Coblation AC4050-01Recalls & reported problems

Summary

The FDA's MAUDE database contains 28 adverse event reports that list this exact device (DI 00817470003123), received between Nov 26, 2018 and Jun 21, 2026 — classified as 8 injuries, 20 malfunctions.

The most frequently reported specific device problem is “Break” (8 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 28 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 21, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT, DURING A WRIST TFCC SURGERY, THE HEAD OF THE MICROBLATOR WAND FELL OFF. THE PROCEDURE WAS RESUMED, WITH A NON-SIGNIFICANT DELAY, USING AN EQUIVALENT SN BACK-UP. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25572667 ↗
• MalfunctionMar 5, 2026Packaging Problem

  IT WAS REPORTED THAT, BEFORE A SURGERY, UPON OPENING THE OUTER PACKAGING OF A MICROBLATOR WAND, IT WAS NOTICED THAT THE STERILE INNER PACKAGE WAS DAMAGED. THE PRODUCT WAS NOT USABLE. THE PROCEDURE WAS PERFORMED, USING AN EQUIVALENT S+N BACK-UP. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24518484 ↗
• MalfunctionFeb 27, 2026Melted; Material Separation

  IT WAS REPORTED THAT, DURING A WRIST ARTHROSCOPY, WHEN ABLATING WITH A MICROBLATOR, THE PLASTIC SHEATH SEEMED TO POP AND MELT. A SECOND MICROBLATOR WAS OPENED, BUT THE SAME HAPPENED AGAIN. IT IS UNKNOWN HOW THE PROCEDURE WAS PERFORMED OR IF THERE WAS A SURGICAL DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24471860 ↗
• MalfunctionDec 3, 2025Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT, DURING A KNEE ARTHROSCOPY, THE SURGEON OBSERVED AN UNKNOWN YELLOW FOREIGN SUBSTANCE ON THE TIP OF THE MICROBLATOR WAND THROUGH THE ARTHROSCOPE IMAGE. WHEN THE SURGEON WIPED THE TIP WITH GAUZE, HE NOTICED THAT A SMALL AMOUNT OF THE YELLOW SUBSTANCE WAS TRANSFERRED ONTO THE GAUZE. ALSO, THE SURGEON REPORTED THAT AFTER THE PROCEDURE, THE PATIENT¿S INFLAMMATION LEVEL WAS FOUND TO BE ELEVATED. THE PROCEDURE WAS RESUMED, WITH A DELAY GREATER THAN 30 MINUTES, USING AN EQUIVALENT SN BACK-UP. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Foreign Body Reaction; Tissue Irritation

  MAUDE report 23703697 ↗
• MalfunctionJul 29, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT, DURING AN ARTHROSCOPY, THE ELECTRODE TIP OF THE MICROBLATOR WAND FELL OFF INSIDE THE PATIENT. THE ELECTRODE TIP WAS RETRIEVED FROM THE PATIENT. IT IS UNKNOWN HOW THE SURGERY WAS COMPLETED. THERE WAS NO SURGICAL DELAY, AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22645136 ↗
• MalfunctionJul 21, 2025Break; Break

  IT WAS REPORTED THAT, DURING AN ENT PROCEDURE, THE FRONT END OF THE MICROBLATOR WAND WAS BROKEN. SURGERY WAS COMPLETED WITH A SMITH AND NEPHEW BACK-UP DEVICE INSTEAD. THERE WAS A SURGICAL DELAY OF LESS THAN 30 MINUTES, AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22560276 ↗
• MalfunctionMay 21, 2025Fracture; Fracture

  IT WAS REPORTED THAT, DURING AN UNKNOWN PROCEDURE, THE TIP OF THE MICROBLATOR WAND WAS BROKEN INSIDE THE PATIENT. THE TIP WAS RETRIEVED FROM THE PATIENT BUT IT IS UNKNOWN HOW. SURGERY WAS COMPLETED WITH A BACK-UP DEVICE INSTEAD. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY, AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22067074 ↗
• MalfunctionFeb 5, 2025Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, THE TIP OF THE ELECTRODE ON THE MICROABLATOR 30 WAND BROKE OFF. THE BROKEN PIECE WAS REMOVED FROM INSIDE THE PATIENT USING TWEEZERS. THE PROCEDURE WAS COMPLETED WITH A S+N BACK UP DEVICE. THERE WAS A SURGICAL DELAY OF LESS THAN 30 MINUTES AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21312907 ↗
• MalfunctionFeb 3, 2025Connection Problem; Material Deformation; Connection Problem; Material Deformation

