Harmonic ACE HARH36Recalls & reported problems
Ethicon Endo-Surgery, LLC · Harmonic ACE +7 Laparoscopic Shears Advanced Hemostasis 5mm Diameter 36cm Shaft length For Use With Gray Hand Piece Only · Class U
Quick summary
This Harmonic ACE laparoscopic shears is an ultrasonic surgical instrument. Reports mostly describe parts separating or breaking off during use, the instrument failing to read input signals, components detaching, and delayed activation. There are 7,678 reports, including 4 deaths and 54 injuries. No recalls name this device. Reports fell to 718 in the last 12 months from 1,096 in the 12 months 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
- 7,609
- Deaths reported
- 4
- Injuries reported
- 55
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 7,609 adverse event reports that list this exact device (DI 10705036014621), received between Nov 20, 2017 and Sep 30, 2026 — classified as 4 deaths, 55 injuries, 7,550 malfunctions.
The most frequently reported specific device problem is “Material Separation” (2,392 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 Separation2,392
- Failure to Read Input Signal1,412
- Detachment of Device or Device Component1,365
- Difficult or Delayed Activation491
- Material Integrity Problem379
- Break357
- Activation, Positioning or Separation Problem269
- Inappropriate or Unexpected Reset221
Patient problems
- No Clinical Signs, Symptoms or Conditions6,045
- No Consequences Or Impact To Patient1,521
- No Code Available23
- Hemorrhage/Blood Loss/Bleeding12
- Blood Loss10
- Foreign Body In Patient8
- Burn(s)7
- Insufficient Information7
Recent adverse event reports
The 25 most recent of 7,609 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 2026Failure to Read Input Signal; Difficult or Delayed Activation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50947839 ↗MalfunctionSep 29, 2026Material Separation
It was reported that during a Liver Resection 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 50935635 ↗MalfunctionSep 29, 2026Smoking; Material Integrity Problem
It was reported that during an unknown procedure there was lots of smoke found. Then the tissue pad melted. 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 50931148 ↗MalfunctionSep 28, 2026Activation, Positioning or Separation Problem
It was reported that during a Lobectomy 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 50923256 ↗MalfunctionSep 28, 2026Material Separation
It was reported that during a Hepatectomy 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 50923218 ↗MalfunctionSep 28, 2026Material Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50923038 ↗MalfunctionSep 28, 2026Material Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50922336 ↗MalfunctionSep 28, 2026Material Separation
It was reported that during an unknown event the titanium tip broke off. The broken piece was retrieved by forceps and was discarded. Changed another one to complete surgery. No additional information can be provided.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50921765 ↗MalfunctionSep 28, 2026Material Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50919356 ↗MalfunctionSep 28, 2026Difficult or Delayed Activation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50917315 ↗MalfunctionSep 24, 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 complete surgery. No additional information can be provided.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50889307 ↗MalfunctionSep 24, 2026Material Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50886514 ↗MalfunctionSep 24, 2026Activation, Positioning or Separation Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50885040 ↗MalfunctionSep 24, 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 50884961 ↗MalfunctionSep 24, 2026Failure to Read Input Signal
It was reported that during an unknown 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 50884582 ↗MalfunctionSep 24, 2026Material Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50884258 ↗MalfunctionSep 24, 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 50883992 ↗MalfunctionSep 24, 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 50883842 ↗MalfunctionSep 23, 2026Material Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50873374 ↗MalfunctionSep 23, 2026Failure to Read Input Signal; Difficult or Delayed Activation
It was reported that during an unknown procedure the ¿Replace Instrument¿ alert screen is displayed. And then 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 50873083 ↗MalfunctionSep 23, 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 complete surgery. There was no patient consequence reported. No additional information can be provided.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50872947 ↗MalfunctionSep 23, 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 50872479 ↗MalfunctionSep 23, 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 50870828 ↗MalfunctionSep 23, 2026Material Integrity Problem
It was reported that during an unknown procedure the white tissue pad was partially detached. The fallen piece was retrieved by forceps and was disposed of. 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 50869723 ↗MalfunctionSep 23, 2026Failure to Read Input Signal
It was reported that during an unknown procedure 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 50869100 ↗
Other Instrument, ultrasonic surgical devices
- Harmonic HARHD36Ethicon Endo-Surgery, LLC · Instrument, ultrasonic surgical1 recall2 deaths5,037 reports
- 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
- 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.