Coblation AC1340-01Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00817470001839), received between May 4, 2018 and Jul 19, 2022 — classified as 4 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Break” (2 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 19, 2022Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY PROCEDURE, THE HANDLE OF THE 90 ICW WAND OVERHEATED. THE PROCEDURE WAS COMPLETED WITHOUT SURGICAL DELAY USING AN UNKNOWN DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15058761 ↗
• MalfunctionFeb 22, 2022Break; Break

  IT WAS REPORTED THAT ON A POST-MARKET CLINICAL FOLLOW UP ACTIVITY REVIEW "PMCF JOINT FOR WANDS", THE METAL TIP OF THE 3.5MM 90 DEGREE ICW WAND DETACHED. IT IS UNKNOWN HOW THE PROCEDURE WAS COMPLETED. THE INFORMATION PROVIDED IS ANONYMIZED; THEREFORE, ADDITIONAL INFORMATION IS NOT KNOWN AND IT IS NOT POSSIBLE TO COLLECT IT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13580862 ↗
• InjuryFeb 22, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON A POST-MARKET CLINICAL FOLLOW UP ACTIVITY REVIEW "PMCF FOR JOINT WANDS", 1 PATIENT HAD A REVISION SURGERY 4 MONTHS AFTER A KNEE PROCEDURE PROCEDURE USING A 3.5MM 90 DEGREE ICW WAND. THE REVISION SURGERY WAS DUE TO A FREQUENTLY RELAPSE AND WAS PERFORMED USING VASCULAR DISSECTION FORCEPS. PATIENT OUTCOME IS UNKNOWN. THE INFORMATION PROVIDED IS ANONYMIZED; THEREFORE, ADDITIONAL INFORMATION IS NOT KNOWN AND IT IS NOT POSSIBLE TO COLLECT IT.

  Patient problems: Insufficient Information

  MAUDE report 13580704 ↗
• InjuryFeb 22, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON A POST-MARKET CLINICAL FOLLOW UP ACTIVITY (PMCF) REVIEW PMCF FOR JOINT WANDS, 1 PATIENT HAD A CHRONDRAL LESION ADJACENT TO THE CARTILAGE DURING A KNEE PROCEDURE USING A 3.5MM 90 DEGREE ICW WAND. PATIENT OUTCOME IS UNKNOWN. THE INFORMATION PROVIDED IS ANONYMIZED; THEREFORE, ADDITIONAL INFORMATION IS NOT KNOWN AND IT IS NOT POSSIBLE TO COLLECT IT.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 13580255 ↗
• InjuryFeb 22, 2022Break; Break

  IT WAS REPORTED THAT ON A POST-MARKET CLINICAL FOLLOW UP ACTIVITY (PMCF) REVIEW PMCF FOR JOINT WANDS, 1 PATIENT HAD A BURN IN THE JOINT COVER DUE TO MANEUVER DIFFICULTIES DURING A HIP PROCEDURE USING A 3.5MM 90 DEGREE ICW WAND. ADDITIONALLY, THE METAL TIP OF THE WAND DISLODGED INTO THE PATIENT'S CAVITY. PATIENT OUTCOME IS UNKNOWN. THE INFORMATION PROVIDED IS ANONYMIZED; THEREFORE, ADDITIONAL INFORMATION IS NOT KNOWN AND IT IS NOT POSSIBLE TO COLLECT IT.

  Patient problems: Burn(s)

  MAUDE report 13580141 ↗
• MalfunctionAug 25, 2020Failure to Deliver Energy; Failure to Deliver Energy

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY THE 3.5MM 90 DEGREES ICW WAND STOPPED WORKING 10 MINUTES AFTER STARTING TO USE, THE WAND BECAME UNABLE TO ACTIVATE AND WAS NOT GENERATING PLASMA. ALARM AND ERROR MESSAGE DID NOT APPEAR. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT DELAY USING A S&N 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 Known Impact Or Consequence To Patient

  MAUDE report 10452058 ↗
• MalfunctionAug 12, 2019Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT DURING SURGERY, THE DEVICE OVERHEATS. NO DELAY OR PATIENT INJURIES WERE REPORTED. A BACK UP WAS AVAILABLE TO COMPLETE THE PROCEDURE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8883760 ↗
• InjurySep 4, 2018Temperature Problem

  IT WAS REPORTED THAT DURING A SHOULDER ARTHROSCOPY SURGERY, TIP WAS USED; AT THE MOMENT OF COAGULATION, SOLUTION WITH THIS WAS IRRIGATED, BECOMES HOT AND NOTICES BURN ON THE PATIENT SKIN, THIS WAS SEEN IN THE SAME DIRECTION IN WHICH THE SOLUTION COMES OUT. PROCEDURE WAS COMPLETED WITH THE SAME RADIOFREQUENCY; BUT PARAMETERS OF COAGULATION AND CUTTING WERE CHANGED.

  Patient problems: Burn, Thermal

  MAUDE report 7843115 ↗
• MalfunctionMay 4, 2018Material Discolored; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT A NEW WAND WAS OPENED AND PASSED TO THE SURGICAL TABLE; IT WAS CONNECTED TO THE QUANTUM CONSOLE, THEN, WE STARTED TO USE IT IN ORDER TO MAKE COAGULATION IN THE LATERAL MENISCUS OF THE LEFT KNEE PATIENT; AT THE MOMENT OF ACTIVATING THE WAND WITH THE PEDAL, IT BURN THE CARTILAGE OF THE PATIENT. DOCTOR ASKED TO LOWER THE COAGULATION LEVEL THAT IS PREDETERMINED IN THE CONSOLE, BUT AT THIS MOMENT, WE NOTICED THAT THE RF WAND LOOKED BROWN AND IT WAS RELEASING PARTICLES INSIDE THE PATIENT'S JOINT. NO DELAY OR PATIENT INJURIES WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7489094 ↗

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