Coblation ASC4630-01Recalls & reported problems

Summary

The FDA's MAUDE database contains 64 adverse event reports that list this exact device (DI 00817470001921), received between Aug 24, 2018 and May 11, 2026 — classified as 28 injuries, 36 malfunctions.

The most frequently reported specific device problem is “Material Separation” (23 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 64 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 11, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A KNEE JOINT CLEANING, THE TIP OF THE TRISTAR 50 ICW ELECTRODE FELL OFF INSIDE THE PATIENT, THE PIECES WAS REMOVED WITH TWEEZERS. THE PROCEDURE WAS RESUMED, USING AN EQUIVALENT S+N BACK-UP. IT IS UNKNOWN IF THERE WAS A DELAY. THE PATIENT WAS FINE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25145018 ↗
• MalfunctionDec 30, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A SURGERY, THE TRISTAR 50 ICW WAND MISSED A PIECE OF IRON (WITH A DIAMETER OF ABOUT 0.4 CENTIMETERS). THE PROCEDURE WAS COMPLETED; HOWEVER, IT IS UNKNOWN IF THERE WAS SURGICAL DELAY. AFTER THE SURGERY, DURING INSTRUMENT COUNT, THE MISSING PIECE WAS NOTED, AND SUBSEQUENT X-RAY IMAGING DID NOT REVEAL ANY FRAGMENTS. NEVERTHELESS, THERE REMAINS A RISK THAT THE PIECE COULD HAVE BEEN RETAINED INSIDE THE PATIENT, DESPITE THE NEGATIVE X-RAY FINDINGS.

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 23921835 ↗
• MalfunctionOct 16, 2025Break; Break

  IT WAS REPORTED THAT DURING A ARTHROSCOPIC LIGAMENT RECONSTRUCTION OF KNEE, THE METAL ELECTRODE OF THE TRISTAR 50 WAND BROKE. THE ELECTRODE WAS REMOVED FROM INSIDE THE PATIENT USING TWEEZERS. THE PROCEDURE WAS PERFORMED, AFTER A 10 MINUTE DELAY, USING AN EQUIVALENT S+N BACK-UP. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23311804 ↗
• MalfunctionOct 9, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT, DURING A KNEE TENDON SURGERY, IT WAS NOTICED THAT THE ELECTRODE HEAD OF THE TRISTAR FELL OFF. THE PROCEDURE WAS RESUMED, AFTER A 10 MINUTE DELAY, USING AN EQUIVALENT S+N BACK UP DEVICE. ALL THE PIECES WERE REMOVED FROM THE PATIENT USING PLIERS AND TWEEZERS. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23263108 ↗
• MalfunctionAug 12, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN UNSPECIFIED PROCEDURE, ONE OF THE THREE SMALL BEADS AT THE FRONT END OF THE TRISTAR 50 ICW BLADE HAD FALLEN INTO THE INCISION, IT WAS NOTICED WHEN THE BLEEDING WAS STOPPED ON LOCAL TISSUES. THE BEAD WAS CLAMPED OUT WITH NUCLEUS PULPOSUS FORCEPS. 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 22784585 ↗
• InjuryJul 10, 2025Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT, DURING A MENISCUS REPAIR SURGERY, THE TRISTAR 50 WAND WAS USED WITHOUT A SUCTION DEVICE. AFTER THE SURGERY, WHICH WAS COMPLETED WITH THE SAME DEVICE, IT WAS FOUND THAT THE PATIENT'S SKIN HAD SUFFERED FIRST AND SECOND-DEGREE BURNS. THE BURNS WERE TREATED APPLYING PRESSURE TO PREVENT THE FORMATION OF BLISTERS. THE NEXT DAY THERE WERE BLISTERS THAT WERE REMOVED. THERE WAS NO SURGICAL DELAY REPORTED. THE PATIENT IS CURRENTLY RECOVERING FROM THE SCALDS.

