Coblation ASC4250-01Recalls & reported problems

Summary

The FDA's MAUDE database contains 169 adverse event reports that list this exact device (DI 00817470006421), received between Oct 5, 2017 and Sep 23, 2026 — classified as 63 injuries, 106 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (33 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 169 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 23, 2026Crack; Detachment of Device or Device Component

  It was reported that, during surgery, the tip of two (2) SUPER TURBOVAC 90 ICW was cracked and fell off. however, the broken pieces were removed with tweezers. The procedure was resumed, with a non-significant delay, using an equivalent S+N back-up. No further complications were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50863657 ↗
• InjurySep 18, 2026Overheating of Device

  It was reported that, during a shoulder arthroscopy surgery, one (1) SUPER TURBOVAC 90 ICW caused a second-degree skin burn at site where the black cable of the device has contact. A whitish appearance was observed at the edge of the incision. The procedure was resumed without any delay using the same S+N product. No further complications were reported.

  Patient problems: Partial thickness (Second Degree) Burn

  MAUDE report 50813254 ↗
• MalfunctionSep 3, 2026Detachment of Device or Device Component

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50576960 ↗
• MalfunctionSep 3, 2026Detachment of Device or Device Component

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50576892 ↗
• MalfunctionAug 31, 2026Detachment of Device or Device Component

  It was reported that, during rotator cuff suture surgery, part of the electrode of one (1) SUPER TURBOVAC 90 ICW fell off. The procedure was performed, using an equivalent S+N back-up; however, it is unknown if there was any surgical delay. No further complications were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50524783 ↗
• MalfunctionAug 13, 2026Overheating of Device

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50245178 ↗
• MalfunctionJun 27, 2026Break

  IT WAS REPORTED THAT, DURING A SURGERY, THE ELECTRODE TIP OF ONE (1) SUPER TURBOVAC FELL OFF. THE PROCEDURE WAS RESUMED USING AN EQUIVALENT S+N BACK-UP. IT IS UNKNOWN IF THERE WAS A DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25647152 ↗
• MalfunctionJun 1, 2026Overheating of Device; Infusion or Flow Problem

  IT WAS REPORTED THAT, DURING A SURGERY, ONE (1) SUPER TURBOVAC WAND PRODUCED TOO MANY BUBBLES, WHICH INTERFERED WITH THE VIEW AND MADE IT IMPOSSIBLE TO CONTINUE USING IT, AND THE HANDLE WAS VERY HOT. THE PROCEDURE WAS RESUMED 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 25352864 ↗
• InjuryMay 21, 2026Break; Detachment of Device or Device Component

  IT WAS REPORTED THAT, DURING A PROCEDURE, A SUPER TURBOVAC 90 METAL COVER PLATE FELL OFF AND BROKE IN TWO PIECES. ONLY ONE OF THE PIECES COULD BE FOUND AFTER AN EXTENSIVE SEARCH. IT WAS NOT FELT IN THE JOINT, IT WAS FELT IN THE SOFT TISSUE. IT IS UNKNOWN HOW THE PROCEDURE WAS PERFORMED OR IF THERE WAS A SURGICAL DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 25237806 ↗
• MalfunctionFeb 10, 2026Material Separation

  IT WAS REPORTED THAT DURING A SHOULDER PROCEDURE, THE BLACK PLASTIC TUBE AT THE FRONT END OF THE SHAFT OF ONE (1) SUPER TURBOVAC 90 FELL OFF. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, USING AN EQUIVALENT S+N BACK-UP. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24304243 ↗
• MalfunctionFeb 3, 2026Activation Failure

