Coblation EIC4835-01Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00817470005455), received between May 30, 2020 and Feb 27, 2026 — classified as 1 injury, 5 malfunctions.

The most frequently reported specific device problem is “Break” (3 reports).

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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 27, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN ENT PROCEDURE, IT WAS NOTICED THAT THE REFLEX ULTRA PTR COBLATOR II WAND'S SILICONE TIP HAD DETACHED AND GOT MISSING, AS IT MIGHT HAVE FALLEN INTO THE PATIENT¿S NASAL CAVITY. THE PROCEDURE WAS RESUMED WITHOUT ANY DELAY, USING AN EQUIVALENT S+N BACK UP PRODUCT. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24477347 ↗
• MalfunctionFeb 27, 2026Material Separation; Component Missing; Material Deformation; Power Problem

  IT WAS REPORTED THAT, DURING A SURGERY, IT WAS NOTICED THAT THE TIP OF THE REFLEX ULTRA SEEMED TO BE OFF (HAD NO POWER) AND THE INSULATOR OF THE TIP DIDNT COME AT ALL WHEN THE PACKAGE WAS OPENED. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING A SIMILAR SN BACK UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24472005 ↗
• MalfunctionFeb 13, 2025Break; Break

  IT WAS REPORTED THAT DURING AN ENT PROCEDURE, THE REFLEX ULTRA COBLATOR WAND CEASED WORKING WHILST WITHIN THE TURBINATE, UPON REMOVAL, TIP OF ELECTRODE WAS MISSING, METAL TIP APPEARED FRACTURED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A SURGICAL DELAY GREATER THAN 30 MINUTES AND THE PROCEDURE WAS CEASED TO THE POINT OF FAILURE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21375824 ↗
• MalfunctionAug 15, 2023Break; Break

  IT WAS REPORTED THAT DURING AN ENT SURGERY, AFTER MAKING A FEW CHANNELLING IN THE TURBINATE THE TIP OF THE REFLEX ULTRA PTR WAND RETRACTED INTO THE WAND. THERE WAS NO BROKEN PARTS IN THE PATIENT. THE PROCEDURE WAS COMPLETED WITH NON-SIGNIFICANT SURGICAL DELAY USING A SMITH AND NEPHEW BACK UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17550885 ↗
• InjuryJun 16, 2022Break; Break

  IT WAS REPORTED THAT DURING A SEPTO/FESS PROCEDURE, THE METAL END OF THE REFLEX ULTRA WAND SNAPPED OFF AND HALF THE SILVER PART OF THE COABALTOR WAS INSIDE THE PATIENT . BACK UP DEVICE WAS AVAILABLE TO COMPLETE THE SURGERY. NO SIGNIFICANT SURGICAL DELAY WAS REPORTED. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14724679 ↗
• MalfunctionMay 30, 2020No Device Output; No Device Output

  IT WAS REPORTED THAT THE WAND DID NOT WORK WHEN PLUGGED INTO THE MACHINE. THE PROBLEM WAS SOLVED WITHIN A 30 MINUTE DELAY USING A SECOND WAND WHICH DID WORK. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10103746 ↗