SurgiStat SURGII-20Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10884521041622), received between Oct 30, 2018 and Oct 30, 2018 — classified as 1 malfunction.

The most frequently reported specific device problem is “Noise, Audible” (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 18, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 30, 2018Self-Activation or Keying; Noise, Audible; Self-Activation or Keying; Noise, Audible

  ACCORDING TO THE REPORTER, PRE-OPERATIVELY, THE UNIT WAS MAKING NOISE WHEN TURNED ON. IT WAS CHECKED AND FOUND THE NOISE THEY WERE HEARING WAS THE MONOPOLAR DISCHARGING. IT WAS SHOWING AN OUTPUT IN THE ELECTRICAL SURGICAL UNIT (ESU) ANALYZER WHEN NOT ENGAGED. NO PATIENT INVOLVED.

  Patient problems: No Patient Involvement

  MAUDE report 8019147 ↗