  IT WAS REPORTED THAT DURING A SHOULDER PROCEDURE, THE SUPER TURBOVAC 90 WAS NOT RESPONDING AFTER BEING CONNECTED TO THE CABLE SOCKET AND THE FOOT PEDAL WAS PRESSED. THE PROCEDURE WAS RESUMED USING AN EQUIVALENT S+N BACKUP. AFTER A DELAY GREATER THAN 30 MINUTES. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24247273 ↗
• MalfunctionFeb 3, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A SHOULDER PROCEDURE, THE METAL TIP OF THE SUPER TUBOVAC 90 WAND HAD BURNED AND FELL OFF INSIDE THE PATIENT. THE TIP WAS REMOVED FROM INSIDE THE PATIENT USING SUCTION. THE PROCEDURE WAS RESUMED USING AN EQUIVALENT S+N BACKUP, AFTER A DELAY GREATER THAN 30 MINUTES. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24247085 ↗
• MalfunctionFeb 3, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT, DURING A HIP ARTHROSCOPY, ONE OF THE METAL BALLS ON THE END OF A SUPER TURBOVAC 90 CAME OFF. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING THE SAME DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24245585 ↗
• MalfunctionJan 21, 2026Delivered as Unsterile Product

  IT WAS REPORTED THAT, DURING AN ARTHROSCOPY, A SUPER TURBOVAC WAND'S PACKAGE WAS NOT SEALED, NOT STERILE. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING A SIMILAR S+N BACK-UP. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24132042 ↗
• MalfunctionJan 8, 2026Degraded; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A ROTATOR CUFF PROCEDURE, IT WAS NOTICED THAT THE SUPER TURBOVAC 90 ICW FAILED, ITS ELECTRODE HEAD FELL OFF. THE ELECTRODE FELL INSIDE THE PATIENT BUT IT WAS REMOVED BY SUCTION. THE PROCEDURE WAS RESUMED AFTER A NON-SIGNIFICANT SURGICAL DELAY, USING AN EQUIVALENT SMITH AND NEPHEW BACK UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24011174 ↗
• MalfunctionJan 6, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT, DURING A ROTATOR CUFF REPAIR PROCEDURE, THE METAL TIP OF THE SUPER TURBOVAC WAND FELL OFF. THE PROCEDURE WAS RESUMED, WITH A NON SIGNIFICANT DELAY, USING AN EQUIVALENT S+N BACK-UP. STATUS OF THE PATIENT IS GOOD AND IT IS NOT CONFIRMED IF THE METAL TIP WAS SUCKED OUT. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23977598 ↗
• MalfunctionDec 29, 2025Degraded; Detachment of Device or Device Component; Degraded; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A ROTATOR CUFF PROCEDURE, IT WAS NOTICED THAT THE ELECTRODE OF THE SUPER TURBOVAC 50 ICW FELL OFF. THE DETACHED TIP WAS RETRIEVED FROM THE PATIENT USING TWEEZERS. THE PROCEDURE WAS RESUMED AFTER A NON-SIGNIFICANT SURGICAL DELAY USING AN EQUIVALENT S+N BACK-UP PRODUCT. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23907452 ↗
• MalfunctionNov 6, 2025Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT DURING AN UNSPECIFIED PROCEDURE, THE ELECTRODE OF THE HANDLE AND SHAFT OF THE SUPER TURBOVAC 90 ICW BECAME UNUSUALLY WARM, THE ELECTRODE TIP IN THE JOINT HAD A MUCH BRIGHTER LIGHT VISIBLE, INSTEAD OF THE USUAL GLOWING LIGHT (NACL). THE IRRIGATION FLUID WAS ALSO NOTICEABLY WARMER THAN USUAL. THE PROCEDURE WAS RESUMED, USING AN EQUIVALENT S+N BACK-UP, HOWEVER IT IS UNKNOWN IF THERE WAS ANY SURGICAL DELAY. NO HARM OR FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23483442 ↗
• MalfunctionNov 3, 2025Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT DURING A SHOULDER ARTHROSCOPY, THE ELECTRODE OF THE HANDLE AND SHAFT OF THE SUPER TURBOVAC 90 ICW BECAME UNUSUALLY WARM, THE ELECTRODE TIP IN THE JOINT HAD A MUCH BRIGHTER LIGHT VISIBLE, INSTEAD OF THE USUAL GLOWING LIGHT (NACL). THE IRRIGATION FLUID WAS ALSO NOTICEABLY WARMER THAN USUAL. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING AN EQUIVALENT S+N BACK-UP. NO HARM OR FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23460396 ↗
• MalfunctionNov 3, 2025Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT DURING AN UNSPECIFIED PROCEDURE, THE ELECTRODE OF THE HANDLE AND SHAFT OF THE SUPER TURBOVAC 90 ICW BECAME UNUSUALLY WARM, THE ELECTRODE TIP IN THE JOINT HAD A MUCH BRIGHTER LIGHT VISIBLE, INSTEAD OF THE USUAL GLOWING LIGHT (NACL). THE IRRIGATION FLUID WAS ALSO NOTICEABLY WARMER THAN USUAL. THE PROCEDURE WAS RESUMED, USING AN EQUIVALENT S+N BACK-UP, HOWEVER IT IS UNKNOWN IF THERE WAS ANY SURGICAL DELAY. NO HARM OR FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23459815 ↗
• InjuryOct 31, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER A SHOULDER ARTHROSCOPY THAT HAD BEEN PERFORMED ON (B)(6) 2025 WITH A SUPER TURBOVAC WAND, UPON THE REMOVAL OF THE SURGICAL DRAPES, A SECOND-DEGREE BURN WAS OBSERVED IN THE LEFT INFRACLAVICULAR REGION. THE CLINIC INDICATES THAT AS OF (B)(6) 2025, THE PATIENT WAS IN THE PROCESS OF HEALING FROM THE BURN, UNDERGOING FOLLOW UP BY THE ORTHOPEDIST. THE PATIENT WAS LEFT WITH A SMALL FIRST-DEGREE BURN ON HIS LEFT PECTORAL REGION, WHICH IS BEING TREATED BY THE INSTITUTION. THE SIZE OF THE BURN WAS 3X 5 CM AND WAS TREATED WITH MEDICAL DRESSING. THE NOT AFFECTED TISSUE HAD NO SPECIFIC PROTECTION CARRIED OUT.

