Coblation ASHA4830-01Recalls & reported problems

Summary

The FDA's MAUDE database contains 121 adverse event reports that list this exact device (DI 00817470006551), received between Sep 6, 2017 and Jul 13, 2025 — classified as 26 injuries, 95 malfunctions.

The most frequently reported specific device problem is “Material Separation” (29 reports).

1 other recall cover devices cleared under the same FDA submission (K083306, K180848); 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 121 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 13, 2025Failure to Conduct; Failure to Conduct

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, TWO AMBIENT SUPER MULTIVAC WANDS PRESENTED AN E3 ERROR AFTER USE FOR LESS THAN 10 MINUTES SINCE EACH WAND WAS PLUGGED IN. THE PROCEDURE WAS COMPLETED USING AN S+N BACKUP DEVICE. THERE WAS A DELAY OF 45 MINUTES. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22491230 ↗
• MalfunctionJun 30, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, AFTER ABOUT A MINUTE OF USE, THE AMBIENT SUPER MULTIVAC ELECTRODE TIP FELL OFF INSIDE THE PATIENT¿S BODY. THE ELECTRODE TIP WAS RETRIEVED FROM THE PATIENT. THE PROCEDURE WAS COMPLETED USING A SMITH AND NEPHEW BACK UP DEVICE. THERE WAS NO SURGICAL DELAY AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22355158 ↗
• MalfunctionApr 29, 2025Arcing; Explosion; Arcing; Explosion

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, UPON PUTTING THE AMBIENT SUPER TURBOVAC IN THE JOINT, IT SPARKED AND EXPLODED. THE METAL FACE OF THE WAND WAS SHOT INTO SOME SOFT TISSUE. THE PIECE WAS ABLE TO BE REMOVED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A DELAY OF LESS THAN 30 MINUTES USING A SMITH AND NEPHEW BACK UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21926074 ↗
• InjuryMar 6, 2025Self-Activation or Keying; Self-Activation or Keying

  IT WAS REPORTED THAT AFTER A PROCEDURE, THE ABLATE OR COAGULATE FUNCTION OF THE SUPER MULTIVAC WAND WAS ACTIVATED EVEN THOUGH NO HAND BUTTON OR FOOT PEDAL WAS PRESSED. THE PATIENT WAS FOUND TO HAVE BURNS, THE PATIENT HAD BLISTERS. THE SURGICAL STOCKINETTE WAS BURNT. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Blister; Burn(s); Full thickness (Third Degree) Burn

  MAUDE report 21543186 ↗
• MalfunctionAug 28, 2024Degraded; Detachment of Device or Device Component; Degraded; Detachment of Device or Device Component

  IT WAS REPORTED THAT, DURING A MENISCUS REPAIR PROCEDURE, THE ELECTRODE OF THE MULTIVAC WAND FELL OFF. THE ELECTRODE WAS RETRIEVED USING GRASPERS. SURGERY WAS COMPLETED WITH A BACK-UP DEVICE INSTEAD. THERE WAS A SURGICAL DELAY OF LESS THAN 30 MINUTES, AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20087651 ↗
• InjuryJul 8, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT DURING A PROCEDURE, THE TIP OF THE AMBIENT SUPER MULTIVAC 50 WAND CAME OFF AND GOT LOST INSIDE THE HIP JOINT SPACE OF THE PATIENT. PIECES WERE NOT REMOVED FROM THE PATIENT. THE PROCEDURE WAS COMPLETED USING A SMITH AND NEPHEW BACK UP DEVICE. THERE WAS A DELAY GREATER THAN 30 MINUTES AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 19696926 ↗
• MalfunctionApr 10, 2024Failure to Conduct; Failure to Conduct

  IT WAS REPORTED THAT DURING A ROTATOR CUFF REPAIR, TWO (2) AMBIENT SUPER MULTIVAC 50 WANDS SHOWED ERROR CODE E8 ¿ WAND ERROR AND ERROR CODE E3 WHEN CONNECTED TO THE QUANTUM II CONSOLE. THE PROCEDURE WAS COMPLETED WITH A SURGICAL 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 19080472 ↗
• MalfunctionJan 3, 2024Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, A PIECE OF THE AMBIENT SUPER MULTIVAC WAND BROKE OFF INSIDE OF THE PATIENT. THE BROKEN PIECE WAS RETRIEVED. 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 18436312 ↗
• MalfunctionNov 15, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT DURING AN ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION SURGERY, THE ELECTRODE OF THE AMBIENT SUPER MULTIVAC WAND DETACHED FROM THE TIP AND FELL OFF INSIDE THE PATIENT. IT WAS REMOVED WITH SUCTION AND TWEEZERS. THE PROCEDURE WAS COMPLETED WITH NON-SIGNIFICANT DELAY USING A BACK-UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18145935 ↗
• InjuryAug 8, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT AFTER SURGERY, ON (B)(6)2023, THE TIP OF THE AMBIENT SUPER MULTIVAC WAND WAS DISCOVERED INSIDE THE PATIENT, ON A POST-OPERATIVE RADIOGRAPHY. DURING AN ARTHROSCOPY, THE TIP OF THE ELECTRODE FELL OFF . THE OUTPUT TIME OF THE WAND WAS ABOUT 2 MINUTES. THE PROCEDURE WAS COMPLETED WITH A 10-MINUTE SURGICAL DELAY. A REVISION SURGERY WAS PERFORMED ON (B)(6)2023, TO RETRIEVE THE TIP OF THE ELECTRODE FROM THE PATIENT'S BODY. NO FURTHER COMPLICATIONS WERE REPORTED. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Foreign Body In Patient

