Coblation EICA4835-01Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00817470003871), received between Mar 10, 2019 and Feb 13, 2025 — classified as 1 injury, 4 malfunctions.

The most frequently reported specific device problem is “Break” (2 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 16, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 13, 2025Break; Break

  IT WAS REPORTED THAT DURING AN ENT PROCEDURE, THE REFLEX ULTRA PTR COBLATOR II WAND BLADE BROKE INSIDE THE PATIENT¿S NOSE-TURBINATE. THE SURGEON STATED THAT ATTEMPTING TO REMOVE THE BROKEN PIECE COULD CAUSE MORE HARM, SO THE PIECE WAS LEFT INSIDE THE PATIENT¿S NOSE. IT IS UNKNOWN WHETHER A BACK-UP DEVICE WAS AVAILABLE OR IF THERE WAS A SURGICAL DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 21375932 ↗
• MalfunctionDec 6, 2023Break; Break

  IT WAS REPORTED THAT DURING AN ENT, A REFLEX ULTRA WAND TIP BENT DOWN UPON WITHDRAWAL FROM THE PATIENT´S TURBINATE AND AFTERWARDS THE TIP BROKE OFF OUTSIDE OF THE SURGICAL FIELD. SURGERY CONTINUED WITHOUT ANY DELAY; HOWEVER IT IS UNKNOWN HOW WAS COMPLETED. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18279595 ↗
• MalfunctionNov 30, 2023Failure to Conduct; Premature End-of-Life Indicator; Failure to Conduct; Premature End-of-Life Indicator

  IT WAS REPORTED THAT DURING AN ENT PROCEDURE, WHEN TWO (2) REFLEX ULTRA WERE PLUGGED IN, THEY DISPLAYED "EXPIRED HANDPIECE". THE PROCEDURE WAS COMPLETED WITH A COMPETITOR DEVICE AND WITH A SURGICAL DELAY GREATER THAN 30 MINUTES. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18236644 ↗
• MalfunctionJul 17, 2020Output Problem; Output Problem

  IT WAS REPORTED THAT DURING A TURBINATE REDUCTION THE REFLEX ULTRA COBLATOR DEFAULT WAS 0 AND 0 INSTEAD 4 AND 2. THE WAND WOULD NOT ABLATE OR CREATE PLASMA. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT DELAY USING A BACK-UP DEVICE. NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10292670 ↗
• MalfunctionMar 10, 2019Output Problem

  IT WAS REPORTED THAT DURING TURBINATE REDUCTION SURGERY, WHEN THE ABLATE FOOT PENAL WAS INITIALLY DEPRESSED, THE ABLATE SETTING WENT TO ¿0¿ AND NOTHING OCCURRED. A NEW WAND WAS OPENED BUT THE SAME ISSUE OCCURRED. PROCEDURE WAS CANCELLED. NO PATIENT INJURIES WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8406503 ↗