  Patient problems: Partial thickness (Second Degree) Burn

  MAUDE report 23442264 ↗
• MalfunctionOct 20, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT, DURING A LEFT SHOULDER ROTATOR CUFF REPAIR, AFTER COMPLETING THE REPAIR, IT WAS NOTICED THAT A PARTIAL MISSING WAS FOUND AT THE ELECTRODE OF A SUPER TURBOVAC WAND. THE PATIENT WAS IRRADIATED WITH A C-ARM MACHINE AT THE SURGICAL SITE, AND NO OBVIOUS FOREIGN OBJECTS WERE OBSERVED IN THE INCISION. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT SURGICAL DELAY, USING THE SAME DEVICE. THE PATIENT WAS DISCHARGED ON (B)(6), AND NO OBVIOUS ABNORMALITIES WERE FOUND. THE PATIENT'S STATUS IS FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23335793 ↗
• InjuryJul 13, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A KNEE JOINT PROCEDURE, ONE ELECTRODE METAL PARTICLE OF THE SUPER TURBOVAC FELL INTO THE JOINT CAVITY AND COULD NOT BE REMOVED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A SURGICAL DELAY GREATER THAN 30 MINUTES USING A SMITH AND NEPHEW BACK UP DEVICE. THE PATIENT IS ACTUALLY FINE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 22491112 ↗
• MalfunctionJul 2, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A HIP ARTHROSCOPY, THE TIP OF THE SUPER TURBOVAC WAND FELL OFF INTO THE JOINT SPACE. THE DETACHED TIP WAS REMOVED WITH AN ARTHROSCOPIC GRASPER FROM THE PATIENT. THE SURGERY WAS COMPLETED WITH A SMITH AND NEPHEW BACK-UP DEVICE. THERE WAS A DELAY OF LESS THAN 30 MINUTES, AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22391701 ↗
• MalfunctionJun 17, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING THE ARTHROSCOPIC SURGERY ON THE LEFT ELBOW, THE TIP OF THE SUPER TURBOVAC WAND WAS MISSING. THE MISSING PART WAS FOUND AT THE PATIENT'S ELBOW JOINT AND WAS SUCTIONED OUT. THE SURGERY CONTINUED, AND AFTER THE SURGERY, THE RADIOLOGY DEPARTMENT WAS ASKED TO TAKE X-RAYS. NO RESIDUAL DISCS WERE FOUND IN THE PATIENT'S ELBOW JOINT. IT IS UNKNOWN IF THERE WAS A BACK-UP DEVICE AVAILABLE OR IF THERE WAS A SURGICAL DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22233881 ↗