Harmonic ACE HARH23Recalls & reported problems
Ethicon Endo-Surgery, LLC · Harmonic ACE +7 Shears Advanced Hemostasis 5mm Diameter 23cm Shaft length For Use With Gray Hand Piece Only · Class U
Quick summary
This Ethicon Harmonic ACE is an ultrasonic surgical tool. The 950 reports mostly describe parts separating or detaching, the tool failing to read its input signal, and delayed activation, and several note another device was used to finish the surgery. The reports include no deaths and 6 injuries, and no recalls name this device. Reports fell to 94 over the last year from 176 in the year before.
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
- 935
- Deaths reported
- 0
- Injuries reported
- 6
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 935 adverse event reports that list this exact device (DI 10705036014676), received between Nov 30, 2017 and Sep 30, 2026 — classified as 6 injuries, 929 malfunctions.
The most frequently reported specific device problem is “Material Separation” (309 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 Separation309
- Detachment of Device or Device Component160
- Failure to Read Input Signal152
- Difficult or Delayed Activation74
- Delivered as Unsterile Product48
- Material Integrity Problem46
- Break37
- Activation, Positioning or Separation Problem26
Patient problems
- No Clinical Signs, Symptoms or Conditions766
- No Consequences Or Impact To Patient168
- Hemorrhage/Blood Loss/Bleeding4
- Insufficient Information1
- Laceration(s)1
- Low Blood Pressure/ Hypotension1
- Pneumothorax1
- Tachycardia1
Recent adverse event reports
The 25 most recent of 935 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 50949903 ↗MalfunctionSep 28, 2026Failure to Read Input Signal; Difficult or Delayed Activation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50918251 ↗MalfunctionSep 28, 2026Failure to Read Input Signal; Difficult or Delayed Activation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50917592 ↗MalfunctionSep 24, 2026Difficult or Delayed Activation
It was reported that during an unknown 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 50885372 ↗MalfunctionSep 17, 2026Activation, Positioning or Separation Problem
It was reported that during an unknown procedure the scalpel was hard to cut. 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 50804911 ↗MalfunctionSep 16, 2026Failure to Read Input Signal
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50787043 ↗MalfunctionAug 28, 2026Material Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50495914 ↗MalfunctionAug 19, 2026Material Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50326371 ↗MalfunctionJun 30, 2026Failure to Read Input Signal
IT WAS REPORTED THAT DURING A PANCREAS PROCEDURE THE UNKNOWN ALERT SCREEN 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 25667227 ↗MalfunctionJun 15, 2026Material Separation
IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE 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 25510666 ↗MalfunctionJun 12, 2026Material Separation
IT WAS REPORTED THAT DURING A LAP SPLENECTOMY 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 25484762 ↗InjuryJun 10, 2026Difficult or Delayed Activation; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT DURING THE UNKNOWN SURGERY, THE BLADE STOPPED WORKING SUDDENLY, WITH NO POWER OUTPUT. TRIED TO RECONNECT AND CHANGE THE HP, THE BLADE STILL DID NOT WORK. DURING THE EVENT, THE PATIENT EXPERIENCED BLEEDING, BLOOD PRESSURE DECREASING, AND HEART RATE INCREASING. FINALLY, CHANGED A NEW DEVICE TO CONTINUE THE OPERATION. THE SURGERY WAS DELAYED ABOUT 1 HOUR.
Patient problems: Hemorrhage/Blood Loss/Bleeding; Low Blood Pressure/ Hypotension; Tachycardia
MAUDE report 25462148 ↗MalfunctionJun 5, 2026Difficult or Delayed Activation
IT WAS REPORTED THAT DURING AN UNKNOWN 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 25407669 ↗MalfunctionJun 1, 2026Difficult or Delayed Activation
IT WAS REPORTED THAT DURING A RADICAL THYROIDECTOMY 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 25354068 ↗MalfunctionMay 28, 2026Material Separation
IT WAS REPORTED THAT DURING A RADICAL ENDOMETRIAL CANCER SURGERY 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 25322304 ↗MalfunctionMay 26, 2026Failure to Read Input Signal
IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THE ¿REMOVE DEVICE FROM PATIENT¿ ALERT SCREEN WAS DISPLAYED BY THE GENERATOR. CHANGED TO ANOTHER DEVICE TO COMPLETE SURGERY. THERE WAS NO PATIENT CONSEQUENCE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25294911 ↗MalfunctionMay 21, 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 25243125 ↗MalfunctionMay 21, 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 25242986 ↗MalfunctionMay 15, 2026Activation, Positioning or Separation Problem
IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THE SCALPEL WAS HARD TO CUT. 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 25185444 ↗MalfunctionMay 11, 2026Material Separation
IT WAS REPORTED THAT DURING A PARTIAL LIVER RESECTION 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 25140997 ↗MalfunctionMay 11, 2026Failure to Read Input Signal
IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE 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 25136669 ↗MalfunctionMay 11, 2026Failure to Read Input Signal
IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THE ¿RELAX PRESSURE ON BLADE¿ ALERT SCREEN 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 25136645 ↗MalfunctionMay 6, 2026Failure to Read Input Signal
IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE 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 25104442 ↗MalfunctionMay 6, 2026Delivered as Unsterile Product
IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THE PACKAGE WAS FOUND DAMAGED BEFORE USING 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 25103442 ↗MalfunctionMay 5, 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 25086676 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.