NA AC-SI-IIIRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 05415067028945), received between Sep 4, 2020 and Sep 4, 2020 — classified as 1 injury.

The most frequently reported specific device problem is “Output 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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjurySep 4, 2020Output Problem; Output Problem

  RELATED MANUFACTURING REF: (B)(4). DURING A SIMPLICITY RF PROCEDURE WITH THE PATIENT ON THE TABLE AND PREPPED, AN ERROR MESSAGE WAS NOTED ON PORTS ONE AND TWO WHILE CONNECTED TO THE GENERATOR. AN ATTEMPT TO SWITCH PORT 1 AND 2 INTO PORT 3 WERE UNSUCCESSFUL AS THE ERRORS REMAINED AND THE PROCEDURE WAS CANCELLED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10493642 ↗