HelixAR 60-8800-001Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 30653405005531), received between Jun 26, 2024 and Jun 26, 2024 — classified as 1 malfunction.

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.

• MalfunctionJun 26, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER REPORTED THAT THE 60-8800-001, HELIXAR ESU, DEVICE WAS BEING USED DURING A CANALICULOPLASTY PROCEDURE ON (B)(6) 2024 WHEN IT WAS REPORTED ¿THE CIRCULATOR ATTACHED A THERMOGARD +ABC PAD TO THE PATIENT, IN ANTICIPATION FOR IF THE SURGEON WANTED TO USE ANY MONOPOLAR ENERGY, DESPITE HER SETTING UP THE HELIX FOR BIPOLAR USE. DURING THIS SET UP, THE NURSE ACCIDENTALLY PLUGGED IN THE TWO BIPOLAR PLUGS INTO THE ARGON HAND PIECE OUTLETS. WHEN THE SURGEON WENT TO ACTIVATE ENERGY, THE SURGEON REMEMBERS HEARING A ¿ZAP¿ SOUND AND THAT THEY BELIEVE THIS IS RELATED TO THE SUPERFICIAL BURN ON THE PATIENT THAT APPEARED FROM THIS CASE. THE BURN IS AROUND THE PATIENT¿S ORBITAL REGION. THEY ARE WANTING TO REPORT THIS AS A PATIENT BURN DUE TO THE HELIX ALBEIT SET UP INCORRECTLY AND THE NUMEROUS USER ERRORS (I.E., ARGON TANK SLIGHTLY BEING OPEN DESPITE WANTING BIPOLAR ENERGY, GROUNDING PAD STILL APPLIED EVEN THOUGH THEY WANTED BIPOLAR ENERGY, INCORRECTLY INSERTING BIPOLAR PLUGS INTO ARGON HANDPIECE OUTLETS).¿. FURTHER ASSESSMENT FOUND THAT "REPORT FROM THE PHYSICIAN, THE BURN IS HEALING WELL." THE DEGREE OF SUPERFICIAL BURN WAS NOT REPORTED IT IS UNKNOWN AND THE HAND PIECE WAS BELIEVED TO B

  Patient problems: Superficial (First Degree) Burn

  MAUDE report 19617666 ↗