SYSTEM 5000 60-8005-001Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 20653405040191), received between May 13, 2019 and Aug 27, 2025 — classified as 3 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Arcing” (1 report).

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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryAug 27, 2025Energy Output Problem; Energy Output Problem

  THE SALES REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER THAT THE 60-8018-SYS, FULL SYSTEM 100 - 230 VAC 50/60 HZ ELECTROSURGICAL UNIT (SERIAL NUMBER (B)(6)) DEVICE WAS BEING USED DURING LLETZ PROCEDURE ON (B)(6) 2025 WHEN IT WAS REPORTED ¿SYSTEM 5000 CUT WORKED HOWEVER WHEN USING COAG DID NOT EFFECTIVELY STOP BLEEDING IN LLETZ PROCEDURE. BOTH SYSTEMS DID NOT WORK PATIENT RE-ENTERED HOSPITAL 24 HOURS LATER VIA A&E DUE TO EXCESSIVE BLEEDING.¿ FURTHER ASSESSMENT QUESTIONING HAS BEEN ATTEMPTED BUT TO DATE NO FURTHER INFORMATION IS AVAILABLE. THE PROCEDURE WAS COMPLETED WITH THE USE OF AN ALTERNATE CHEMICAL COAGULATION DEVICE AND A 15-MINUTE DELAY. THIS REPORT IS BEING RAISED ON THE REPORTED INJURY DUE TO THE PATIENT EXPERIENCING EXCESSIVE BLEEDING.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 22904374 ↗
• InjuryApr 4, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER REPORTED THAT THE DEVICE, 60-8018-SYS, FULL SYSTEM 100 - 230 VAC 50/60 HZ ELECTROSURGICAL UNIT, WAS BEING USED DURING AN UNKNOWN PROCEDURE ON (B)(6) 2025 WHEN IT WAS REPORTED, ¿STAFF MEMBER RECEIVED AN ELECTRIC SHOCK AS CABLE NOT HOLDING MACHINE. INJURY, SHOCK/BURN.¿. THERE WAS NO REPORT OF MEDICAL INTERVENTION OR HOSPITALIZATION FOR THE PATIENT OR THE USER. THIS CAUSED A 5-MINUTE DELAY IN THE PROCEDURE; HOWEVER, THE PROCEDURE WAS REPORTED AS BEING COMPLETED. THERE WAS NO ALLEGATION OF MALFUNCTION AGAINST THE CONMED DEVICE. FURTHER ASSESSMENT HAS BEEN REQUESTED OF THE REPORTER; HOWEVER, THE REPORTER HAS NOT RESPONDED TO DATE. THIS REPORT IS BEING RAISED DUE TO THE REPORTED INJURY OF USER RECEIVING A SHOCK AND UNKNOWN DEGREE OF BURN.

  Patient problems: Burn(s); Shock

  MAUDE report 21771912 ↗
• InjuryMar 4, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  THE CUSTOMER REPORTED THAT THE DEVICE, 60-8005-003, SYSTEM 5000, ENGLISH FRONT PANEL, INTERNATIONAL, WAS BEING USED DURING AN UNKNOWN TYPE OF PROCEDURE ON (B)(6) 2022 WHEN IT WAS REPORTED ¿ONE OF OUR SURGEONS SUSTAINED A DIATHERMY BURN WITH THIS MACHINE. AS IT WAS NOT THE FIRST TIME HE HAS REQUESTED THE MACHINE TO BE TESTED. (THE LEAD AND FORCEPS HAVE ALSO BEEN SENT TO BE TESTED). I HAVE SPOKEN WITH (FACILITY EMPLOYEE NAME) TODAY AND THEY BELIEVE THAT THE INCIDENT IS DOWN TO USER ERROR HOWEVER BECAUSE THE CONSULTANT HAS REQUESTED FOR THE UNIT TO BE TESTED THEY HAVE TO COMPLETE ALL CHECKS.¿. THE PROCEDURE WAS REPORTED AS HAVING BEEN COMPLETED AS PLANNED WITH A 15-MINUTE DELAY. THERE WAS NO REPORT OF MEDICAL INTERVENTION OR HOSPITALIZATION FOR THE USER. FURTHER ASSESSMENT QUESTIONS WERE ASKED; HOWEVER, TO DATE NO RESPONSE HAS BEEN RECEIVED FROM THE FACILITY. THIS REPORT IS BEING RAISED ON THE BASIS OF INJURY DUE TO UNKNOWN DEGREE OF BURN TO USER.

  Patient problems: Burn(s)

  MAUDE report 13665976 ↗
• MalfunctionFeb 3, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE SALES REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER THAT THE 60-8005-001, SYSTEM 5000-ENGLISH PANEL-120V, WAS BEING USED DURING AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE WHEN IT WAS REPORTED, ¿NEEDS EVALUATED SOME ARCING WHEN FORCEPS ARE TOGETHER.¿ THERE WAS NO REPORT OF INJURY, MEDICAL INTERVENTION, OR HOSPITALIZATION FOR THE PATIENT. FURTHER ASSESSMENT QUESTIONING OF THE SALES REPRESENTATIVE FOUND THAT THERE WAS NO FURTHER INFORMATION AVAILABLE. 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 13440445 ↗
• MalfunctionFeb 18, 2021Arcing; Arcing

  THIS COMPLAINT WAS CREATED FROM A REPAIR SERVICE REQUEST FOR DEVICE, 60-8005-001, WHERE THE CUSTOMER HAS REPORTED "SPARKING AT THE TIP OF THE BIPOLAR FORCEPS" IN THE STERILE FIELD DURING AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE. FURTHER ASSESSMENT INFORMATION ADVISED THAT THIS SPARKING WAS AN ARC. THE CUSTOMER STATED THAT THE DEVICE WAS CHANGED OUT FOR AN ALTERNATE DEVICE AND THE FORCEPS NO LONGER SPARKED. THE PROCEDURE WAS COMPLETED WITH NO REPORT OF INJURY, MEDICAL INTERVENTION OR HOSPITALIZATION TO 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 11344902 ↗
• MalfunctionMay 13, 2019Self-Activation or Keying; Self-Activation or Keying

  THE CUSTOMER REPORTED THAT THE 60-8005-001 DEVICE WAS CONNECTED TO A COVIDIEN PENCIL (NON-CONMED) AND THE PENCIL ACTIVATED ON ITS OWN DURING AN OPEN-HEART PROCEDURE ON AN UNKNOWN DATE. THE CUSTOMER BELIEVES THAT THE 60-8005-001 WAS THE CAUSE OF THE ACTIVATION. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO INJURY TO THE PATIENT OR THE USER. AT THE TIME OF AUTO-ACTIVATION IT IS REPORTED THAT THE PENCIL WAS IN THE DEVICE'S HOLSTER. THE SETTING OF THE 60-8005-001 ARE UNKNOWN. THERE WAS NO MEDICAL INTERVENTION OR HOSPITALIZATION REQUIRED. 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 8603139 ↗