  MAUDE report 17483461 ↗
• MalfunctionJul 17, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT DURING A PROCEDURE, THE PLATE ON THE TIP OF THE SUPER MULTIVAC 50 BROKE AWAY. THE PIECE WAS RETRIEVED INTRAOPERATIVELY. THE PROCEDURE WAS COMPLETED WITHOUT SURGICAL DELAY. 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 17333253 ↗
• InjuryMay 12, 2023Break; Break

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE; AN AMBIENT SUPER MULTIVAC 50 TINY PLASTIC PART END OF AROUND 1-2MM WAS LOST INSIDE THE PATIENT. THE PART WAS SEARCHED FOR WITH A SCOPE AND USING X-RAY DURING THE PROCEDURE; HOWEVER IT WAS NOT FOUND; THEREFORE THE SURGEON DECIDED TO LEAVE IT. IT IS UNKNOWN IF THERE WAS A NEED FOR A BACK-UP DEVICE OR IF THERE WAS ANY DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 16923743 ↗
• InjuryJan 12, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT DURING AN ACL, AN AMBIENT SUPER MULTIVAC´S TIP ELECTRODE FELL OFF. THE BROKEN PIECES WERE REMOVED FROM THE PATIENT. SURGERY RESUMED AFTER A NON-SIGNIFICANT DELAY, HOWEVER IT IS UNKNOWN, HOW THE PROCEDURE WAS FINISHED. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16148018 ↗
• InjuryJan 2, 2023Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY THE MULTIVAC WAND ELECTRODE TIP FELL OF. SINCE THE TIP WAS NOT FOUND IN THE PATIENT'S BODY, IT WAS DETERMINED THAT IT HAD FLOWED OUT. IT IS UNKNOWN HOW THE PROCEDURE WAS FINISHED AND IF THERE WAS A DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16082960 ↗
• InjuryJun 8, 2022Material Separation; Material Separation

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY PROCEDURE USING SUPERMULTIVAC WAND, THE TIP ELECTRODE FELL OFF. THE FRAGMENT WAS REMOVED FROM THE PATIENT. THE PROCEDURE WAS COMPLETED WITHOUT SURGICAL DELAY USING A BACK-UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14640307 ↗
• InjuryDec 3, 2021Break; Break

  IT WAS REPORTED THAT DURING A KNEE ARTHROSCOPY, THE PLATE SEPARATED FROM THE AMBIENT TIP/SHAFT. A PART OF THE METAL PLATE THAT CAME OFF WAS SAVED AND PLACED IN A SPECIMEN JAR. THE BROKEN PIECE WAS RETRIEVED USING GRASPERS AND ACCORDING TO REPORTS, THE PATIENT¿S KNEE WAS XR TO ENSURE NO PIECE REMAINED. IT IS UNKNOWN IF A BACKUP DEVICE WAS AVAILABLE AND HOW THE ISSUE WAS RESOLVED. THERE WAS A SIGNIFICANT DELAY AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12928920 ↗
• MalfunctionJul 15, 2021Material Separation; Material Separation

  IT WAS REPORTED THAT DURING A SURGERY A SMALL PIECE OF THE ELECTRODE TIP OF THE AMBIENT SUPER MULTIVAC WAND WAS BROKEN. IT WAS RETRIEVED FROM THE PATIENT WITH A GRASPER. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT DELAY. IT IS UNKNOWN IF THERE WAS AN AVAILABLE BACK UP DEVICE. NO OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12171091 ↗
• MalfunctionJul 9, 2021Protective Measures Problem; Protective Measures Problem

  IT WAS REPORTED THAT DURING A KNEE SCOPE SURGERY THE AMBIENT SUPER MULTIVAC WAS CONNECTED TO A QUANTUM II CONSOLE AND IT SHOWED A WAND ERROR E8. THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING A BACK-UP DEVICE. A DELAY GREATER THAN 30 MINUTES WAS REPORTED. NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12142273 ↗
• MalfunctionJul 9, 2021Failure to Deliver Energy; Failure to Deliver Energy

