Coblation AC1830-01Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00817470001907), received between Mar 11, 2021 and May 30, 2022 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (1 report).

1 other recall cover devices cleared under the same FDA submission (K033584); they may or may not involve this specific model.

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.

• InjuryMay 30, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON THE LITERATURE REVIEW "THERMAL CAPSULORRHAPHY FOR ISOLATED POSTERIOR INSTABILITY OF THE GLENOHUMERAL JOINT WITHOUT LABRAL DETACHMENT"; AFTER A THERMAL CAPSULORRHAPHY PROCEDURE WHERE A CAPSURE COBLATION WAND WAS USED, 1 PATIENT HAD A BILATERAL POSTERIOR INSTABILITY. IT WAS TREATED WITH BILATERAL THERMAL CAPSULORRHAPHY WITH A MONTH BETWEEN SHOULDERS AND WAS NOT IMMOBILIZED AFTER SURGERY. 2 MONTHS AFTER THIS, THE PATIENT EXPERIENCED RECURRENT INSTABILITY, THEN HE NOTED A MARKED DIMINUTION IN SUBLUXATION EPISODES AND RETURNED TO SPORTS ACTIVITY. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Joint Dislocation

  MAUDE report 14545173 ↗
• MalfunctionFeb 10, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A WRIST ARTHROSCOPY, THE TIP OF THE WAND 'CAPSURE 30' WAS DETACHED FROM THE SHAFT UPON PULLING IT OUT OF THE PATIENT'S HAND. THE CASE WAS COMPLETED WITH A DELAY OF 5MIN USING THE ANGLE PROBE 'VULCAN MICRO TAC-S' AS BACKUP DEVICE. THERE WAS NO HARM AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13509985 ↗
• InjuryMar 11, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT HAD A BURN AFTER AN ARTHROSCOPY IN WHICH A CAPSURE 30 ICW WAND WAS USED. IT IS UNKNOWN IF THERE WAS A BACKUP DEVICE WAS AVAILABLE AND HOW THE ISSUE WAS RESOLVED. NO DELAYS 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: Burn(s)

  MAUDE report 11467371 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K033584. One submission often covers many models, so check the product and lot details in each record.

• Z-2309-2008 · Apr 9, 2008 · Terminated
  ArthroCare ArthroWand Covator with Integrated Cable Wand, Catalog number AC4340-01. The product is a medical device for human use in electrosurgical cutting and coagulation access