Harmonic ACE HAR36Recalls & reported problems
Ethicon Endo-Surgery, LLC · Harmonic Ace 5mm Diameter Shears 36cm Shaft length + Adaptive Tissue Technology for use with Generator G11 · Class U
Quick summary
This Harmonic ACE ultrasonic surgical shears is a surgical instrument used during operations. Its 2,740 reports mostly describe parts separating or detaching, the instrument failing to read its input signal, and parts breaking. The reports include no deaths and 45 injuries, and most list no clinical signs for the patient. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 2,726
- Deaths reported
- 0
- Injuries reported
- 41
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2,726 adverse event reports that list this exact device (DI 10705036014447), received between Jun 18, 2015 and Sep 29, 2026 — classified as 41 injuries, 2,685 malfunctions.
The most frequently reported specific device problem is “Material Separation” (636 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.
Reports received per month
Most reported problems
Device problems
- Material Separation636
- Failure to Read Input Signal475
- Detachment of Device or Device Component343
- Break279
- Activation Problem124
- Inappropriate or Unexpected Reset120
- Device Displays Incorrect Message112
- Difficult or Delayed Activation104
Patient problems
- No Clinical Signs, Symptoms or Conditions1,757
- No Consequences Or Impact To Patient937
- No Code Available17
- Hemorrhage/Blood Loss/Bleeding14
- Blood Loss10
- Insufficient Information4
- Abdominal Pain2
- Foreign Body In Patient2
Recent adverse event reports
The 25 most recent of 2,726 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 29, 2026Activation Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50934273 ↗MalfunctionSep 28, 2026Failure to Read Input Signal
It was reported that during an unknown procedure the device shows multiple errors "replace instruments" and "identifying device". Completed the procedure with the help of another device. No patient consequences reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50916665 ↗MalfunctionSep 28, 2026Material Separation
It was reported that during a Proctrectomy procedure the titanium tip broke off. The broken piece was retrieved by forceps and was discarded. Changed to another device to complete surgery. There was no patient consequence reported. No additional information can be provided.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50913603 ↗MalfunctionSep 22, 2026Failure to Read Input Signal
It was reported that during an unknown procedure while using the device it showed multiple errors like replace instruments , identifying device etc. Used the another device to complete the procedure. No patient consequences reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50854349 ↗MalfunctionSep 18, 2026Mechanical Problem; Material Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50828741 ↗MalfunctionSep 17, 2026Difficult or Delayed Activation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50809155 ↗MalfunctionSep 17, 2026Difficult or Delayed Activation
It was reported that during a liver resection procedure the device could not be activated. Changed to another device to complete surgery. There was no patient consequence reported. No additional information can be provided.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50803938 ↗MalfunctionSep 17, 2026Detachment of Device or Device Component
It was reported that during an unknown procedure the device came loose in the jaw area. No patient consequences reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50802635 ↗MalfunctionSep 15, 2026Detachment of Device or Device Component
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50779091 ↗MalfunctionSep 14, 2026Material Separation; Failure to Read Input Signal; Inappropriate or Unexpected Reset
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50763031 ↗MalfunctionSep 14, 2026Excessive Heating
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50761678 ↗MalfunctionAug 31, 2026Material Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50529694 ↗MalfunctionAug 21, 2026Detachment of Device or Device Component; Material Integrity Problem
It was reported that during an unknown procedure and activation of the device, the silicone or Teflon came loose from the forceps, right at the beginning of the procedure. Forceps needed to be replaced and the procedure proceeded without delay or complication to the patient.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50373172 ↗MalfunctionJun 25, 2026Material Integrity Problem
IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE WHITE PAD STARTED TO MELT AND TORE OFF. SO THERE WAS A DELAY IN THE SETTING UP OF THE NEW PROBE. NO PATIENT CONSEQUENCES REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25620023 ↗MalfunctionJun 24, 2026Difficult or Delayed Activation
IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THE FORCEPS STOPPED WORKING AT THE START OF THE SURGERY. THE CABLE AND THE GENERATOR WERE REPLACED, BUT IT DID NOT START WORKING AGAIN. NO PATIENT CONSEQUENCES REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25610786 ↗MalfunctionJun 15, 2026Difficult or Delayed Activation
IT WAS REPORTED THAT AFTER AN UNKNOWN PROCEDURE THE DEVICE WAS NOT WORKING. NO CONSEQUENCES TO PATIENTS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25510527 ↗MalfunctionJun 12, 2026Failure to Read Input Signal
IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THE OR TEAM IS COMPLAINING ABOUT AN ULTRACISION HANDPIECE WITH THE ERROR MESSAGE "TWO BUTTON ACTIVATION." THERE WERE NO PATIENT CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25491417 ↗MalfunctionJun 12, 2026Material Separation
IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THE ACTIVE BLADE OF DEVICE BROKEN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25491276 ↗MalfunctionJun 9, 2026Difficult or Delayed Activation
IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THE PHYSICIAN REPORTED THAT AFTER SEVERAL MINUTES OF PROCEDURE THE DEVICE STOP WORKING. NO CONSEQUENCES FOR THE PATIENT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25445116 ↗MalfunctionJun 8, 2026Difficult or Delayed Activation
IT WAS REPORTED THAT THE FORCEPS STOPPED WORKING DURING THE UNKNOWN SURGERY AND IT WAS NECESSARY TO USE ANOTHER DEVICE TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25435898 ↗MalfunctionJun 1, 2026Activation Problem
IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THERE WAS A PROBLEM WITH THE DEVICE. THE MAX BUTTON DIDN'T WORK. NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25351543 ↗MalfunctionMay 26, 2026Material Separation; Failure to Read Input Signal
IT WAS REPORTED THAT AT THE VERY BEGINNING OF THE UNKNOWN SURGERY, THE DOCTOR ATTEMPTED TO USE THE DEVICE AND OBSERVED AN ERROR ON THE GENERATOR. ALL INITIAL TESTS WERE REPEATED, BUT THE DEVICE DID NOT FUNCTION. SHORTLY THEREAFTER, THE FORCEPS WERE REMOVED FROM THE TROCAR, AND IT WAS NOTED THAT THE TIP WAS BROKEN. ANOTHER FORCEPS FROM THE SAME LOT WAS OPENED, AND THE SURGERY WAS PERFORMED NORMALLY UNTIL COMPLETION, WITH NO FURTHER ISSUES WITH THE FORCEPS OR THE GENERATOR. THERE WERE NO PATIENT CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25279822 ↗MalfunctionMay 26, 2026Failure to Read Input Signal; Difficult or Delayed Activation
IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THE FORCEPS WERE NOT COAGULATING. OUR AT WAS IN THE ROOM FOLLOWING UP, INFORMED THAT THE TWEEZERS BEGAN TO ASK FOR TESTING, SHE CHANGED THE HANDPIECE, AND HAD NO SOLUTION BUT TO CHANGE THE TWEEZERS. THERE WERE NO PATIENT CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25279583 ↗MalfunctionMay 20, 2026Failure to Read Input Signal
IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THE "RESTART GEN11" ERROR MESSAGE IS COMING. AFTER RESTART GEN11, ERROR MESSAGE IS STILL COMING. THERE WERE NO PATIENT CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25232985 ↗MalfunctionMay 18, 2026Mechanical Problem
IT WAS REPORTED THAT DURING A TLH THE PROBE NOT WORKING. THE CLOSING HANDLE IS STUCK.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25211587 ↗
Other Instrument, ultrasonic surgical devices
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- Harmonic HARHD36Ethicon Endo-Surgery, LLC · Instrument, ultrasonic surgical1 recall2 deaths5,037 reports
- Harmonic HAR1136Ethicon Endo-Surgery, LLC · Instrument, ultrasonic surgical2 deaths1,538 reports
- THUNDERBEAT 5 mm,35 cm, Front-actuated Grip Type S TB-0535FCSOlympus Medical Systems Corp. · Instrument, ultrasonic surgical3 recalls1,373 reports
- THUNDERBEAT 5 mm,35 cm,Front-actuated Grip Type S TB-0535FCSOlympus Medical Systems Corp. · Instrument, ultrasonic surgical3 recalls2 deaths1,128 reports
- THUNDERBEAT 5 mm,35 cm,Front-actuated Grip Type S TB-0535FCSOlympus Medical Systems Corp. · Instrument, ultrasonic surgical2 recalls1 death970 reports
- Harmonic ACE HARH23Ethicon Endo-Surgery, LLC · Instrument, ultrasonic surgical935 reports
- Harmonic Ace ACE36EEthicon Endo-Surgery, LLC · Instrument, ultrasonic surgical860 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.