Coblation ASC4730-01Recalls & reported problems

Summary

The FDA's MAUDE database contains 31 adverse event reports that list this exact device (DI 00817470006261), received between Jan 30, 2018 and Sep 22, 2026 — classified as 9 injuries, 22 malfunctions.

The most frequently reported specific device problem is “Break” (12 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 31 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 22, 2026Material Separation

  It was reported that, during a hip arthroscopy surgery, three metal tips of one (1) MULTIVAC 50 XL ICW became stuck at the operative site; however, they were removed using the shaver's suction. The procedure was resumed, without any delay, using an equivalent S+N back-up. No further complications were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50854092 ↗
• MalfunctionMay 15, 2026Break

  IT WAS REPORTED THAT, DURING A PROCEDURE, A MULTIVAC 50 XL HAD A DAMAGE ON ONE OF THE TIP METAL PLATES AFTER 5-MIN OF USE; IT APPEARED TO BE BENT AND ENDED UP COMING OFF. NOTHING REMAINED INSIDE THE JOINT. THE PROCEDURE WAS RESUMED USING A SIMILAR S+N BACK-UP PRODUCT. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25185003 ↗
• MalfunctionApr 14, 2026Material Separation; Activation Failure

  IT WAS REPORTED THAT DURING A HIP ARTHROSCOPY, THE MULTIVAC 50 WAND WAS ALSO NOT WORKING PROPERLY. CUTTING AND COAGULATION DID NOT FUNCTION, EVEN AT MAXIMUM SETTINGS, AND ONLY ONE OF THE THREE METALLIC CONTACT POINTS ON THE TIP WAS LIGHTING UP AND A PORTION OF THE SPACER WAS NOT VISIBLE IN THE IMAGE PROVIDED. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING A SIMILAR S+N BACK-UP PRODUCT. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24879052 ↗
• MalfunctionNov 21, 2025Break; Degraded; Break; Degraded

  IT WAS REPORTED THAT, DURING AN UNKNOWN PROCEDURE, THE MULTIVAC 50 WAND WAS USED ROUGHLY, WAS USED FOR MORE THAN AN HOUR AT A TIME, USING THE SHAVER VERY LITTLE, AND THE METAL TIP WORE OUT AND BROKE. ALL THE BROKEN PIECES WERE REMOVED. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING AN EQUIVALENT SN BACK-UP. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23624113 ↗
• MalfunctionOct 21, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT, DURING AN ARTHROSCOPY, IT WAS NOTICED THAT THE METAL TIP OF THE MULTIVAC 50 WAND CAME LOOSE FROM THE BODY, LEAVING IT LOOSE IN THE JOINT. THE PROCEDURE WAS RESUMED WITHOUT SURGICAL DELAY, USING AN EQUIVALENT SN BACKUP. NO FURTHER COMPLICATIONS WERE REPORTED.

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

  MAUDE report 23347600 ↗
• MalfunctionOct 8, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT, DURING A HIP ARTHROSCOPY, IT WAS NOTICED THAT ONE OF THE BALLS ON THE TIP OF A MULTIVAC WAND FELL OFF THE JOINT. IT TOOK 45 MINUTES TO RECOVER THE BALL. THE PROCEDURE WAS RESUMED, AFTER A DELAY GREATER THAN 30 MINUTES, WITH A CHANGE IN SURGICAL TECHNIQUE. ADDITIONAL ANESTHESIA WAS REQUIRED AS CONSEQUENCE OF THE SURGICAL PROLONGATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23245455 ↗
• MalfunctionJul 25, 2025Break; Detachment of Device or Device Component; Material Deformation; Break; Detachment of Device or Device Component; Material Deformation

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY SURGERY, THE MULTIVAC ICW WAND WAS BROKEN, SPECIFICALLY THE METALLIC PART. THE PROCEDURE WAS COMPLETED USING A S+N BACK UP DEVICE. THERE WAS NO SURGICAL DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22618863 ↗
• MalfunctionJul 2, 2025Detachment of Device or Device Component; Material Deformation; Detachment of Device or Device Component; Material Deformation

  IT WAS REPORTED THAT DURING A HIP ARTHROSCOPY FOR LABRAL REPAIR, THE METAL PLATE THAT IS ON THE FACE OF THE MULTIVAC 50 XL WAND BECAME BENT ON ONE END, AND THE SCREW HOLDING IT CAME OFF THE DEVICE. THE DETACHED PIECE WAS REMOVED 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 22391443 ↗
• MalfunctionJul 4, 2024Break; Break

