Coblation ASCA5001-01Recalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 00817470001761), received between Feb 15, 2018 and Jul 8, 2024 — classified as 19 malfunctions.

The most frequently reported specific device problem is “Material Separation” (3 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. 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 19 most recent of 19 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 8, 2024Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  IT WAS REPORTED THAT DURING AN UNSPECIFIED PROCEDURE, THE AMBIENT MEGAVAC WAND WAS DISPLAYING AN ¨7 ERROR¨ MESSAGE WHEN CONNECTED TO THE TERMINAL. 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 19697586 ↗
• MalfunctionMay 24, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, A SMALL PIECE OF THE BLACK PLASTIC ON THE SHAFT CAME OFF THE AMBIENT MEGAVAC WAND, IT WAS RETRIEVED FROM THE PATIENT'S JOINT. THE PROCEDURE WAS COMPLETED WITHOUT SURGICAL DELAY USING THE SAME DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19396686 ↗
• MalfunctionFeb 20, 2024Self-Activation or Keying; Electrical Shorting; Self-Activation or Keying; Electrical Shorting

  IT WAS REPORTED THAT, WHEN THE AMBIENT MEGAVAC 90 WAS PLUGGED TO THE BYPASS BOX FOR USE, THE ACTIVATE SOUND STARTED AND A LIGHT FOR THE "COAG" LIT UP, WITHOUT BEING ACTIVATED WITH THE FOOT PEDAL, INDICATING A SHORT. THE DEFICIENCY WAS OBSERVED WHILE PERFORMING THE INVESTIGATION FOR THE DEVICE; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18741898 ↗
• MalfunctionAug 15, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT, DURING A KNEE PROCEDURE, TWO (2) AMBIENT MEGAVAC WANDS HAD A VAPORIZER FAILURE. SURGERY WAS COMPLETED AFTER A DELAY GREATER THAN 30 MINUTES USING A BACK-UP DEVICE INSTEAD. NO FURTHER COMPLICATIONS WERE REPORTED. PATIENT'S STATUS IS OKAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17551023 ↗
• MalfunctionApr 6, 2021Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT THE WAND WAS OVERHEATING. NO CASE WAS INVOLVED. 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 11618852 ↗
• MalfunctionDec 28, 2020Protective Measures Problem; Protective Measures Problem

  IT WAS REPORTED THAT DURING THE SET UP BEFORE THE SURGERY THERE WAS AN ERROR CODE E6 WHEN THE WAND WAS CONNECTED AND SYSTEM GENERATED AN ALARM NOISE. NO PATIENT INJURIES OR DELAY REPORTED. SMITH AND NEPHEW BACK-UP DEVICE WAS AVAILABLE TO COMPLETE THE SURGERY. 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 11083966 ↗
• MalfunctionJun 5, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE AMBIENT MEGAVAC HAD A E7 ERROR CODE. THE INCIDENT OCCURRED BEFORE THE PROCEDURE; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Patient Involvement

  MAUDE report 10124064 ↗
• MalfunctionMay 14, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT DURING A KNEE SURGERY THE AMBIENT MEGA VAC SCREEN SHOWS AN ERROR E7 WHEN THE WAND WAS CONNECTED TO THE QUANTUM. THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING A BACK-UP DEVICE, A DELAY OF FEWER THAN 5 MINUTES WAS REPORTED. NO PATIENT INJURY 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 10058231 ↗
• MalfunctionMar 26, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT, DURING A PROCEDURE, THE AMBIENT MEGAVAC 90 HAD AN UNSPECIFIED FUNCTIONAL FAILURE. ALL PIECES WERE REMOVED FROM WITHIN THE PATIENT. THERE WAS A BACKUP DEVICE AVAILABLE. A DELAY WAS REPORTED; HOWEVER, THE EXTENT OF SAID DELAY IS UNKNOWN. NO PATIENT INJURY WAS 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 9887046 ↗
• MalfunctionMar 2, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT DURING SHOULDER ARTHROSCOPY PROCEDURE THE DISTAL END OF THE DEVICE DETACHED SPONTANEOUSLY. THE DEVICE BROKE IN THE PATIENT BUT THE ENDS REMAINED ATTACHED TO THE DEVICE SO THERE WAS NO PIECE TO REMOVE FROM THE PATIENT. NO DELAY AND A BACK UP WAS AVAILABLE TO COMPLETE THE PROCEDURE. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9773038 ↗
• MalfunctionFeb 11, 2019Temperature Problem

  IT WAS REPORTED THAT DURING A SHOULDER PROCEDURE THE DEVICE WAS HEATING UP. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT DELAY USING A BACK-UP DEVICE. NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8327762 ↗
• MalfunctionDec 24, 2018Failure to Power Up

  IT WAS REPORTED THAT, DURING A SHOULDER ARTHROSCOPY, THE ARTHROWAND FAILED TO WORK WHEN PLUGGED IN TO CONSOLE. THE PROCEDURE WAS COMPLETE WITH VAPR FROM DEPUY SYNTHES. THERE WAS NEITHER SIGNIFICANT DELAY NOR PATIENT INJURIES.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8194425 ↗
• MalfunctionDec 24, 2018Failure to Power Up

  IT WAS REPORTED THAT THE ARTHROW AND FAILED TO WORK WHEN PLUGGED IN TO CONSOLE DURING A SHOULDER PROCEDURE. THE PROCEDURE WAS COMPLETE WITH VAPR FROM DEPUY SYNTHES. THERE WAS NO SIGNIFICANT DELAY OR PATIENT INJURIES.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8194424 ↗
• MalfunctionSep 4, 2018Physical Resistance/Sticking

  IT WAS REPORTED THAT THE DEVICE GOT STUCK ON THE ON POSITION. NO PATIENT INJURY WAS REPORTED. THE DEVICE CONTINUOUSLY RUN.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7843627 ↗
• MalfunctionAug 22, 2018Detachment of Device or Device Component

  IT WAS REPORTED THAT THE HEAD JUST CAME OFF THE RF NEARING THE END OF THE PROCEDURE, NO INJURY WAS CAUSED. A BACKUP DEVICE WAS AVAILABLE TO COMPLETE THE PROCEDURE WITH NO PATIENT INJURIES.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7805413 ↗
• MalfunctionAug 22, 2018Electrical Shorting

  IT WAS REPORTED THAT THE DEVICE DOES NOT WORK AND CAUSES SHORT CIRCUIT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7805403 ↗
• MalfunctionMay 22, 2018Device Inoperable; Device Displays Incorrect Message

  IT WAS REPORTED THAT DEVICE DID NOT WORK, WHEN IT WAS CONNECTED IT DISPLAYED AN ERROR E7. THERE WAS A SIGNIFICANT DELAY GREATER THAN 30 MINUTES AND A BACKUP DEVICE WAS AVAILABLE TO COMPLETE THE PROCEDURE WITH NO PATIENT INJURIES.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7534659 ↗
• MalfunctionMay 7, 2018Detachment Of Device Component

  IT WAS REPORTED THAT THE WAND WAS PUT UNDER NO MORE STRESS THAN NORMAL AND PART OF THE ELECTRODE POPPED OFF.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7492780 ↗
• MalfunctionFeb 15, 2018Break

  IT WAS REPORTED THAT A PIECE OF THE DEVICE CHIPPED OFF AND FALL INSIDE THE PATIENT. THE PIECE WAS RETRIEVED. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7275552 ↗