ArC SMART ArC SMART ProbeRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00724995209087), received between Dec 16, 2022 and Dec 16, 2022 — classified as 1 death.

The most frequently reported specific device problem is “Use of Device 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.

• DeathDec 16, 2022Use of Incorrect Control/Treatment Settings; Use of Device Problem; Use of Incorrect Control/Treatment Settings; Use of Device Problem

  THE USER FACILITY REPORTED THAT DURING A COLONOSCOPY PROCEDURE WHICH INCLUDED USE OF THEIR GI4000 ELECTROSURGERY UNIT (ESU) AND ARC SMART ARGON COAGULATION PROBES FOR TREATMENT OF ARTERIOVENOUS MALFORMATIONS, THE PATIENT EXPERIENCED RESPIRATORY DISTRESS. THE PROCEDURE WAS STOPPED, AND THE PATIENT WAS INTUBATED AND TRANSFERRED TO THE ICU.

  Patient problems: Respiratory Arrest

  MAUDE report 15996877 ↗