Coblation ASC1336-01Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 00817470006520), received between Nov 28, 2017 and Apr 24, 2023 — classified as 8 injuries, 7 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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• InjuryApr 24, 2023Failure to Deliver Energy; Failure to Deliver Energy

  IT WAS REPORTED THAT ON THE PMCF "PMCF FOR TURBOVAC 90 XL ICW, MULTIVAC 50 XL ICW & TOPAZ EZ IFS", WAS FOUND THAT DURING A PROCEDURE, A TURBOVAC 90 XL ICW WAND DID NOT PRODUCE THE EXPECTED DEGREE OF COAGULATION. THE PATIENT HAD TO BE REVISED DUE TO REBLEEDING. PATIENTS¿ OUTCOME IS UNKNOWN. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 16799589 ↗
• InjuryApr 24, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON THE PMCF "PMCF FOR TURBOVAC 90 XL ICW, MULTIVAC 50 XL ICW & TOPAZ EZ IFS", WAS FOUND THAT DURING A PROCEDURE USING A TURBOVAC 90 XL ICW WAND THERE WAS AN UNWANTED TISSUE DAMAGE AND BLEEDING; WHICH LED TO A POST OPERATIVE BLEEDING AND STIFFNES IN THE JOINT. IT IS UNKNOWN HOW THE EVENTS WERE TREATED. PATIENTS¿ OUTCOME IS UNKNOWN. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Loss of Range of Motion; Unspecified Tissue Injury

  MAUDE report 16796949 ↗
• InjuryApr 22, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON THE PMCF "PMCF FOR TURBOVAC 90 XL ICW, MULTIVAC 50 XL ICW & TOPAZ EZ IFS", WAS FOUND THAT DURING A PROCEDURE USING A TURBOVAC 90 XL ICW WAND THERE WAS AN UNWANTED SLIGHT DAMAGE TO THE FEMORAL ARTICULATED CARTILAGE FROM THE HEAT OF THE HEAD OF THE WAND. IT IS UNKNOWN HOW THE EVENT WAS TREATED. PATIENTS¿ OUTCOME IS UNKNOWN. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 16792663 ↗
• InjuryMar 15, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A HIP ARTHROSCOPY , THE TURBOVAC'S DISTAL ELECTRODE FELL OFF. THE PATIENT HAD X-RAY AND THE TIP WAS FOUND IN THE TISSUE OUTSIDE OF THE HIP JOINT. THE PIECE WAS LEFT IN SITU IN A POSITION OUTSIDE OF THE HIP JOINT AS MINIMAL RISK OF DAMAGE. THE SURGERY WAS COMPLETED WITHOUT ANY SURGICAL DELAY USING A BACK-UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 16547827 ↗
• InjuryNov 1, 2021Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, THE TIP CENTRAL PART OF THE TURBOVAC WAND DISCONNECTED WHEN USING. THE METAL PART COULD NOT BE REMOVED FROM PATIENT HIP JOINT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT DELAY USING A BACK-UP DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 12734170 ↗
• InjuryMar 19, 2021Break; Break

  IT WAS REPORTED THAT DURING SURGERY, THE TURBOVAC 90 XL ICW WAS BEING UTILIZED IN THE INTENDED MANNER WHEN THE DISTAL PORTION OF THE INSTRUMENT CAME OFF WITHIN THE PATIENT. THE BROKEN PIECE WAS NOT RETRIEVED FROM PATIENT. IT IS UNKNOWN WHETHER THERE WAS A BACK UP AVAILABLE OR DELAY IN THE CASE. NO 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: Foreign Body In Patient

  MAUDE report 11522260 ↗
• MalfunctionMar 20, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT DURING A HIP ARTHROSCOPY PROCEDURE, THE WAND WAS NOT FIXING, THE RADIO FREQUENCY TIP DOES NOT FIT. A BACKUP DEVICE WAS AVAILABLE TO COMPLETE THE PROCEDURE. THERE WAS A DELAY GREATER THAN 30 MINUTES IN THE PROCEDURE HOWEVER 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 Known Impact Or Consequence To Patient

  MAUDE report 9860874 ↗
• MalfunctionOct 8, 2019Corroded

  IT WAS REPORTED THAT DURING A PROCEDURE, THE DEVICE HAD A CORROSION STAINS, IT WAS NOTICED WHEN THE PACKAGING WAS OPENED. PROCEDURE WAS COMPLETED WITH THE SAME DEVICE. NO DELAY AND NO PATIENT INJURIES WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9167591 ↗
• MalfunctionSep 22, 2019Corroded; Corroded

