Coblation ACH4041-01Recalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 00817470003574), received between May 16, 2018 and Nov 21, 2025 — classified as 5 injuries, 14 malfunctions.

The most frequently reported specific device problem is “Break” (5 reports).

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 19 most recent of 19 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 21, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT, DURING A SEQUESTRECTOMY OF TARSAL BONE FOR OSTEOMYELITIS, THE TIP OF A TOPAZ EZ WAND CAME OFF IN THE PATIENT. THE TIP WAS DISSECTED WITH A PIECE OF TISSUE IT WAS LOGGED INTO, USING X-RAYS TO FIND THE PIECE. THE PROCEDURE WAS RESUMED, AFTER A 60-MIN SURGICAL DELAY, USING AN EQUIVALENT S+N BACK-UP. ADDITIONAL ANESTHESIA WAS REQUIRED AS CONSEQUENCE OF THE SURGICAL PROLONGATION. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23619008 ↗
• MalfunctionApr 8, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT DURING A PROCEDURE, WHEN THE TOPAZ WAND WAS CONNECTED TO THE QUANTUM CONSOLE, AN ERROR WAS SHOWN. THERE WAS A DELAY GREATER THAN 30 MINUTES AND A COMPETITOR DEVICE WAS USED TO FINISH THE PROCEDURE. NO PATIENT INVOLVEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19058811 ↗
• InjuryApr 24, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON CLINICAL REVIEW PMCF FOR TURBOVAC 90 XL ICW, MULTIVAC 50 XL ICW & TOPAZ EZ IFS, DURING A PROCEDURE TO TREAT A RANGE MOVEMENT ISSUE OF 1 PATIENT, WHILE USING A TOPAZ WAND THE PATIENT SUFFERED A RECOVERABLE CUTANEOUS AND SUBCUTANEOUS LESION. A CAMERA HEAD THAT WAS USED HAD A UNSUITABLE FIBRE IN SPITE OF INDIRECT CONNECTION. ADDITIONALLY A FOOT PEDAL, LENS INTEGRATED SYSTEM AND AN INTELLION LINK WEREWOLF WERE USED. PATIENT OUTCOME IS UNKNOWN. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 16797277 ↗
• MalfunctionMar 14, 2023Break; Break

  IT WAS REPORTED THAT IN THE MIDDLE OF SET-UP, A TOPAZ WAND´S BLACK COVER ALONG WITH THE SHARP TIP BROKE OFF. NO DELAY WAS REPORTED NOR PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16542007 ↗
• InjuryMay 24, 2022Break; Break

  IT WAS REPORTED THAT DURING A PROCEDURE, AFTER PREPARATION, THE TIP OF THE TOPAZ COBLATION WAND WAS BROKEN. THE PROCEDURE WAS COMPLETED WITH A NON-SIGNIFICANT DELAY USING A SMITH AND NEPHEW BACK-UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14484049 ↗
• InjuryFeb 7, 2022Break; Break

  IT WAS REPORTED THAT DURING A FASCIECTOMY PROCEDURE, THE TIP OF THE TOPAZ WAND BROKE OFF INSIDE THE PATIENT. NO BROKEN PIECE INSIDE THE PATIENT WAS LOCATED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT DELAY USING A BACK-UP DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13471936 ↗
• InjuryDec 3, 2021Protective Measures Problem; Protective Measures Problem

  IT WAS REPORTED THAT DURING AN ENT PROCEDURE, THE TOPAZ WAND DISPLAYED AN E7 ERROR MESSAGE ON THE SCREEN. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A 31-60MIN DELAY USING A BACK-UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12927191 ↗
• MalfunctionOct 18, 2021Break; Break

  IT WAS REPORTED THAT DURING USE, OUTSIDE THE PATIENT, THE TOPAZ EZ IFS WHEN THE DOCTOR STARTED THE PROCEDURE THE TIP WAS LOOSE, AFTER A FEW ATTEMPTS IT COMPLETELY BROKE OFF. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO SURGICAL DELAY USING A BACK-UP DEVICE. NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12647766 ↗
• MalfunctionAug 9, 2021Protective Measures Problem; Protective Measures Problem

  IT WAS REPORTED THAT DURING A RELEASE OF PLANTAR FASCIA PROCEDURE AN E7 ERROR MESSAGE OCCURRED WHEN A NEW WAND WAS OPENED AND CONNECTED TO THE CONTROLLER. BACKUP DEVICE WAS AVAILABLE TO COMPLETE THE PROCEDURE. A DELAY GREATER THAN 30 MINUTES WAS REPORTED WITH NO PATIENT INJURIES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12298129 ↗
• MalfunctionJan 7, 2021Energy Output Problem; Energy Output Problem

