Coblation AC2823-01Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00817470004564), received between Nov 3, 2019 and Jul 8, 2025 — classified as 4 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Break” (3 reports).

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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 8, 2025Break; Material Twisted/Bent; Break; Material Twisted/Bent

  IT WAS REPORTED THAT, DURING SURGERY, THE 2.3 MM SHORT BEVEL BLADE BROKE. IT IS UNKNOWN IF THERE WAS A BACK-UP DEVICE AVAILABLE OR IF THERE WAS A DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22447701 ↗
• MalfunctionFeb 21, 2025Peeled/Delaminated; Peeled/Delaminated

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, THE INSULATION COATING OF THE SHAFT OF THE COBLATION CABLE WAND ICW PEELED OFF AT THE START OF USE. IT IS UNKNOWN HOW THE PROCEDURE WAS COMPLETED WITH AND IF THERE WAS A SMITH AND NEPHEW BACK UP DEVICE AVAILABLE. NO SURGICAL DELAY WAS REPORTED AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21433557 ↗
• MalfunctionMay 9, 2024Material Deformation; Insufficient Device Problem Information; Material Deformation; Insufficient Device Problem Information

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, THE SHORT BEVEL WAND WAS NOT WORKING WHEN CONNECTED TO THE CONSOLE. THE PROCEDURE WAS COMPLETED WITH A S+N BACK UP DEVICE. THERE WAS A SURGICAL DELAY GREATER THAN 30 MINUTES AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19279939 ↗
• MalfunctionJan 18, 2024Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, THE SHORT BEVEL 35 DEGREE WAND TIP BROKE. IT IS IF THERE WAS A BACK-UP DEVICE AVAILABLE OR IF THERE WAS A DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18539504 ↗
• InjurySep 30, 2021Material Separation; Material Separation

  IT WAS REPORTED THAT DURING ANKLE PROCEDURE, THE 2.3MM SHORT BEVEL 35 DEGREE ICW METAL TIPS SEEMED TO HAVE FALLEN OFF DURING SURGERY; (DISINTEGRATING) LEAVING METAL DEBRIS IN THE ANKLE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT DELAY USING A S+N BACK-UP DEVICE. NO OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12558323 ↗
• InjuryFeb 19, 2021Failure to Deliver Energy; Failure to Deliver Energy

  IT WAS REPORTED THAT DURING AN ACL PROCEDURE, THE WAND FAILED TO COAGULATE AND THE TIP DID NOT WORK AT THAT TIME, ALL THE TESTS WERE CARRIED OUT BUT IT DID NOT WORK. PROCEDURE WAS COMPLETED WITH A COMPETITOR DEVICE. NO SIGNIFICANT DELAY AND 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 11347878 ↗
• MalfunctionFeb 10, 2021Break; Break

  IT WAS REPORTED THAT DURING SURGERY, THE TIP OF THE BEVEL WAND DISINTEGRATED CAUSING SMALL PARTS TO BREAK OFF IN THE PATIENT'S JOINT. THE DEVICE WORKED IN THE PRESET SETTING BUT IT WOULD NOT WORK WITH A CONTINUOUS ACTIVATION, ONLY PULSED. ALL FRAGMENTS WERE REMOVED FROM THE PATIENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT SIGNIFICANT DELAY USING A BACK-UP DEVICE. NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11306575 ↗
• InjurySep 10, 2020Connection Problem; Connection Problem

  IT WAS REPORTED THAT, DURING A WRIST ARTHROSCOPY PROCEDURE, WHEN UNCOVERING THE "2.3MM SHORT BEVEL 35° IC WAND", IT WAS EVIDENT THAT THE CONNECTION OF THE RADIOFREQUENCY TIP DID NOT MAKE CONTACT WITH THE CONSOLE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT SIGNIFICANT DELAY USING AN ALTERNATIVE S+N DEVICE, A "SHAVER 2.0". NO PATIENT INJURIES 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 Information

  MAUDE report 10516476 ↗
• InjuryJul 29, 2020Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT, DURING WAIST SURGERY, THE WAND WAS UNABLE TO PLUG INTO QUANTUM CONSOLES: IT WAS BROKEN. WHEN THE SURGEON TRIED TO PLUG IN, IT BENT THE PINS INSIDE AND DID NOT MATCH UP WITH CONSOLE. THE PROCEDURE WAS COMPLETED WITH A COMPETITOR DEVICE WITH NO SIGNIFICANT DELAY. NO OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10341866 ↗
• MalfunctionNov 18, 2019Material Separation; Material Separation

  IT WAS REPORTED THAT DURING AN ANKLE PROCEDURE, THE DEVICE TIP STARTED TO MELT. A BACKUP DEVICE WAS AVAILABLE TO COMPLETE THE PROCEDURE WITH NO DELAY AND NO PATIENT INJURIES. RESULTS OF INVESTIGATION HAVE CONCLUDED THAT THERE WERE MISSING SECTIONS OF EPOXY INSULATION AROUND THE SPACER, AND POTENTIALLY THESE PIECES MIGHT FALL INTO THE PATIENT WHICH MAKES IT A REPORTABLE EVENT. 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 9334923 ↗
• MalfunctionNov 3, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT DURING THE COURSE OF THE SURGERY THE SPECIALIST ASKED FOR THE RADIOFREQUENCY TO FINISH A REMODELING AFTER SYNOVECTOMY, THE RADIOFREQUENCY WAS PASSED TO THE TABLE WHICH WAS PROPERLY CONNECTED TO THE CONSOLE. THE HANDPIECE WAS ENTERED INTO THE JOINT TO START PERFORMING THE PROCEDURE AND WHEN IT WAS ACTIVATED WITH THE PEDAL CUT THE COAGULATION DID NOT WORK. NO MOVEMENT IN THE TISSUE WAS EVIDENT. HENCE, THE SURGEON PROCEEDED TO DISCONNECT AND RECONNECT THE TIP TO SEE IF IT WORKED, BUT IT DID NOT WORK. THE PROCEDURE WAS FINISHED USING A J&J VPR. IT IS UNKNOWN IF THERE WAS A DELAY AND NO PATIENT INJURY WAS 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 9270654 ↗

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