  IT WAS REPORTED THAT DURING A HIP ARTHROSCOPY, THE TIP OF THE MULTIVAC 50 BROKE. ALL PIECES WERE REMOVED WITH A GRASPER TWICE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT SURGICAL DELAY USING A SMITH AND NEPHEW BACK UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19677296 ↗
• MalfunctionJun 17, 2024Break; Material Twisted/Bent; Break; Material Twisted/Bent

  IT WAS REPORTED THAT DURING A BILATERAL HIP ARTHROSCOPY, THE SURGEON PRESSED THE MULTIVAC 50 WAND TIP INSIDE THE PATIENT IN A WAY THAT BENT AND BROKE INSIDE THE PATIENT. THE DOCTOR WAS AWARE THAT HE DID NOT FOLLOW THE INSTRUCTIONS FOR USE. THE PROCEDURE WAS COMPLETED USING A S+N BACKUP DEVICE. IT IS UNKNOWN IF THERE WAS A DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19548132 ↗
• MalfunctionJan 5, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT DURING HIP ARTHROSCOPY, THE METAL AT THE TIP OF THE MULTIVAC WAND CAME OUT AND REMAINED INSIDE THE JOINT. THE SURGEON MANAGED TO REMOVE IT FORM PATIENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING A BACK-UP DEVICE. THERE WAS NO SURGICAL DELAY AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18455089 ↗
• InjurySep 7, 2022Break; Break

  IT WAS REPORTED THAT, DURING AN ARTHROSCOPY, IT WAS NOTICED THAT THE CUT WAS NOT TAKING PLACE CORRECTLY AND THE TIP OF THE MULTIVAC WAND WAS FOUND BROKEN, THE METALLIC PART OF THE TIP WAS FOUND INSIDE THE PATIENT. THE SMALL PIECE OF METAL WAS RETRIEVED FORM THE PATIENT BY BEING ASPIRATED. SURGERY WAS RESUMED AFTER A NON-SIGNIFICANT SURGICAL DELAY USING A BACK-UP DEVICE INSTEAD. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15368175 ↗
• InjurySep 5, 2022Break; Break

  IT WAS REPORTED THAT, DURING AN ARTHROSCOPY, IT WAS NOTICED THAT THE CUT WAS NOT TAKING PLACE CORRECTLY AND THE TIP OF THE MULTIVAC WAND WAS FOUND BROKEN, THE METALLIC PART OF THE TIP WAS FOUND INSIDE THE PATIENT. THE SMALL PIECE OF METAL WAS RETRIEVED FORM THE PATIENT BY BEING ASPIRATED. SURGERY WAS RESUMED AFTER A NON-SIGNIFICANT SURGICAL DELAY USING A BACK-UP DEVICE INSTEAD. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15355759 ↗
• InjuryApr 12, 2022Material Separation; Material Separation

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY PROCEDURE, THE TIP OF THE MULTIVAC WAND RELEASED A METALLIC PIECE THAT WAS AT THE TIP, INSIDE THE JOINT OF THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ONE-HOUR SURGICAL DELAY USING A BACK-UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 14084219 ↗
• InjurySep 22, 2021Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY PROCEDURE, A PARTIAL METAL IN THE TIP OF THE MULTIVAC COBLATION WAND BROKE IN THE HIP JOINT BUT THE PIECE WAS SUCCESSFULLY REMOVED FROM THE PATIENT USING A KELLY TWEEZER. THE PROCEDURE WAS COMPLETED WITHOUT DELAY USING THE SAME DEVICE THAT IT WAS STILL WORKING. NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12516095 ↗
• MalfunctionMay 28, 2021Material Separation; Material Separation

  IT WAS REPORTED THAT DURING SURGERY, WHILE MULTIVAC WAND WAS PUSHED THROUGH THE CANNULA, THE METAL TIP WITH THE SMALL PROBES ON THE END CAME UNDONE AND SEMI DETACHED FROM THE END OF THE WAND AND WAS HALF HOLDING ON. THE WAND WAS STILL FUNCTIONAL HOWEVER ONCE THE WAND WAS PULLED OUT AND PUT ON A STAND THE METAL END DID COME OFF. THE PROCEDURE WAS COMPLETED WITHOUT DELAY USING THE SAME DEVICE. NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11904988 ↗
• MalfunctionMay 28, 2021Material Separation; Material Separation

  IT WAS REPORTED THAT DURING SURGERY, WHILE MULTIVAC WAND WAS PUSHED THROUGH THE CANNULA, THE METAL TIP WITH THE SMALL PROBES ON THE END CAME UNDONE AND SEMI DETACHED FROM THE END OF THE WAND AND WAS HALF HOLDING ON. THE WAND WAS STILL FUNCTIONAL HOWEVER ONCE THE WAND WAS PULLED OUT AND PUT ON A STAND THE METAL END DID COME OFF. THE PROCEDURE WAS COMPLETED WITHOUT DELAY USING THE SAME DEVICE. NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11904984 ↗
• InjuryMar 18, 2021Break; Break