  IT WAS REPORTED THAT DURING A KNEE SCOPE SURGERY, THE AMBIENT SUPER MULTIVAC WAS CONNECTED TO THE QUANTUM II CONSOLE AND WHEN THE HAND CONTROL OR THE FOOT CONTROL WERE WAS PRESSED, THE DEVICE DID NOT RESPOND AND IT WAS UNABLE TO BURN. THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING A BACK-UP DEVICE. A DELAY GREATER THAN 30 MINUTES WAS REPORTED. NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12142223 ↗
• InjuryJun 3, 2021Break; Break

  IT WAS REPORTED THAT, DURING AN ARTHROSCOPY, THE TIP OF THE COBLATION WAND BROKE OFF WHILE BEING USED IN THE PATIENT¿S JOINT. THE SURGEON THEN HAD TO RETRIEVE THE BROKEN PIECE WHICH WAS VERY SMALL AND DIFFICULT TO DO. THE PIECE WAS RETRIEVED USING SUCTION FROM THE SHAVER AND A GRASPER TO PULL IT OUT OF THE JOINT. THIS CAUSED A DELAY OF APPROXIMATELY 15 MIN IN THE SURGICAL PROCESS. A SECOND WAND OF THE SAME PART NUMBER WAS USED TO COMPLETE THE PROCEDURE. NO OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11930644 ↗
• MalfunctionApr 30, 2021Protective Measures Problem; Protective Measures Problem

  IT WAS REPORTED THAT, DURING A KNEE SCOPE PROCEDURE, THE WANDS AMBIENT SUPER MULTIVAC DISPLAYED ERROR CODE E8 "WAND ERROR" ON THE QUANTUM II CONSOLE. THE PROCEDURE WAS COMPLETED WITH A BACKUP DEVICE WITH NO FURTHER COMPLICATION. A DELAY GREATER THAN 30 MINUTES WAS 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 11757987 ↗
• MalfunctionApr 5, 2021Electrical Shorting; Electrical Shorting

  IT WAS REPORTED THAT, BEFORE AN ARCR PROCEDURE, AN E4 ERROR WAS DISPLAYED WHEN USING THE COAGULATION WAND. THE CUSTOMER COULD NOT CONFIRM ANY SMOKE, SPARKS OR OVERHEATING WHEN E4 ERROR OCCURRED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A SMITH AND NEPHEW BACK-UP DEVICE. NO PATIENT INJURIES, DELAYS OR 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 11612922 ↗
• InjuryMar 25, 2021Protective Measures Problem; Protective Measures Problem

  IT WAS REPORTED THAT DURING PCL AVULSION SURGERY, THE AMBIENT SUPER MULTIVAC 50 WAND SHOWED E8 ERROR CODE AND THEY COULD NOT PROCEED. THERE WAS A SURGICAL DELAY GREATER THAN 30 MINUTES AND THERE WAS A CHANGE IN SURGICAL TECHNIQUE. 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 11572596 ↗
• InjuryMar 25, 2021Protective Measures Problem; Protective Measures Problem

  IT WAS REPORTED THAT DURING PCL AVULSION SURGERY, THE AMBIENT SUPER MULTIVAC 50 WAND SHOWED E8 ERROR CODE AND THEY COULD NOT PROCEED. THERE WAS A SURGICAL DELAY GREATER THAN 30 MINUTES AND THERE WAS A CHANGE IN SURGICAL TECHNIQUE. 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 11572594 ↗
• InjuryMar 25, 2021Protective Measures Problem; Protective Measures Problem

  IT WAS REPORTED THAT DURING A MULTI LIGAMENT RECONSTRUCTION, 3 AMBIENT SUPER MULTIVAC 50 IFS DEVICES FAILED WITH E3 AND E7 ERROR ON THE SCREEN. SAME THING HAPPENED WHEN THE CONSOLE WAS SWITCHED. THE ACTIVATION OF THE DEVICES WAS 5 MINS ONLY. THE PROCEDURE WAS FINISHED WITH A BACKUP DEVICE (MEGAVAC 90). A DELAY OF 30 MINUTES OR LESS WAS REPORTED AND THERE WERE NO PATIENT COMPLICATIONS. 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 11567762 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K083306, K180848. One submission often covers many models, so check the product and lot details in each record.

• Z-0579-2015 · Oct 27, 2014 · Terminated
  Model Number ASHA4730-01: Ambient HipVac 50 Wand with Integrated Finger Switches and Model Number ASHA5050-01: Ambient KVac Wand with Integrated Finger Switches. The Wands are ind