  IT WAS REPORTED THAT DURING THE CASE, THE CONSOLE WAS NOT FUNCTIONING (NOT ABLATING) WHILE ABLATE WAS PRESSED AND TOPAZ WANDS WERE PLUGGED IN. THE WANDS WERE REGISTERING ON THE DISPLAY, JUST THE ABLATE FUNCTION WAS NOT WORKING OR LIGHTING UP ON THE DISPLAY. THE PATIENT WAS ON THE TABLE, AND THERE WAS A 30-45 MIN DELAY CAUSED AND NEITHER ONE OF THE TOPAZ WANDS FUNCTIONED PROPERLY TO FINISH THE CASE. 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 11134773 ↗
• MalfunctionJan 7, 2021Energy Output Problem; Energy Output Problem

  IT WAS REPORTED THAT DURING THE CASE, THE CONSOLE WAS NOT FUNCTIONING (NOT ABLATING) WHILE ABLATE WAS PRESSED AND TOPAZ WANDS WERE PLUGGED IN. THE WANDS WERE REGISTERING ON THE DISPLAY, JUST THE ABLATE FUNCTION WAS NOT WORKING OR LIGHTING UP ON THE DISPLAY. THE PATIENT WAS ON THE TABLE, AND THERE WAS A 30-45 MIN DELAY CAUSED AND NEITHER ONE OF THE TOPAZ WANDS FUNCTIONED PROPERLY TO FINISH THE CASE. 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 11134702 ↗
• MalfunctionOct 29, 2020Protective Measures Problem; Protective Measures Problem

  IT WAS REPORTED THAT DURING THE SURGERY, WHEN THE WAND WAS PLUGGED INTO THE QUANTUM CONTROLLER, IMMEDIATELY ALARMED STATING "WAND ERROR". THE WAND COULD NOT BE USED AND A DIFFERENT TECHNIQUE WAS USED IN ORDER TO COMPLETE THE SURGERY. NO OTHER COMPLICATIONS OR SIGNIFICANT DELAY 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 10754129 ↗
• MalfunctionAug 16, 2020Image Display Error/Artifact; Image Display Error/Artifact

  IT WAS REPORTED THAT THE TOPAZ WAND WAS CONNECTED WITH CONTROLLER AND E7 AND E8 ALARM OCCURRED. THE MALFUNCTION WAS FOUND DURING SET UP OF ACHILLES TENDON SURGERY. NO 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 Patient Involvement

  MAUDE report 10411943 ↗
• InjuryJun 13, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT DURING AN ELBOW PROCEDURE THE WAND'S TIP BROKE INSIDE THE PATIENT. THE SURGEON TRIED TO USE FLUID TO WASH OUT THE JOINT AND USED X RAY TO LOCATE THE TIP BUT WAS NOT ABLE TO SUCCESSFULLY LOCATE AND REMOVE THE TIP; HENCE, IT STAYED IN THE PATIENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH SIGNIFICANT DELAY USING THE SAME DEVICE. NO OTHER COMPLICATIONS WERE REPORTED. THE PATIENT OUTCOME IS UNKNOWN. 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 10151370 ↗
• MalfunctionJun 9, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT THE TIP OF THE WAND FELL OFF. INCIDENT OCCURRED BEFORE THE PROCEDURE; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT. 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 10136072 ↗
• MalfunctionSep 26, 2019Material Separation; Material Separation

  IT WAS REPORTED THAT THE DURING A MICROABLATION PLANTAR FASCIA PROCEDURE, A PIECE OF THE TIP OF THE WAND BROKE OFF. JUST A PIECE OF THE SMALL TIP WASN'T ABLE TO BE RETRIEVED FROM THE FOOT. A BACKUP DEVICE WAS AVAILABLE TO COMPLETE THE PROCEDURE WITH NO SIGNIFICANT DELAY OR PATIENT INJURIES.

  Patient problems: Foreign Body In Patient

  MAUDE report 9126465 ↗
• MalfunctionMay 19, 2018Device Operates Differently Than Expected

  IT WAS REPORTED THAT THE WAND DID NOT PERFORM ANY FUNCTION. NO BACKUP DEVICE AVAILABLE.

  Patient problems: No Information

  MAUDE report 7528508 ↗
• MalfunctionMay 19, 2018Device Inoperable

  IT WAS REPORTED THAT THE WAND DID NOT PERFORM ANY FUNCTION. THERE WAS NO BACKUP DEVICE AVAILABLE.

  Patient problems: No Information

  MAUDE report 7528505 ↗
• MalfunctionMay 16, 2018Break

  IT WAS REPORTED THAT THE TIP OF THE DEVICE BROKE OFF INTO THE PATIENTS HEEL. BROKEN PIECE WAS REMOVED FROM THE PATIENT. A BACKUP DEVICE WAS AVAILABLE TO COMPLETE THE PROCEDURE WITH NO DELAY OR PATIENT INJURIES.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7520708 ↗