Harmonic HARHD36Recalls & reported problems
Ethicon Endo-Surgery, LLC · HARMONIC HD 1000i Shears, 36cm Shaft Length · Class U
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
Quick summary
This Ethicon Harmonic is an ultrasonic surgical instrument. Reports most often describe the device failing to read its input signal, parts separating and incorrect warnings. Some reports say it could not be activated during surgery. The device appears in 5,056 reports, including 2 deaths and 29 injuries. It has 1 open recall from July 2021 for a cracked part that can get stuck behind the energy button and may lead to burns.
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
- 5,037
- Deaths reported
- 2
- Injuries reported
- 29
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 5,037 adverse event reports that list this exact device (DI 10705036015055), received between Nov 20, 2017 and Sep 30, 2026 — classified as 2 deaths, 29 injuries, 5,006 malfunctions.
The most frequently reported specific device problem is “Failure to Read Input Signal” (1,414 reports).
1 FDA recall record name this device's identifier, 1 still open.
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
Recalls naming this device
- Jul 20, 2021Open, Classified
An internal component may be cracked and become lodged behind the energy button potentially resulting in continuous activation of the device, may result in burns
Z-2356-2021 · Root cause: Process control · FDA record ↗
Most reported problems
Device problems
- Failure to Read Input Signal1,414
- Material Separation1,132
- Detachment of Device or Device Component586
- Device Displays Incorrect Message491
- Break367
- Difficult or Delayed Activation255
- Material Integrity Problem229
- Device Alarm System119
Patient problems
- No Clinical Signs, Symptoms or Conditions3,062
- No Consequences Or Impact To Patient1,949
- No Code Available18
- Blood Loss10
- Hemorrhage/Blood Loss/Bleeding9
- No Patient Involvement9
- Insufficient Information7
- Foreign Body In Patient6
Recent adverse event reports
The 25 most recent of 5,037 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 2026Material Separation; Failure to Read Input Signal
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50950628 ↗MalfunctionSep 30, 2026Material Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50948657 ↗MalfunctionSep 30, 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 50948444 ↗MalfunctionSep 29, 2026Material Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50934847 ↗MalfunctionSep 29, 2026Activation, Positioning or Separation Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50933861 ↗MalfunctionSep 29, 2026Difficult or Delayed Activation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50932790 ↗MalfunctionSep 24, 2026Difficult or Delayed Activation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50889255 ↗MalfunctionSep 24, 2026Material Integrity Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50885559 ↗MalfunctionSep 24, 2026Material Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50883320 ↗MalfunctionSep 23, 2026Material Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50873328 ↗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 50873155 ↗MalfunctionSep 23, 2026Failure to Read Input Signal
It was reported that during a Liver Resection 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 50872787 ↗MalfunctionSep 23, 2026Failure to Read Input Signal
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50872669 ↗MalfunctionSep 23, 2026Failure to Read Input Signal
It was reported that during a Right Hemicolectomy 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 50869282 ↗MalfunctionSep 23, 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 50867511 ↗MalfunctionSep 22, 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 50857292 ↗MalfunctionSep 22, 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 50857176 ↗MalfunctionSep 22, 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 50854193 ↗MalfunctionSep 21, 2026Difficult or Delayed Activation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50842305 ↗MalfunctionSep 18, 2026Material Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50825387 ↗MalfunctionSep 18, 2026Material Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50824860 ↗MalfunctionSep 17, 2026Material Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50809843 ↗MalfunctionSep 16, 2026Material Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50793793 ↗MalfunctionSep 16, 2026Material Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50789759 ↗MalfunctionSep 15, 2026Failure to Read Input Signal
It was reported that during an unknown procedure the ¿Device error¿ alert screen displayed by the generator. And then ¿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 50772951 ↗
Other Instrument, ultrasonic surgical devices
- Harmonic ACE HARH36Ethicon Endo-Surgery, LLC · Instrument, ultrasonic surgical4 deaths7,609 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.