Harmonic ACE HARH45Recalls & reported problems
Ethicon Endo-Surgery, LLC · Harmonic ACE +7 Laparoscopic Shears Advanced Hemostasis 5mm Diameter 45cm Shaft length For Use With Gray Hand Piece Only · Class U
Data updated Oct 13, 2026 from official FDA records · Editorial policy
Quick summary
This Ethicon Harmonic ACE ultrasonic surgical shears are used to cut and seal tissue during laparoscopic surgery. Its 335 reports mostly describe parts separating or detaching, the generator failing to read the instrument, and alert messages that led staff to switch to another device mid-surgery. The reports mention 14 injuries and no deaths. 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
- 335
- Deaths reported
- 0
- Injuries reported
- 14
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 335 adverse event reports that list this exact device (DI 10705036014638), received between Dec 7, 2017 and Sep 30, 2026 — classified as 14 injuries, 321 malfunctions.
The most frequently reported specific device problem is “Material Separation” (85 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 Separation85
- Failure to Read Input Signal57
- Detachment of Device or Device Component51
- Break25
- Difficult or Delayed Activation16
- Activation, Positioning or Separation Problem14
- Material Integrity Problem14
- Delivered as Unsterile Product11
Patient problems
- No Clinical Signs, Symptoms or Conditions225
- No Consequences Or Impact To Patient96
- Blood Loss10
- Not Applicable7
- Hemorrhage/Blood Loss/Bleeding4
- Hematoma1
- Insufficient Information1
- No Code Available1
Recent adverse event reports
The 25 most recent of 335 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 2026Material Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50951194 ↗MalfunctionSep 29, 2026Activation, Positioning or Separation Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50938424 ↗MalfunctionSep 29, 2026Failure to Read Input Signal
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50934016 ↗MalfunctionSep 21, 2026Material Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50842081 ↗MalfunctionAug 28, 2026Material Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50503313 ↗MalfunctionJun 29, 2026Failure to Read Input Signal
IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THE ¿REPLACE INSTRUMENT¿ ALERT SCREEN WAS DISPLAYED. CHANGED TO ANOTHER DEVICE TO CONTINUE SURGERY , STILL HAD THE SAME ISSUE . 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 25650570 ↗MalfunctionJun 24, 2026Failure to Read Input Signal
IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THE ¿TIGHTEN ASSEMBLY¿ ALERT SCREEN WAS DISPLAYED BY THE GENERATOR. 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 25610124 ↗MalfunctionJun 11, 2026Activation, Positioning or Separation Problem
IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE IT WAS HARD TO CUT THE TISSUE WITH THE SCALPEL. 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 25472877 ↗MalfunctionJun 1, 2026Material Separation
IT WAS REPORTED THAT DURING AN UNKNOWN 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 25351490 ↗MalfunctionMay 18, 2026Delivered as Unsterile Product
IT WAS REPORTED THAT DURING AN UNKNOWN SURGERY, BEFORE USED ON THE PATIENT, THE PACKAGE WAS FOUND DAMAGED. CHANGED TO ANOTHER ONE 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 25207008 ↗MalfunctionMay 6, 2026Activation, Positioning or Separation Problem
IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THE SCALPEL WAS HARD TO CUT AND COAGULATE. CHANGED TO ANOTHER DEVICE TO CONTINUE THE SURGERY. THERE WAS NO PATIENT CONSEQUENCE REPORTED. NO ADDITIONAL INFORMATION CAN BE PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25101500 ↗MalfunctionApr 29, 2026Activation, Positioning or Separation Problem; Detachment of Device or Device Component
IT WAS REPORTED THAT DURING A RYGB THE DEVICE WAS OPENED AND SET UP AS PER ODP. CONNECTED TO GREY CABLE AND TO GEN11, SYSTEM SHOWED "READY." THE DEVICE WAS PUT INTO QUIVER. WHEN PASSED TO SURGEON AND INSERTED INTO TROCAR, SURGEON NOTICED SEALING WITH GREY ENERGY BUTTON TOOK LONGER THAN USUAL. OPENED JAWS TO INSPECT AND REALIZED THE WHITE TISSUE PAD WAS NOT PRESENT. FORTUNATELY, THE WHITE TISSUE PAD WAS FOUND IN QUIVER AND NOT IN PATIENT. A NEW HARH45 WAS OPENED TO CONTINUE THE PROCEDURE. THERE WERE NO PATIENT CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25034335 ↗MalfunctionApr 17, 2026Insufficient Device Problem Information
IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THE PROBES DID NOT WORK DURING THE SURGERY. NO PATIENT WAS AFFECTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24911745 ↗MalfunctionApr 8, 2026Material Separation
IT WAS REPORTED THAT DURING VENTRAL HERNIA REPAIR PROCEDURE THE ACTIVE BLADE FELL OFF FROM THE DEVICE INTO THE PATIENT. NO PATIENT CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24816369 ↗MalfunctionMar 19, 2026Material Separation
IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THE TITANIUM TIP BROKE. 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 24638864 ↗MalfunctionMar 18, 2026Delivered as Unsterile Product
IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THE PACKAGE WAS FOUND DAMAGED BEFORE USING. 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 24626576 ↗MalfunctionMar 4, 2026Failure to Read Input Signal
IT WAS REPORTED THAT DURING A LOBECTOMY THE ¿RELAX PRESSURE ON BLADE¿ ALERT SCREEN WAS DISPLAYED BY THE GENERATOR. 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 24505717 ↗MalfunctionFeb 25, 2026Difficult or Delayed Activation
IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THE TISSUE DIDN'T CUT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24443316 ↗MalfunctionFeb 6, 2026Failure to Read Input Signal
IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THE ¿REPLACE INSTRUMENT¿ ALERT SCREEN IS DISPLAYED. 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 24279459 ↗MalfunctionFeb 6, 2026Material Separation
IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THE TITANIUM TIP BROKE. 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 24277233 ↗MalfunctionFeb 3, 2026Failure to Read Input Signal
IT WAS REPORTED THAT DURING A LYMPH NODE DISSECTION THE ¿REPLACE INSTRUMENT¿ ALERT SCREEN WAS DISPLAYED. 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 24248256 ↗MalfunctionJan 26, 2026Detachment of Device or Device Component
IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THE WHITE TISSUE PAD WAS COMPLETELY DETACHED. THE FALLEN PIECE WAS RETRIEVED BY FORCEPS AND WAS DISPOSED. 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 24183866 ↗MalfunctionJan 12, 2026Failure to Read Input Signal
IT WAS REPORTED THAT DURING A LAPAROSCOPIC LOBECTOMY THE INSTRUMENTS CANNOT BE IDENTIFIED. 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 24037173 ↗MalfunctionJan 9, 2026Failure to Read Input Signal
IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THE ¿TIGHTEN ASSEMBLY¿ ALERT SCREEN WAS DISPLAYED BY THE GENERATOR. 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 24023441 ↗MalfunctionJan 8, 2026Material Separation
IT WAS REPORTED THAT DURING A LAPAROSCOPIC LOBECTOMY THE TITANIUM TIP BROKE. 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 24004747 ↗
Other Instrument, ultrasonic surgical devices
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- Harmonic ACE HAR36Ethicon Endo-Surgery, LLC · Instrument, ultrasonic surgical2,726 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
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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