SYSTEM 5000 60-8018-SYSRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 20653405040979), received between Jan 19, 2024 and Feb 12, 2024 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Overheating of Device” (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.

• MalfunctionFeb 12, 2024Unintended Electrical Shock; Unintended Electrical Shock

  THE CUSTOMER REPORTED THAT THE DEVICE, 60-8018-SYS, THE SYS 5000-FULL, ENG FP, INT, DURING POST-OP ON (B)(6) 2024 WAS REPORTED AS, ¿AFTER CASE WAS FINISHED AND MACHINE WAS UNPLUGGED, SCRUB NURSE TOUCHED THE PRONGS OF THE POWER CABLE AND RECEIVED MILD 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: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18683998 ↗
• InjuryJan 19, 2024Overheating of Device; Overheating of Device

  THE SALES REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER THAT 60-8018-SYS, THE SYS 5000-FULL, ENG FP, INT WAS BEING USED ON 24NOV23 AND ¿CAUTERY DEVICE WOULD NOT START CAUTERIZING FOR A LEG VEIN HARVEST. THE BUTTONS REPEATEDLY WOULD NOT FUNCTION. AFTER A TIME TRYING TO USE THE PENCIL, SUDDENLY IT STARTED DELIVERING ENERGY INTENSELY AND CAUSED A .5CM X1CM BURN TO THE PATIENT'S SHIN NEAR THE OPERATIVE SITE. SURGEON AWARE.¿. A GOOD FAITH EFFORT WAS MADE TO OBTAIN FURTHER INFORMATION FROM THE REPORTER; HOWEVER THE REPORTER HAS NOT RESPONDED TO OUR ATTEMPTS FOR INFORMATION. THIS REPORT IS BEING RAISED ON REPORTED INJURY DUE TO A BURN OF UNKNOWN DEGREE TO THE PATIENT.

  Patient problems: Burn(s)

  MAUDE report 18544162 ↗