  IT WAS REPORTED THAT, DURING AN ARTHROSCOPY PROCEDURE, THE PROBE INSIDE THE CONNECTOR OF THE MICROBLATOR 30 WAND WAS SLIGHTLY BENT AND IT WAS UNABLE TO CONNECT THE WAND TO THE QUANTUM MACHINE. SURGERY WAS COMPLETED WITH A SMITH AND NEPHEW BACK-UP DEVICE INSTEAD. THERE WAS A DELAY GREATER THAN 30 MINUTES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21292896 ↗
• MalfunctionAug 5, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT, DURING A PROCEDURE, WHEN 2 UNITS OF THE MICROBLATOR WERE CONNECTED, THE CONSOLE GAVE AN ERROR MESSAGE. SURGERY WAS COMPLETED WITH THE SAME DEVICE. THERE WAS A DELAY GREATER THAN 30 MINUTES, AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19913612 ↗
• InjuryJul 29, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A TFCC REPAIR, WHEN THE SURGEON WANTED TO CLEAN UP THE JOINT AND USED THE MICROBLATOR WAND. HE ENTERED THE WAND IN THE WRIST AND WHEN HE STEPPED ON THE FOOT PEDAL TO ACTIVATE THE WAND THE TIP FELL OFF. THE NURSING TEAM THAT THE SURGEON DID USE A NEEDLE HOLDER TO BEND THE CURVE OF THE WAND THEY HAD TO OPEN THE WRIST AND DELAYED 2 HOURS TRYING TO REMOVE THE TIP FROM THE PATIENT. THE PROCEDURE WAS COMPLETED USING A DIFFERENT SURGICAL TECHNIQUE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19850075 ↗
• InjuryOct 10, 2023Break; Break

  IT WAS REPORTED THAT DURING AN ANKLE ARTHROSCOPY, THE RADIOFREQUENCY OF THE MICROBLATOR WAS BROKEN, THE SPECIALIST TRIED TO REMOVE IT WITH A HOOK PROBE BUT IT WAS NOT POSSIBLE, THEN, THE SPECIALIST TRIED TO REMOVE THE PIECE INCREASING THE PRESSURE ON THE PUMP, BUT IT WAS NOT POSSIBLE TO KNOW ITS EXACT LOCATION AND MADE THE DECISION TO OPEN TO EXPLORE. X RAYS WERE TAKEN AND THE PIECE COULD BE SEEN EMBEDDED IN THE INSERT OF THE PROSTHESIS SO THE INSERT WAS REMOVED. THE PROCEDURE WAS COMPLETED WITH A BACK UP DEVICE WITH A THREE HOUR DELAY. THE PATIENT'S HEALTH IS STILL TO BE CONFIRMED.

  Patient problems: Foreign Body In Patient

  MAUDE report 17908087 ↗
• MalfunctionDec 19, 2022Material Separation; Material Separation

  IT WAS REPORTED THAT, DURING SET UP FOR A WRIST ARTHROSCOPY, THE TIP OF THE MICROBLATOR FELL OFF. NON-SIGNIFICANT DELAY WAS REPORTED AND THE PROCEDURE WAS FINISHED WITH A SMITH AND NEPHEW BACK UP DEVICE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16009621 ↗
• MalfunctionOct 19, 2021Failure to Read Input Signal; Failure to Read Input Signal

  IT WAS REPORTED THAT DURING A WRIST ARTHROSCOPY PROCEDURE, WHEN THE WAND WAS CONNECTED TO THE VAPORIZER IT SHOWED 0 IN CUT AND 0 IN COAGULATION, IT WAS ATTEMPTED TO MANUALLY RAISED IT AND WITH THE PEDAL BUT IT DID NOT WORK. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A DELAY GREATER THAN 30 MINUTES USING A BACK-UP DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12659250 ↗
• MalfunctionJul 22, 2021Failure to Power Up; Failure to Power Up

  IT WAS REPORTED THAT THERE WAS NO REACTION AFTER THE MICROBLATOR 30 ICW WAS CONNECTED WITH THE CONTROLLER DURING A WRIST DEBRIDEMENT, IT COULD NOT WORK. THERE WAS A SMITH AND NEPHEW BACKUP DEVICE AVAILABLE. THERE WAS A DELAY GREATER THAN 30 MIN. NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12213031 ↗
• MalfunctionJun 28, 2021Break; Break

