Coblation EICA7071-01Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00817470004311), received between May 3, 2018 and Jun 7, 2022 — classified as 2 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Break” (1 report).

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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 7, 2022Failure to Deliver Energy; Detachment of Device or Device Component; Failure to Deliver Energy; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A LARYNGEAL SURGERY, THE PROCISE MINI WAND HAD NO OUTPUT AFTER 15 MINUTES, THE METAL WIRES OF THE WAND FUSED. THE METAL WIRES DID NOT FALL INTO THE PATIENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A NON-SIGNIFICANT SURGICAL DELAY USING A BACK-UP DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED. AS PER INVESTIGATION, THE THERE WAS AN ELECTRODE IS COMPLETELY DETACHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14622841 ↗
• InjuryJul 1, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON LITERATURE REVIEW ¿*MANAGEMENT OF PEDIATRIC SUBGLOTTIC STENOSIS WITH BIPOLAR RADIOFREQUENCY ABLATION ¿, AFTER SURGERY WITH A PROCISE MINI LARYNGEAL COBLATOR WAND A PATIENT HAD FURTHER STENOSIS. THE COMPLICATION WAS TREATED WITH AN ADDITIONAL SURGERY. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Restenosis

  MAUDE report 12105090 ↗
• InjuryMar 8, 2021Break; Break

  IT WAS REPORTED THAT DURING A PROCEDURE, A WAND WAS USED AND AFTER A FEW MINUTES THE TIP STOPPED WORKING, IT DID NOT CUT AND WHEN IT WAS REMOVED IT NO LONGER HAD THE ELECTRODE. BACKUP DEVICE WAS AVAILABLE TO COMPLETE THE PROCEDURE. NO SIGNIFICANT DELAY AND NO PATIENT INJURIES 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 11440251 ↗
• MalfunctionMay 3, 2018Flare or Flash; Noise, Audible

  IT WAS REPORTED THAT THE DEVICE WAS MAKING THE MACHINE FLICKER, LIGHTS FLASHING, MAKING A LOUD NOISE. NO PATIENT INJURY REPORTED. DELAY GREATER THAN 30 MINUTES.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7485432 ↗