Coblation AC1345-01Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00817470001860), received between Nov 30, 2017 and Dec 20, 2022 — classified as 1 injury, 6 malfunctions.

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

• MalfunctionDec 20, 2022No Apparent Adverse Event; No Apparent Adverse Event

  IT WAS REPORTED THAT DURING A SHOULDER ARTHROSCOPY, THE DEVICE ELIMINATOR WAND STOPPED WORKING, AFTER 30 MINUTES THE SURGICAL TECHNICIAN GAVE ANOTHER DEVICE TO COMPLETE THE SURGERY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A SURGICAL DELAY GREATER THAN 30 MINUTES USING A BACK-UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED. THE PATIENT IS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16016847 ↗
• InjuryApr 19, 2021Failure to Deliver Energy; Communication or Transmission Problem; Failure to Deliver Energy; Communication or Transmission Problem

  IT WAS REPORTED THAT, DURING AN ARTHROSCOPY PROCEDURE, THE ELIMINATOR ICW WAND DID NOT CUT NOR COAGULATE AND THE RADIO FREQUENCY DID NOT WORK BUT IT EMITTED SOUND AS IF IT WERE WORKING CORRECTLY. THE PROCEDURE WAS COMPLETED WITH A COMPETITOR DEVICE WITH NO FURTHER COMPLICATIONS. A DELAY EQUAL TO OR LESS THAN 30 MINUTES WAS 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 11684593 ↗
• MalfunctionJan 8, 2021Protective Measures Problem; Protective Measures Problem

  IT WAS REPORTED THAT DURING A ROTATOR CUFF REPAIR THE WAND SHOWED AN E4 ERROR CODE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT SIGNIFICANT 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 11141936 ↗
• MalfunctionMar 11, 2020Activation Problem; Activation Problem

  IT WAS REPORTED THAT, DURING A PROCEDURE, THE ELIMINATOR ICW WAS NOT ABLATING OR COAGULATING. THE SETTINGS WERE SHOWING IN THE CONTROLLER. THE PEDAL WAS NOT ACTIVATING THE WAND EITHER. AFTER DISCONNECTING AND RECONNECTING THE PEDAL, THE WAND STILL DID NOT WORK. THE CONTROLLER WAS TURNED OFF AND ON AGAIN AND THE WAND STILL DID NOT WORK. THE DOCTOR COMPLETED THE PROCEDURE WITH AN ELECTRO-SCALPEL. NO SIGNIFICANT DELAY OR 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 Known Impact Or Consequence To Patient

  MAUDE report 9822033 ↗
• MalfunctionJan 7, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT DURING SURGERY, THE WAND PRESENTED A CUTTING/COAGULATION FAILURE WITHOUT GIVING ANY WARNING SIGNAL. NO SIGNIFICANT DELAY OR PATIENT INJURIES WERE REPORTED. THE PROCEDURE WAS COMPLETED WITH THE ELECTROBISTURI OF THE INSTITUTION. 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 9562057 ↗
• MalfunctionSep 26, 2018Break

  IT WAS REPORTED THAT ANTERIOR AND POSTERIOR SITES WERE MADE FOR LENS PLACEMENT AND INSTRUMENTATION, FIRST, FOR INTRAARTICULAR VISION; SYNOVECTOMY WAS PERFORMED WITH SHAVER AND BICEPS TENOTOMY WITH BASKET CLAMP. A PARTIAL REMODELING WAS PERFORMED, AND CAUTERIZATION OF VESSELS WITH THE ELIMINATOR 90° SYSTEM (RADIOFREQUENCY) WAS PERFORMED, BUT THIS WAS BROKEN IN THE HANDLE (DISTAL PART). IT WAS NECESSARY TO CHANGE THE DEVICE FOR ANOTHER UNIT. THE BROKEN DEVICES WAS NOT FORCED OR INTRODUCED THROUGH THE SITE OR FOR THE COAGULATION OF VESSELS. A BACKUP DEVICE WAS AVAILABLE TO COMPLETE THE PROCEDURE WITH NO DELAY OR PATIENT INJURIES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7910810 ↗
• MalfunctionNov 30, 2017Device Inoperable

  IT WAS REPORTED THAT WHEN THE PEDAL WAS OPERATED TO START BEING USED, IT DID NOT WORK. WE COMPLETED THE PROCEDURE WITH ANOTHER DEVICE FROM THE OTHER COMPANY. NO PATIENT INJURIES WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7073525 ↗

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