Coblation EICA6895-01Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00817470005240), received between Mar 21, 2018 and Dec 22, 2023 — classified as 2 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Device Inoperable” (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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryDec 22, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER A TURBINATE REDUCTION SURGERY WITH A TURBINATOR COBLATOR II, HAS RESULTED IN A DELAYED POSTOPERATIVE SECONDARY ATROPHIC RHINITIS AND AN IATROGENIC BREATHING DISORDER, FORMALLY DIAGNOSED AS "EMPTY NOSE SYNDROME" (J34.89 (ICD-10-CM)]) IN BOTH NASAL VALVES, HAVING A DIRECT CONNECTION TO COBLATION THAT RESULTED IN SEVERE DAMAGE OF INFERIOR TURBINATE. THE INFERIOR TURBINATE VOLUME HAS BEEN REDUCED BY (B)(4) BILATERALLY. NASAL BURNING, DYSPNEA, CENTRAL SLEEP APNEA (FROM MISSING TRPM8 RECEPTORS), JOLTS BEFORE SLEEP, RESTLESS LEGS AT NIGHT, PARADOXICAL NASAL OBSTRUCTION, DEPRESSION, ANXIETY, FATIGUE, OCCASIONAL EAR FULLNESS, INTERNAL VALVES COLLAPSE, DISRUPTED NASAL CYCLE, 30-40% DECREASE IN SENSE OF SMELL, DECREASE IN NASAL AIRFLOW RESISTANCE AND NASAL AIRFLOW PATTERN, NERVE DAMAGE, SEVERE INTRANASAL DRYNESS (FROM HISTOPATHOLOGICAL AND SURFACE DAMAGE TO MUCOSA), LEADING TO FREQUENT CLOGGING OF POSTERIOR NASAL PASSAGES, AND LACK OF NATURAL INTRANASAL AIR WARMING, HUMIDIFICATION AND FILTERING, AS INFERIOR TURBINATES ARE NOW SEVERELY AND IRREVERSIBLY DAMAGED. THIS INFERIOR TURBINATE DAMAGE HAS RESULTED IN NASAL BREATHING BECOMING UNNATURAL, EQUAL TO MOUTH BREATHING

  Patient problems: Anxiety; Apnea; Depression; Dyspnea; Fatigue; Fibrosis; Nasal Obstruction; Sleep Dysfunction; Upper Respiratory Tract Injury

  MAUDE report 18387314 ↗
• InjuryOct 14, 2020Device Alarm System; Device Alarm System

  IT WAS REPORTED THAT, DURING AN ARTHROSCOPIC PROCEDURE, THE "TURBINATOR COBLATOR II" PRESENTED A RED ALARM. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT DELAY WITH A CHANGE IN THE SURGICAL TECHNIQUE. NO FURTHER 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 Information

  MAUDE report 10681253 ↗
• MalfunctionSep 22, 2020Failure to Deliver Energy; Failure to Deliver Energy

  IT WAS REPORTED THAT THE TURBINATOR COBLATOR II WAS NOT ABLATING; THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT DELAY USING A REFLUX ULTRA PTR DEVICE. NO 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 Information

  MAUDE report 10568886 ↗
• MalfunctionJan 3, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT DURING SURGERY, THE WAND WAS FAILING. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH UP TO 30 MINUTES OF DELAY USING A COMPETITOR 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 9548885 ↗
• MalfunctionDec 27, 2018Break; Material Integrity Problem

  IT WAS REPORTED DURING SURGERY THAT THE IV TUBING GOT SMASHED DURING PACKAGING, THEY WERE CRIMPED TOGETHER WHEN TAKEN OUT OF THE PACKAGE. THE PROCEDURE WAS COMPLETED WITH MANUAL INSTRUMENTS, THERE WAS NO BACK UP DEVICE AVAILABLE. NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8198972 ↗
• MalfunctionMar 21, 2018Device Inoperable

  IT WAS REPORTED THAT TWO DEVICES STOPPED WORKING DURING CASES ON THE SAME DAY. BOTH PROCEDURES WERE COMPLETED USING A COMPETITIVE DEVICE (BOVIE). NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED. COMPLAINT 2 OF 2. SEE RELATED (B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7358768 ↗
• MalfunctionMar 21, 2018Device Inoperable

  IT WAS REPORTED THAT TWO DEVICES STOPPED WORKING DURING CASES ON THE SAME DAY. BOTH PROCEDURES WERE COMPLETED USING A COMPETITIVE DEVICE (BOVIE). NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED. COMPLAINT 1 OF 2. SEE RELATED (B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7358767 ↗