None 400272Recalls & reported problems

Summary

The FDA's MAUDE database contains 224 adverse event reports that list this exact device (DI 00886874111086), received between Feb 13, 2018 and Aug 4, 2026 — classified as 83 injuries, 141 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (125 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 224 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 4, 2026No Device Output

  It was reported that during a da Vinci-assisted surgical procedure, the 8mm Harmonic ACE instrument cannot be recognized.The procedure was completed with no reported injury.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50125306 ↗
• MalfunctionMay 6, 2026No Device Output

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE HARMONIC ACE INSERT INSTRUMENT COULD NOT BE RECOGNIZED. THE PROCEDURE WAS COMPLETED WITH NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25105794 ↗
• MalfunctionMay 6, 2026No Device Output

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE HARMONIC ACE INSERT INSTRUMENT COULD NOT BE RECOGNIZED. THE PROCEDURE WAS COMPLETED WITH NO PATIENT HARM. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE SITE TO OBTAIN ADDITIONAL INFORMATION, HOWEVER, NO FURTHER DETAILS COULD BE PROVIDED REGARDING THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25105270 ↗
• MalfunctionMay 6, 2026Output Problem

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE HARMONIC ACE INSTRUMENT COULD NOT BE USED DURING THE OPERATION. THE PROCEDURE WAS COMPLETED WITH NO PATIENT HARM. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE INSTRUMENT COULD NOT MOVE SUDDENLY. IT WAS CHANGED TO ANOTHER INSTRUMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25105266 ↗
• MalfunctionMay 6, 2026Output Problem

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE HARMONIC ACE INSTRUMENT COULD NOT BE USED DURING THE OPERATION. THE PROCEDURE WAS COMPLETED WITH NO PATIENT HARM. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE INSTRUMENT SHOWED ¿REDUCE THE PRESSURE OF THE BLADE OF THE INSTRUMENT¿ ERROR. IT WAS CHANGED ANOTHER INSTRUMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25105265 ↗
• MalfunctionFeb 25, 2026Break

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE HARMONIC ACE HAD BROKEN TIP. THERE WAS NO ALLEGATION OF FRAGMENT FALLEN INSIDE THE PATIENT. THE CUSTOMER USED A BACKUP INSTRUMENT OF THE SAME KIND TO CONTINUE. THE PROCEDURE WAS COMPLETING AS PLANNED WITH NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24450292 ↗
• MalfunctionFeb 25, 2026Break

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE SURGEON FOUND THE HARMONIC BLADE INSERT TO BE BROKEN. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) MADE MULTIPLE FOLLOW UP ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION, HOWEVER, NO FURTHER DETAILS HAVE BEEN RECEIVED AS OF DATE OF THIS REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24450257 ↗
• MalfunctionFeb 25, 2026Break

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED THYROIDECTOMY SURGICAL PROCEDURE, A "RELIEVE THE PRESSURE ON THE KNIFE HEAD" MESSAGE DISPLAYED WHILE THE CUSTOMER WAS USING THE HARMONIC ACE CURVED SHEARS INSERT TO DISSOCIATE THE TISSUE. A BACKUP INSTRUMENT OF SAME KIND WAS USED TO CONTINUE THE PROCEDURE. THERE WAS NO REPORT OF FRAGMENT(S) FALLING INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITH NO REPORT OF PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24450231 ↗
• MalfunctionFeb 25, 2026Break

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE HARMONIC ACE INSTRUMENT WAS DAMAGED AND BECAME UNUSABLE. TROUBLESHOOTING WAS PERFORMED BY REPLACING THE INSTRUMENT TO THE BACKUP AND THIS RESOLVED THE ISSUE. FOLLOWING THIS, THE USER CONTINUED THE PROCEDURE WITH NO FURTHER ISSUE REPORTED. NO FRAGMENT FELL INTO THE PATIENT. NO KNOWN IMPACT OR PATIENT CONSEQUENCE WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24450223 ↗
• MalfunctionFeb 25, 2026Break

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED PROSTATECTOMY SURGICAL PROCEDURE, THE HARMONIC ACE BROKE AT THE JAW DURING USE. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24450215 ↗
• MalfunctionFeb 25, 2026Break; No Device Output

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED ESOPHAGECTOMY PROCEDURE, THE HARMONIC ACE INSTRUMENT PASSED RECOGNITION; HOWEVER, THE INSTRUMENT WAS NON-RESPONSIVE WHEN THE SURGEON ATTEMPTED TO CONTROL THE INSTRUMENT. FOLLOWING THIS, A RECOGNITION ERROR WAS DISPLAYED. TROUBLESHOOTING WAS PERFORMED BY REMOVING THE INSTRUMENT, REASSEMBLING THE HARMONIC HANDPIECE AND THE INSTRUMENT CABLE, AND RETESTING THE INSTRUMENT; HOWEVER, RECOGNITION ERROR PERSISTED. THE USER COMPLETED THE PROCEDURE USING THE BACKUP INSTRUMENT WITH NO FURTHER ISSUE REPORTED. NO FRAGMENT FELL INSIDE THE PATIENT. NO KNOWN IMPACT OR PATIENT CONSEQUENCE WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24450214 ↗
• MalfunctionFeb 17, 2026Break

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE HARMONIC ACE INSTRUMENT HAD A CRACKED BLADE. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24371160 ↗
• MalfunctionFeb 11, 2026Break

  REFER TO H11 FOR FOLLOW-UP INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24311136 ↗
• InjuryJan 27, 2026Detachment of Device or Device Component

  REFER TO H11 FOR FOLLOW-UP INFORMATION.

