(6) 2023. WHEN IT WAS REPORTED, ¿DURING PROCUDURE NURSE WAS BURNED. THE NURSE PUT HAND BETWEEN GROUNDING PAD AND PATIENT PER BIO MED.¿. THERE WAS NO REPORT OF MEDICAL INTERVENTION OR HOSPITALIZATION FOR THE USER, ONLY BURNED FINGER TIPS WERE RED FOR A WHILE. THERE WAS NO REPORT OF INJURY, MEDICAL INTERVENTION, OR HOSPITALIZATION FOR THE PATIENT. FURTHER ASSESSMENT INFORMATION FROM THE REPORTER FOUND THAT THERE WAS NO MALFUNCTION WITH THE DEVICE, USER ERROR CAUSED THE INCIDENT. CONMED HAS OFFERED FURTHER EDUCATION FOR THE STAFF. NO OTHER INFORMATION WAS AVAILABLE PER THE REPORTER. THIS REPORT IS BEING RAISED DUE TO THE REPORTED INJURY FOR UNKNOWN DEGREE OF BURN TO THE USER.

  Patient problems: Burn(s)

  MAUDE report 17735395 ↗
• MalfunctionAug 22, 2019Unintended Electrical Shock; Unintended Electrical Shock

  THE CUSTOMER REPORTED THAT 60-2450-120 DEVICE WAS BEING USED FOR MOLE REMOVAL ON (B)(6) 2019 WHEN THE DOCTOR GOT A "SHOCK" FROM THE CAUTERY. THE PATIENT DENIED FEELING A SHOCK AND UPON INSPECTION HAD NO ADVERSE REACTIONS. THE DEVICE AND GROUNDING PAD WERE INSPECTED AND FOUND TO BE INTACT AND "THE GREEN LIGHT WAS SHOWING ON THE ACTUAL MACHINE (DEVICE) TO SAY IT WAS SAFE TO USE THE MACHINE (DEVICE)". THE PROCEDURE WAS COMPLETED WITH NO ADVERSE OUTCOMES. THERE WAS NO REPORT OF INJURY TO THE PATIENT OR THE USER. THIS REPORT IS BEING RAISED ON THE BASIS OF MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8921696 ↗
• MalfunctionAug 22, 2019Unintended Electrical Shock; Unintended Electrical Shock

  THE CUSTOMER REPORTED THAT 60-2450-120 DEVICE WAS BEING USED FOR THE EXCISION OF A MOLE ON APPROXIMATELY (B)(6) 2019 WHEN THE NURSE WAS HOLDING THE HAND OF THE PATIENT AND EXPERIENCED A SHOCK. THE PATIENT STATED, THEY FELT IT "A LITTLE BIT". THE NURSE STATED THAT IT WAS COMPARABLE TO THE SHOCK RECEIVED WHEN TAKING SHEETS OFF OF A BED. THERE WAS NO REPORT OF INJURY TO THE PATIENT OR THE NURSE. THERE WAS NO MEDICAL INTERVENTION OR EXTENDED HOSPITALIZATION. THIS REPORT IS BEING RAISED ON THE BASIS OF MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8921695 ↗
• MalfunctionJun 13, 2019Flare or Flash; Flare or Flash

  THE CONMED REPRESENTATIVE REPORTED ON BEHALF OF THE FACILITY THAT THE 60-2450-120, ELECTROSURGICAL UNIT'S MIDDLE PORT (2ND MONOPOLAR PORT) CAUSED FLAMES TO COME FROM THE ELECTROSURGICAL PENCIL. THERE WAS NO REPORTED USER OR PATIENT INJURY OR IMPACT. ADDITIONAL INFORMATION RECEIVED ON JUNE 11,2019 BY THE CONMED SALES REPRESENTATIVE STATED THE ESU PENCIL WAS MADE BY COVIDIEN. THE TIP OF THE PENCIL WOULD CREATE A FLAME WHEN ACTIVATED. THIS WAS FOUND DURING PRE-OP TESTING AND WAS FOUND BEFORE ANY CONTACT WITH THE PATIENT. THE SETTINGS ON THE SYSTEM 2450 WERE 30/30 CUT/COAG. THE PROCEDURE WAS COMPLETED USING ANOTHER ESU GENERATOR. THE SYSTEM 2450 WAS SENT TO THE FACILITY CLINICAL ENGINEERING DEPARTMENT AND THEY COULD REPLICATE THE SAME RESULT FROM THE SYSTEM 2450 AND PENCIL. THIS REPORT IS BEING RAISED BASED ON DEVICE MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8697676 ↗