  Patient problems: Partial thickness (Second Degree) Burn

  MAUDE report 22465629 ↗
• MalfunctionJun 27, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A TENDON RECONSTRUCTION PROCEDURE, A SCREW AT THE FRONT END OF THE TRISTAR 50 WAND WAS LOOSENED, AND IT WAS FOUND TO HAVE FALLEN OFF INSIDE THE PATIENT. IT WAS FOUND EMBEDDED IN THE CARTILAGE BY X-RAY AND WAS REMOVED DURING THE ORIGINAL PROCEDURE USING SUCTION. ANOTHER X-RAY CONFIRMED NO RESIDUE IN PATIENT. 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 22350042 ↗
• MalfunctionNov 1, 2024Material Erosion; Material Separation; Material Erosion; Material Separation

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, THE PLASMA ELECTRODE OF THE TRISTAR WAND FELL OFF INSIDE THE PATIENT AND WAS REMOVED BY RINSING WITH WATER. THE PROCEDURE WAS COMPLETED WITH NON-SIGNIFICANT SURGICAL DELAY, BUT IT IS UNKNOWN IF THERE WAS A BACK-UP DEVICE AVAILABLE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20593519 ↗
• MalfunctionNov 1, 2024Material Erosion; Material Separation; Material Erosion; Material Separation

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, THE METAL ELECTRODE AT THE FRONT END OF THE TRISTAR WAND FELL OFF DURING USE, AND IT WAS RETRIEVED FROM THE PATIENT BY SUCTION, IT WAS SEARCHED FOR IN THE ARTICULAR CAVITY AND FINALLY RINSED OUT WITH A LARGE AMOUNT OF SALINE SOLUTION. THE PROCEDURE WAS COMPLETED WITH NON-SIGNIFICANT SURGICAL DELAY, BUT IT IS UNKNOWN IF A BACK-UP DEVICE WAS USED, THE PROCEDURE WAS ALMOST DONE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20593132 ↗
• InjuryOct 22, 2024Break; Break

  IT WAS REPORTED THAT DURING A SHOULDER JOINT CLEANING SURGERY, THE METAL BLADE AT THE FRONT OF THE TRISTAR 50 WAND BUCKLED, CAUSING THE METAL POINT TO FALL OFF. THE FALLING FRAGMENT COULD NOT BE LOCATED, RAISING THE CONCERN THAT IT MAY HAVE BEEN LEFT IN THE PATIENT'S JOINT CAVITY. THE PROCEDURE WAS COMPLETED USING A COMPETITOR DEVICE, AND THERE WAS A DELAY OF LESS THAN 30 MINUTES NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 20510210 ↗
• InjuryDec 19, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT HAD PRIMARY ARTHROSCOPY SURGERY USING A TRISTAR 50 ICW IN SEPTEMBER 2023. THE PATIENT WAS RE-EXAMINED, AND AN X-RAY SHOWED FRAGMENTS OF METAL INSIDE THE PATIENT, THE WAND TIP FELL OFF WHEN USED AND WAS NOT DETECTED BY THE SURGEON. THE FRAGMENTS OF METAL CANNOT BE REMOVED FROM THE PATIENT'S BODY.

  Patient problems: Foreign Body In Patient

  MAUDE report 18358502 ↗
• MalfunctionJun 19, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, THE TIP ELECTRODE OF THE TRISTAR WAND CAME OFF. ALL THE PIECES WERE SUCCESSFULLY REMOVED FROM THE PATIENT. NON-SIGNIFICANT DELAY WAS REPORTED, AND THE PROCEDURE WAS FINISHED WITH A SMITH AND NEPHEW BACK UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17158419 ↗
• InjuryNov 21, 2022Material Separation; Material Separation

  IT WAS REPORTED THAT DURING A KNEE JOINT CLEANING, THE TRISTAR WAND TIP FELL OFF. THE BROKEN PIECE WAS REMOVED FROM THE PATIENT USING TWEEZERS. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A DELAY GREATER THAN 30 MINUTES, USING A BACK-UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15835050 ↗
• InjuryAug 8, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, THE METAL ELECTRODE OF A TRISTAR WAND FELL OFF. SURGERY WAS RESUMED WITHOUT ANY DELAY, WITH A BACK-UP DEVICE. PATIENT´S CURRENT HEALTH STATUS IS GOOD. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15188375 ↗
• MalfunctionAug 7, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE A TRISTAR WAND'S ELECTRODE GOT LOOSE. SURGERY WAS RESUMED, WITH A BACK-UP DEVICE, IT IS UNKNOWN IF THERE WERE ANY DELAYS. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15180707 ↗
• InjuryMay 6, 2022Break; Break