  Patient problems: Foreign Body In Patient

  MAUDE report 24188374 ↗
• MalfunctionJan 23, 2026No Device Output

  IT WAS REPORTED THAT THE CUSTOMER EXPERIENCED AN ISSUE WITH AN INTUITIVE PRODUCT. THE CUSTOMER REPORTED EVENT HAS NO REPORT OF PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24170867 ↗
• MalfunctionJan 7, 2026No Device Output

  IT WAS REPORTED THAT THE CUSTOMER EXPERIENCED AN ISSUE WITH AN INTUITIVE PRODUCT. THE CUSTOMER REPORTED EVENT HAS NO REPORT OF PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23987052 ↗
• MalfunctionJan 5, 2026No Device Output

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE HARMONIC ACE INSTRUMENT COULD NOT BE RECOGNIZED. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23969350 ↗
• MalfunctionDec 9, 2025Break; Break

  IT WAS REPORTED THAT DURING DA VINCI-ASSISTED SURGICAL PROCEDURE, THE HARMONIC ACE INSTRUMENT'S BLADE BROKE. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: DURING A DISSECTING TASK, A BLADE ON AN INSTRUMENT BROKE. THE BROKEN PART COMPLETELY DETACHED FROM THE INSTRUMENT, BUT NO FRAGMENTS FELL INTO THE PATIENT. THE INSTRUMENT WAS INSPECTED PRIOR TO USE. THE SURGEON REPORTED NO PRIOR ISSUES WITH THE FUNCTIONALITY OF THE INSTRUMENT DURING THE SURGICAL PROCEDURE AND STATED THAT THE INSTRUMENT DID NOT COLLIDE WITH ANY OTHER HARD MATERIAL OR INSTRUMENTS. THE SURGEON DOES NOT KNOW WHAT CAUSED THE INSTRUMENT TO BREAK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23761936 ↗
• InjuryDec 8, 2025Break; Break

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE BLADE OF THE HARMONIC ACE INSTRUMENT FRACTURED AND A FRAGMENT FELL INSIDE THE PATIENT. THERE WERE NO INSTRUMENT COLLISIONS DURING THE CASE. THE FRACTURED FRAGMENT WAS REMOVED DURING THE SAME SURGICAL PROCEDURE WHICH WAS COMPLETED ROBOTICALLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23744910 ↗
• MalfunctionNov 25, 2025No Apparent Adverse Event; No Apparent Adverse Event

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE HARMONIC ACE INSERT WAS NOT WORKING. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23641348 ↗
• MalfunctionNov 22, 2025No Device Output; No Device Output

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE HARMONIC ACE INSERT ACCESSORY COULD NOT BE RECOGNIZED BY THE SYSTEM. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23625063 ↗
• MalfunctionNov 19, 2025No Device Output; No Device Output

  IT WAS REPORTED THAT PRIOR TO THE START OF A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE HARMONIC ACE INSERT ACCESSORY WAS OBSERVED TO HAVE A RECOGNITION ISSUE. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23590743 ↗
• MalfunctionNov 7, 2025Break; Break

  IT WAS REPORTED THAT DURING DA VINCI-ASSISTED SURGICAL PROCEDURE, WHEN SEPARATING THE TISSUE, THE HEAD END OF THE HARMONIC ACE INSTRUMENT SUDDENLY BROKE. NO FRAGMENT FELL INTO THE PATIENT. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. ISI FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE BROKEN PART OF TIP COMPLETELY DETACH FROM THE INSTRUMENT. NO FRAGMENT FELL INTO THE PATIENT. THE INSTRUMENT WAS INSPECTED PRIOR TO USE WITH NO NOTED DAMAGE. DISSECTING WAS BEING PERFORMED WHEN THE ISSUE OCCURRED. PER SURGEON, THE ISSUE IS RELATED TO INSTRUMENT QUALITY. THE INSTRUMENT WAS IN USE FOR ABOUT 30 MINUTES PRIOR TO THE ISSUE. NO ISSUE WAS NOTED WITH THE FUNCTIONALITY OF THE INSTRUMENT DURING THE SURGICAL PROCEDURE. THERE IS NO REPORT OF ANY COLLISION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23502998 ↗
• MalfunctionNov 3, 2025Break; Break

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE HARMONIC ACE INSERT ACCESSORY'S BLADE WAS BROKEN. THE USER COMPLETED THE PROCEDURE USING A BACKUP HARMONIC ACE INSTRUMENT WITH NO FURTHER ISSUE REPORTED. NO FRAGMENT FELL INSIDE THE PATIENT. NO KNOWN IMPACT OR PATIENT CONSEQUENCE WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23448026 ↗
• MalfunctionOct 24, 2025No Device Output; No Device Output

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, HARMONIC ACE INSERT WAS NOT RECOGNIZED BY THE SYSTEM. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23376514 ↗