Coblation EIC6895-01Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00817470000382), received between Feb 22, 2021 and Oct 5, 2021 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Suction Failure” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 5, 2021Material Separation; Material Separation

  IT WAS REPORTED THAT DURING SET UP FOR A TURBINOPLASTY SURGERY, WHEN THE SURGEON WAS PRIMING THE SALINE , THE WHOLE HEAD OF THE TURBINATOR COBLATOR II DROPPED OUT; IT BROKE, THE SURGEON USED AN ALTERNATIVE RF TO DO THE TURBINOPLASTY AS HE HAD ONLY ONE DEVICE WITH HIM. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO DELAY, CHANGING THE SURGICAL TECHNIQUE. NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12580167 ↗
• MalfunctionApr 8, 2021Suction Failure; Suction Failure

  IT WAS REPORTED THAT DURING THE MIDDLE OF THE ENT PROCEDURE, THE WAND LOST ALL SUCTION FUNCTION. BACKUP DEVICE WAS AVAILABLE TO COMPLETE THE PROCEDURE. A DELAY GREATER THAN 30 MINUTES WAS REPORTED. HOWEVER, NO PATIENT 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 11633679 ↗
• MalfunctionFeb 22, 2021Suction Failure; Suction Failure

  IT WAS REPORTED THAT, DURING AN INFERIOR TURBINOPLASTY, THE TURBINATOR COBLATOR II WAS CLOGGED DESPITE FLUSHING IT WITH SALINE. WHEN THE SURGEON DEPRESSED ON THE ABLATE PEDAL NO ORANGE SPARK WAS FORMED WHEN THE WAND WAS PLACED IN SALINE. THE PROCEDURE WAS COMPLETED WITH A DELAY GREATER THAN 30 MINUTES, 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 11362881 ↗