  IT WAS REPORTED THAT DURING A HIP ARTHROSCOPY, THE DEVICE WAS OXIDIZED INSIDE THE BOX, THE DOCTOR DECIDED TO USE IT IN THE PATIENT BECAUSE HE WAS ANESTHETIZED AND NO OTHER DEVICE WAS AVAILABLE. THE PROCEDURE WAS COMPLETED WITH THE SAME DEVICE WITH NO DELAY OR PATIENT INJURY REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9102252 ↗
• MalfunctionSep 4, 2019Material Separation; Material Separation

  IT WAS REPORTED THAT THE FACE PLATE ELECTRODE CAME OFF FROM THE SHAFT DURING A HIP ARTHROSCOPY. IT IS BELIEVED IT WAS CAUGHT ON THE EDGE OF THE SLOTTED CANNULA WHEN EXCITING THE JOINT DISLODGING IT FROM THE WANDS SHAFT. THE ELECTRODE WAS UNABLE TO BE RECOVERED FROM THE PATIENT AND THERE WAS A SURGICAL DELAY GREATER THAN 30 MINUTES. A BACKUP DEVICE WAS AVAILABLE TO COMPLETE THE PROCEDURE WITH NO PATIENT INJURIES.

  Patient problems: Foreign Body In Patient

  MAUDE report 8960799 ↗
• InjuryApr 15, 2019Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AT THE END OF THE PROCEDURE A BURN INJURY WAS FOUND IN THE LEFT THIGH OF THE PATIENT.

  Patient problems: Burn, Thermal

  MAUDE report 8516507 ↗
• MalfunctionMay 26, 2018Detachment Of Device Component

  IT WAS REPORTED THAT IT WAS VISUALIZED ON THE MONITOR THAT THE PLATE AND THE ACTIVE ELECTRODES WERE DETACHED;. DOCTOR COMPLETED THE PROCEDURE AND THE ELEMENT THAT HAD BEEN DETACHED WAS REMOVED. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7547001 ↗
• MalfunctionMar 21, 2018No Display/Image; Display or Visual Feedback Problem; Connection Problem

  IT WAS REPORTED THAT DURING THE USE OF THE TIP IN THE FUNCTION OF CUTTING WITH THE PEDAL, THE IMAGE DISAPPEARED OF THE MONITOR, ACCORDING TO ORIENTATION THE CABINET AND THE COBLATION WERE CONNECTED IN DIFFERENT NETWORKS, BUT IT DID NOT WORK. THE HDMI AND BNC CABLES WERE CHANGED AND THE RECORDING ON THE CAPTURE CARD WAS INTERRUPTED, SO THE TIP WORKED NORMALLY. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7358205 ↗
• MalfunctionNov 30, 2017Overheating of Device; Peeled/Delaminated; Component Missing

  IT WAS REPORTED DURING SURGERY WHEN THE STARVAC COBLATION WAND WAS USED, THERE WAS NO PROBLEM AT THE BEGINNING, BUT WHEN IT WAS USED CONTINUOUSLY, THE DOCTOR REALIZED THROUGH THE SCREEN THAT THE BODY OF THE WAND WAS PEELED; HE NOTICED THAT A COATING WAS MISSING IN THE BODY OF THE PRODUCT, LIKEWISE, HE NOTICED THAT THERE WERE NOT 4 PIN IN THE HEAD OF THE TIP HE JUST FOUND 2 PINS AND THEY DID NOT HEAT UP (PLASMA LAYER). HE PASSED ANOTHER UNIT (SAME REFERENCE) AND THE PROCEDURE WAS COMPLETED. THE PRODUCT WAS OPENED INSIDE THE OPERATING ROOM AND IT WAS GIVEN TO THE INSTRUMENTALIST TO REACH IT TO THE DOCTOR, THERE WAS NO OTHER PERSON TO MANIPULATE THE PRODUCT. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7070485 ↗
• InjuryNov 28, 2017Insufficient Heating; Peeled/Delaminated; Packaging Problem

  IT WAS REPORTED DURING SURGERY WHEN THE STARVAC COBLATION WAND WAS USED, THERE WAS NO PROBLEM AT THE BEGINNING, BUT WHEN IT WAS USED CONTINUOUSLY, THE DOCTOR REALIZED THROUGH THE SCREEN THAT THE BODY OF THE WAND WAS PEELED; HE NOTICED THAT A COATING WAS MISSING IN THE BODY OF THE PRODUCT, LIKEWISE, HE NOTICED THAT THERE WERE NOT 4 PIN IN THE HEAD OF THE TIP HE JUST FOUND 2 PINS AND THEY DID NOT HEAT UP (PLASMA LAYER). HE PASSED ANOTHER UNIT (SAME REFERENCE) AND THE PROCEDURE WAS COMPLETED. THE PRODUCT WAS OPENED INSIDE THE OPERATING ROOM AND IT WAS GIVEN TO THE INSTRUMENTALIST TO REACH IT TO THE DOCTOR, THERE WAS NO OTHER PERSON TO MANIPULATE THE PRODUCT. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7065552 ↗

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