  IT WAS REPORTED THAT, DURING AN ARTHROSCOPY, WHEN THE MICROBLATOR WAS OPENED, THE TIP OF THE MICROBLATOR WAS FOUND TO BE BENT. THE TIP BROKE, NO DAMAGE TO PATIENT SINCE THE INCIDENT TOOK PLACE OUTSIDE THE PATIENT AND BEFORE STARTING TO USE THE DEVICE. THE PROCEDURE WAS COMPLETED WITH A S+N BACK-UP DEVICE. NO SIGNIFICANT DELAY WAS REPORTED, AND NO OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12081847 ↗
• MalfunctionMay 19, 2021Break; Break

  IT WAS REPORTED THAT DURING THE SET UP BEFORE THE SURGERY WHEN THE MICROBLATOR WAND WAS OPENED, THE TIP WAS FOUND TO BE BROKEN. SMITH AND NEPHEW BACK-UP DEVICE WAS USED TO COMPLETE THE SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11850392 ↗
• InjuryFeb 19, 2021Failure to Deliver Energy; Failure to Deliver Energy

  IT WAS REPORTED THAT, DURING SURGERY, THE MICROBLATOR FAILED TO COAGULATE AND THE TIP DID NOT WORK AT THAT TIME. THE PROCEDURE WAS COMPLETED WITHOUT SIGNIFICANT DELAY USING A COMPETITOR 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 11351178 ↗
• MalfunctionFeb 10, 2021Protective Measures Problem; Protective Measures Problem

  IT WAS REPORTED THAT DURING TEST THE MICROBLATOR HAD NO REACTION, IT HAD AN E4 WAND ERROR SHORT. THERE WAS BACKUP DEVICE AVAILABLE AND NO SIGNIFICANT DELAY OR PATIENT INJURIES 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 11311633 ↗
• InjuryJan 31, 2021Break; Break

  IT WAS REPORTED THAT DURING SURGERY, THE ELECTRODE TIP OF THE MICROBLATOR WAND GOT BROKEN INSIDE THE PATIENT'S ANATOMY. ALL PIECES WERE REMOVED FROM THE PATIENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT SIGNIFICANT DELAY USING A BACK-UP DEVICE. NO 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 11256734 ↗
• InjuryDec 30, 2020Failure to Deliver Energy; Failure to Deliver Energy

  IT WAS REPORTED THAT DURING SETUP WHEN THE WAND WAS CONNECTED IT DID NOT PERFORM ANY FUNCTION. THE PROCEDURE WAS COMPLETED WITH A COMPETITOR DEVICE AND NO DELAY OR FURTHER 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 11097395 ↗
• InjurySep 3, 2020Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY SURGERY THE ELECTRODE TIP OF THE MICROBLATOR WAND BROKE OFF. ALL THE PIECES WERE REMOVED. A BACK UP DEVICE WAS AVAILABLE. THE PROCEDURE WAS COMPLETED WITHOUT DELAY. NO 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 Known Impact Or Consequence To Patient

  MAUDE report 10491771 ↗
• InjurySep 3, 2020Failure to Deliver Energy; Failure to Deliver Energy

  IT WAS REPORTED THAT DURING WRIST ARTHROSCOPY THE MICROBLATOR WORKED INTERMITTENTLY. THE WAND WAS PLUGGED IN PROPERLY AND FOOT PEDAL WAS WORKING FINE. THERE WAS A DELAY OF UNDER 30 MIN AND THE PROCEDURE WAS COMPLETED WITH A CHANGE IN SURGICAL TECHNIQUE, THE SURGEON PROCEEDED TO DO AN OPEN SURGERY. NO FURTHER 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 Known Impact Or Consequence To Patient

  MAUDE report 10491743 ↗
• InjuryJun 10, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT DURING WRIST JOINT DEBRIDEMENT, THE MICROBLATOR TIP FELL OFF WHILE IN USE. SUCTION WAS USED TO REMOVE THE DEVICE FROM THE PATIENT HOWEVER, NOT ALL PIECES WERE ABLE TO BE RETRIEVED. THE PROCEDURE WAS COMPLETED WITH DELAY OF UNDER 30 MIN AND USING A S+N BACKUP DEVICE. NO 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: Foreign Body In Patient

  MAUDE report 10139017 ↗
• MalfunctionMay 20, 2020Display or Visual Feedback Problem; Display or Visual Feedback Problem

  IT WAS REPORTED THAT, DURING AN ANTERIOR CRUCIATE LIGAMENT (ACL) ARTHROSCOPY, THE "30° MICROBLATOR WAND" SHOWED AN E4 ERROR. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT DELAY USING A BACK-UP DEVICE. 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 Known Impact Or Consequence To Patient

  MAUDE report 10074347 ↗

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