SYSTEM 5000 60-8005-002Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 20653405040207), received between May 9, 2024 and May 15, 2024 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Activation Problem” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 15, 2024Noise, Audible; Activation Problem; Noise, Audible; Activation Problem

  A SALES REPRESENTATIVE REPORTED ON BEHALF OF A CUSTOMER THAT THE 60-8005-002, SYSTEM 5000, SYMBOLS FRONT PANEL, INTERNATIONAL DEVICE WAS BEING USED DURING AN UNNAMED PROCEDURE ON (B)(6) 2024 AND, ¿AFTER 10-15 MIN. OF USE, CONMED 130317 HANDPIECE CONNECTED AND MEGADYNE MEGASOFT PLATE CONNECTED, THE ELECTROSURGICAL UNIT BEGINS TO EMIT A LOUD. THE CUT AND THE CLOT ACTIVATE ON THEIR OWN. TURN THE MACHINE OFF AND ON AGAIN SEVERAL TIMES: THE DEFECT IS REPEATED EVEN WHEN CHANGING ACCESSORIES.¿. FOLLOW-UP ASSESSMENT FOUND ¿THE REUSABLE PENCIL USED IS A NORMAL CONMED ACCESSORY AND THAT THE ONLY CONNECTED ACCESSORY DIFFERENT FROM THE USUAL WAS THE LARGE DISPERSIVE ELECTRODE. THE 130317 AND THE MEGADYNE MEGASOFT PLATE DEVICES DID NOT CAUSE ANY PROBLEMS AND WORKED CORRECTLY.¿. THERE WAS NO REPORT OF DELAY TO THE PROCEDURE OR 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. THE 130317, PENCIL,BUTTON,REUSABLE,10/CASE WILL BE LISTED AS A CONCOMITANT DEVICE. THERE ARE NO ALLEGATIONS AGAINST IT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19322545 ↗
• MalfunctionMay 9, 2024Self-Activation or Keying; Self-Activation or Keying

  THE SALES REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER, THAT THE 60-8005-002, SYSTEM 5000, SYMBOLS FRONT PANEL, INTERNATIONAL WAS BEING USED ON (B)(6) 2024 DURING A SKIN TISSUE REMOVAL PROCEDURE WHEN IT WAS REPORTED ¿AFTER 10 MINUTES OF USE, WITH THE HANDPIECES AND DISPERSIVE ELECTRODES CONNECTED A LOUD HOLES STARTS. CUT AND COAG START ON THEIR OWN. ERROR 112 APPEARS ON THE DISPLAY, TURNED IT ON AND OFF AND CHANGED ACCESSORIES, BUT IT KEPT REPEATING SEVERAL TIMES.¿. FURTHER ASSESSMENT QUESTIONING FOUND THAT THE PROCEDURE WAS COMPLETED "BY REPLACING THE NEW CONMED GENERATOR WITH AN OLD VALLEYLAB GENERATOR STILL SUPPLIED TO THE O.R.". 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 19277756 ↗