Coblation AC5531-01Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00817470003512), received between Mar 22, 2019 and Apr 28, 2023 — classified as 3 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Material Separation” (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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 28, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, A PURPLE SUBSTANCE DROPPED OFF FROM THE PARAGON WAND WHILE THE SURGEON WAS PRESSING ON EITHER COAGULATE OR ABLATE PEDAL. THE SUBSTANCE WAS REMOVED FROM THE PATIENT BY SUCTION FROM THE SHAVER. THE PROCEDURE WAS COMPLETED WITHOUT DELAY USING THE SAME FAULTY DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16838886 ↗
• InjuryMay 30, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON LITERATURE REVIEW "FOUR-YEAR RESULTS FROM A RANDOMIZED CONTROLLED STUDY OF KNEE CHONDROPLASTY WITH CONCOMITANT MEDIAL MENISCECTOMY: MECHANICAL DEBRIDEMENT VERSUS RADIOFREQUENCY CHONDROPLASTY", 4 PATIENTS HAD PERSISTENT KNEE PROBLEMS AFTER A MENISECTOMY USING A PARAGON WAND, THEREFORE, A REVISION SURGERY WAS REQUIRED. PATIENTS OUTCOME IS UNKNOWN. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 14541362 ↗
• InjuryMay 17, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT 7 DAYS AFTER A KNEE ARTHROSCOPY WITH A COBLATION PROBE PARAGON T2 AND A COBLATION PROBE SUPERMULTIVAC 50, A PATIENT RETURNED TO THE OPERATING ROOM TO CLEAN BLISTERS ON THE SKIN. THE PROBES WERE USED IN THE MEDIAL PORTAL OF THE RIGHT KNEE AND THE BLISTERS WERE FORMED IN THE LATERAL PORTAL, ALL THE WAY DOWN THE LEG. A SMITH & NEPHEW SKIN CARE DRESSING FOR WOUND CARE WAS USED.

  Patient problems: Blister; Skin Inflammation/ Irritation

  MAUDE report 14418520 ↗
• MalfunctionApr 20, 2021Power Problem; Power Problem

  IT WAS REPORTED THAT, THE WAND DID NOT WORK AFTER CONNECTING IT TO QUANTUM MACHINE. THE CONTROLLER DID INDICATE THAT THE WAND WAS ACTIVATED WITH AN AUDIBLE TONE. IT IS UNKNOWN IF THE EVENT OCCURRED DURING SURGERY OR IF THERE WAS A DELAY. IT IS UNKNOWN WHAT PROCEDURE WAS BEING PERFORMED OR IF THERE WAS A BACKUP DEVICE AVAILABLE. NO PATIENT INJURY 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 11697795 ↗
• InjuryMar 11, 2021Material Separation; Material Separation

  IT WAS REPORTED THAT, DURING A CHONDROPLASTY, USING THE PARAGON T2 ICW THE ELECTRODE CAME LOOSE. THE ELECTRODE WAS REMOVED WITH A GRASPER. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT 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 11465380 ↗
• MalfunctionOct 30, 2020Delivered as Unsterile Product; Contamination /Decontamination Problem; Delivered as Unsterile Product; Contamination /Decontamination Problem

  IT WAS REPORTED THAT DURING SETUP FOR A KNEE ARTHROSCOPY, WAND SEALED PACKAGE HAD FOREIGN BODIES, TWO BLACK SPOTS. THERE WAS BACKUP DEVICE AVAILABLE AND NO DELAY OR FURTHER COMPLICATIONS REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Patient Involvement

  MAUDE report 10760216 ↗
• MalfunctionJan 17, 2020Flaked; Flaked

  IT WAS REPORTED THAT, DURING THE CARTILAGE DEBRIDEMENT IN A KNEE ARTHROSCOPY PROCEDURE, PARTS OF THE PARAGON T2 COBLATION WAND CHIPPED OFF AND GOT STUCK ON THE TISSUE/CARTILAGE THAT WAS BEING DEBRIDED. THE ISSUE WAS COMPLETED WITH THE USE OF DYONIC SHAVER TO CLEAN THE DEBRIS OFF OF THE CARTILAGE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH MINIMAL DELAY RELATED TO THE ISSUE. THE PATIENT WAS NOT HARMED. 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 9601106 ↗
• MalfunctionSep 16, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT DURING KNEE PROCEDURE, THE PARAGON T2 WAND WAS CONNECTED WITH THE QUANTUM 2, BUT THE MACHINE STILL SHOWED THE INDICATION "CONNECT WAND", EVEN WHEN THE WAND WAS CONNECTED WITH THE MACHINE. THE PROCEDURE WAS COMPLETED WITH SIGNIFICANT DELAY USING A COMPETITOR BACK-UP DEVICE. NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9069996 ↗
• MalfunctionJul 2, 2019Material Separation; Material Separation

  IT WAS REPORTED THAT DURING A KNEE ARTHROSCOPY PROCEDURE, THE SURGEON WAS CLEANING THE PATIENT CARTILAGE AND AFTER SEVERAL MINUTES THE ELECTRODE TIP COMPLETELY DETACHED FROM THE DEVICE AND FELL INTO THE PATIENT WOUND. X-RAYS WERE PERFORMED TO LOCATE THE ELECTRODE, BUT DESPITE THE ATTEMPTS FOR RETRIEVAL, IT COULD NOT BE REMOVED FROM THE PATIENT. THIS CAUSED A DELAY IN THE PROCEDURE OF MORE THAN TWO HOURS AND THE INITIAL KNEE REPAIR WAS NOT COMPLETED.

  Patient problems: Foreign Body In Patient

  MAUDE report 8754309 ↗
• MalfunctionMar 22, 2019Poor Quality Image

  IT WAS REPORTED THAT DURING A WRIST SCOPE, THE SURGEON WAS USING THE RF WAND BUT THERE WERE BLUISH CHIPS SEEN, THESE MATERIAL WERE REMOVED FROM PATIENT. THE PROCEDURE WAS COMPLETED WITH THE SAME DEVICE. NO DELAY OR PATIENT INJURY REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8446418 ↗

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