  IT WAS REPORTED THAT PIECES OF MULTIVAC WAND FELL OFF DURING A HIP SURGERY, THE DURATION/ ACTIVATION TIME FOR THE WAND WAS 5 MIN. THE PIECES WERE RETRIEVED WITH TWEEZERS AND THE PROCEDURE WAS COMPLETED WITH A SMITH AND NEPHEW BACK UP DEVICE. THERE WAS A DELAY OF LESS THAN OR EQUAL TO 30 MIN. 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: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11513254 ↗
• InjuryMar 17, 2021Break; Break

  IT WAS REPORTED THAT DURING A HIP PROCEDURE, THE WAND PIECES FELL OFF. THE PIECE WAS REMOVED FROM THE PATIENT USING GRASPING FORCEPS. BACKUP DEVICE WAS AVAILABLE TO COMPLETE THE PROCEDURE. NO SIGNIFICANT DELAY AND NO PATIENT 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 11509983 ↗
• MalfunctionMar 1, 2021Failure to Deliver Energy; Failure to Deliver Energy

  IT WAS REPORTED THAT DURING USE OF MULTIVAC 50 XL ICW, THE PRONGS WHEN INSERTED INTO THE APPROPRIATE PORT OF THE Q2 CONTROLLER DID NOT PERFORM ANY SOFT TISSUE ABLATION. THE CONTROL UNIT WAS WORKING PROPERLY BECAUSE THE ABLATION SIGNAL WAS PRESENT, THE PEDAL WAS WORKING. THE ABLATION WAS NOT WORKING. THE ISSUE WAS SOLVED WITH A COMPETITOR'S DEVICE AND THERE WAS A DELAY GREATER THAN 30 MINUTES. 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: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11392411 ↗
• MalfunctionMar 1, 2021Failure to Deliver Energy; Failure to Deliver Energy

  IT WAS REPORTED THAT DURING USE OF MULTIVAC 50 XL ICW, THE PRONGS WHEN INSERTED INTO THE APPROPRIATE PORT OF THE Q2 CONTROLLER DID NOT PERFORM ANY SOFT TISSUE ABLATION. THE CONTROL UNIT WAS WORKING PROPERLY BECAUSE THE ABLATION SIGNAL WAS PRESENT, THE PEDAL WAS WORKING. THE ABLATION WAS NOT WORKING. THIS WAS REPEATED WITH BOTH TIPS, OF DIFFERENT LOT. THE ISSUE WAS SOLVED WITH A COMPETITOR'S DEVICE AND THERE WAS A DELAY GREATER THAN 30 MINUTES. NO OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11391929 ↗
• InjuryNov 13, 2020Break; Break

  IT WAS REPORTED THAT DURING A SURGERY THE MUTIVAC WAND METAL TIP BROKE. IT IS UNKNOWN IF THERE WAS AN AVAILABLE BACK UP DEVICE OR A SIGNIFICANT DELAY DURING THE PROCEDURE. 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: No Information

  MAUDE report 10836634 ↗
• InjurySep 1, 2020Communication or Transmission Problem; Communication or Transmission Problem

  IT WAS REPORTED THAT DURING A HIP SCOPE, WHEN THE MULTIVAC WAND WAS CONNECTED TO THE CONTROLLER, NOTHING WOULD HAPPEN. THE SETTINGS COULD NOT BE MANUALLY CHANGED AND THE DISPLAY OF THE CONTROLLER SAID 0 FOR COAG AND ABLATE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT DELAY USING A DIFFERENT TYPE OF WAND(AMBIENT HIPVAC 50). 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: No Known Impact Or Consequence To Patient

  MAUDE report 10477237 ↗
• InjuryJul 17, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT, DURING AN ARTHROSCOPIC SURGERY, THE "MULTIVAC 50XLCOBLATION WAND" THE METAL PLATE OF THE WAND TIP WAS PARTIALLY DETACHED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT DELAY USING A BACK-UP DEVICE. NO FURTHER PROCEDURE 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 Information

  MAUDE report 10291796 ↗
• MalfunctionMar 12, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT, DURING A HIP ARTHROSCOPY, THE MULTIVAC 50 XL WAND LOST A METAL BEAD INSIDE THE PATIENT, WHICH WAS THEN REMOVED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT SIGNIFICANT DELAY USING A BACK-UP DEVICE. NO PATIENT INJURIES 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 9826459 ↗

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