  IT WAS REPORTED THAT, DURING A MENISCUS REPAIR SURGERY, AN IRON STRIP OF A TRISTAR WAND GOT LOOSE AND A PART OF IT FELL OFF. ALL THE PIECES WERE REMOVED FROM THE PATIENT USING TWEEZERS. THE PROCEDURE WAS COMPLETED WITH NON-SIGNIFICANT DELAY USING A BACK-UP DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14310701 ↗
• InjuryApr 22, 2022Detachment of Device or Device Component; Material Integrity Problem; Detachment of Device or Device Component; Material Integrity Problem

  IT WAS REPORTED THAT, DURING AN ARTHROSCOPIC ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION, THE HEAD OF THE TRISTAR BLADE WAS DEFORMED DURING THE OPERATION, AND THE METAL DOTS FELL OFF. THE PIECES WERE REMOVED FROM THE PATIENT USING FORCEPS. SURGERY WAS RESUMED, WITH A BACK-UP DEVICE, AFTER A NON-SIGNIFICANT DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14182587 ↗
• InjuryMar 23, 2022Break; Break

  IT WAS REPORTED THAT, DURING A PROCEDURE, THE TIP ELECTRODE OF A TRISTAR WAND GOT BROKEN. THE BROKEN PIECES WERE REMOVED FROM THE PATIENT BODY. SURGERY WAS RESUMED, WITHOUT ANY DELAY, WITH A BACK-UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13860994 ↗
• MalfunctionFeb 4, 2022Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPIC REPAIR OF THE HIP GLENOID LIP, OUTSIDE THE PATIENT, THE ELECTRODE OF THE TRISTAR WAND FELL OFF. THE PROCEDURE WAS COMPLETED WITHOUT DELAY USING A BACK-UP DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13448357 ↗
• InjuryNov 24, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, DURING A SHOULDER CUFF REPAIR SURGERY USING A TRISTAR 50 WAND, THE WOUND WAS BURNED. THE PROCEDURE WAS FINISHED WITH A NON-SIGNIFICANT DELAY USING A SMITH AND NEPHEW BACK UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Burn(s)

  MAUDE report 12868226 ↗
• InjuryNov 4, 2021Break; Break

  IT WAS REPORTED THAT, DURING KNEE ARTHROSCOPIC SURGERY, THE ELECTRODE OF THE TRISTAR 50 ICW FELL OFF AND THE IRON SCREEN WAS BROKEN. THE ELECTRODE WAS NOT FOUND IN THE PATIENT, NOR SEEN IN THE X-RAY. PROCEDURE WAS COMPLETED AFTER A NON-SIGNIFICANT DELAY, WITH A BACK-UP DEVICE. NO OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12752623 ↗
• InjuryOct 27, 2021Overheating of Device; Unintended Electrical Shock; Overheating of Device; Unintended Electrical Shock

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, THE TRISTAR 50 WAND OVERHEATED AND THE USER FELT A TINGLING SENSATION. IT WAS NOT REPORTED IF THERE WERE ANY DELAYS IN A SURGICAL PROCEDURE OR IF A SMITH & NEPHEW DEVICE WAS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12707719 ↗
• InjuryOct 15, 2021Break; Break

  IT WAS REPORTED THAT DURING SURGERY THE DOCTOR USED A TRISTAR WAND IN ORDER TO STOP THE BLEEDING FROM THE PATIENT BUT THE METAL PIECE ON THE ELECTRODE FELL. THE PIECE WAS SUCCESSFULLY RETRIEVED FROM THE PATIENT WITH A GRIPPER. THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING A BACKUP DEVICE. WITHOUT A SIGINFICANT DELAY. NO OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12643230 ↗
• InjurySep 30, 2021Break; Break

  IT WAS REPORTED THAT, DURING REPAIR SURGERY, THE IRON STRIP AT THE TRISTAR 50 ICW WAND BECAME LOOSE AND A PART OF IT FELL OFF INSIDE OF THE PATIENT. ALL PIECES WERE RECOVERED FROM THE PATIENT USING TWEEZERS. PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY (LESS OR EQUAL TO 30MIN) WITH A BACK-UP DEVICE. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12553917 ↗
• MalfunctionSep 19, 2021Break; Break

  IT WAS REPORTED THAT THE TRISTAR METAL ELECTRODE FELT OFF. THE INCIDENT OCCURRED BEFORE THE PROCEDURE. A BACKUP DEVICE WAS AVAILABLE. NO COMPLICATIONS WERE REPORTED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12493578 ↗

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