Harmonic HARHD20Recalls & reported problems
Ethicon Endo-Surgery, LLC · HARMONIC HD 1000i Shears, 20cm 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 ultrasonic surgical instrument is a pair of shears. Of the 610 reports naming it, many describe internal material separating and the device failing to read its input signal, while others describe the titanium tip breaking off during surgery. The reports include 8 injuries and 1 death. One recall, open since July 2021, concerns an internal part that may crack and get stuck behind the energy button, possibly causing continuous activation and 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
- 609
- Deaths reported
- 1
- Injuries reported
- 8
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 609 adverse event reports that list this exact device (DI 10705036015048), received between Dec 5, 2017 and Sep 23, 2026 — classified as 1 death, 8 injuries, 600 malfunctions.
The most frequently reported specific device problem is “Material Separation” (312 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-2355-2021 · Root cause: Process control · FDA record ↗
Most reported problems
Device problems
- Material Separation312
- Failure to Read Input Signal139
- Detachment of Device or Device Component65
- Break50
- Material Integrity Problem36
- Difficult or Delayed Activation16
- Device Displays Incorrect Message14
- Device Alarm System13
Patient problems
- No Clinical Signs, Symptoms or Conditions472
- No Consequences Or Impact To Patient134
- Hemorrhage/Blood Loss/Bleeding3
- No Code Available2
- Partial thickness (Second Degree) Burn2
- Blood Loss1
- Cardiac Arrest1
- Failure to Anastomose1
Recent adverse event reports
The 25 most recent of 609 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 23, 2026Detachment of Device or Device Component
It was reported that during an unknown procedure the white tissue pad completely fell off. 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 50870724 ↗MalfunctionSep 23, 2026Detachment of Device or Device Component
It was reported that during an unknown procedure the white tissue pad completely fell off. The fallen piece was retrieved by forceps and was disposed off. 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 50870651 ↗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 50869842 ↗MalfunctionSep 18, 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 50817648 ↗MalfunctionSep 15, 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 50775252 ↗MalfunctionMay 28, 2026Material Separation
IT WAS REPORTED THAT DURING A LUNG TRANSPLANTATION SURGERY 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 25317555 ↗MalfunctionMay 21, 2026Material Separation
IT WAS REPORTED THAT DURING A GASTRECTOMY 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 25243274 ↗MalfunctionMay 15, 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 25184238 ↗MalfunctionMay 14, 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 25173590 ↗MalfunctionMay 12, 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 25150048 ↗MalfunctionApr 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 24965611 ↗MalfunctionMar 16, 2026Difficult or Delayed Activation; Activation, Positioning or Separation Problem
IT WAS REPORTED THAT DURING A MEDIASTINAL TUMOR RESECTION SURGERY THE DEVICE COULD NOT BE ACTIVATED DURING PROCEDURE. 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 24604784 ↗MalfunctionMar 3, 2026Failure to Read Input Signal
IT WAS REPORTED THAT DURING A LIVER RESECTION 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 24501059 ↗MalfunctionFeb 12, 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 24326311 ↗MalfunctionJan 30, 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 24222087 ↗MalfunctionJan 16, 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 24093824 ↗MalfunctionJan 7, 2026Failure to Read Input Signal
IT WAS REPORTED THAT DURING AN ESOPHAGEAL 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 23990580 ↗MalfunctionJan 6, 2026Material Separation
IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THE BLADE BROKE. NO ADDITIONAL INFORMATION CAN BE PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23978327 ↗MalfunctionJan 5, 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 23967544 ↗MalfunctionDec 23, 2025Failure to Read Input Signal; Failure 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 23879002 ↗MalfunctionDec 17, 2025Material Separation; Material Integrity Problem; Material Separation; Material Integrity Problem
IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THE DEVICE CANNOT BE ACTIVATED, COATING CRACKED, NO RESIDUE FOUND AT THE BROKEN END. CHANGED TO ANOTHER ONE TO COMPLETE SURGERY. NO ADDITIONAL INFORMATION CAN BE PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23830040 ↗MalfunctionDec 10, 2025Material Separation; Material Separation
IT WAS REPORTED THAT DURING AN INGUINAL HERNIA REPAIR 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 23767750 ↗MalfunctionDec 5, 2025Difficult or Delayed Activation; Difficult 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 23732566 ↗MalfunctionDec 1, 2025Material Separation; Material Separation
IT WAS REPORTED THAT DURING A GASTRECTOMY 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 23685740 ↗MalfunctionDec 1, 2025Material Separation; Material Separation
IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THERE WAS INTRAOPERATIVE BLADE FRACTURE. NO ADDITIONAL INFORMATION CAN BE PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23682325 ↗
Other Instrument, ultrasonic surgical devices
- Harmonic ACE HARH36Ethicon Endo-Surgery, LLC · Instrument, ultrasonic surgical4 deaths7,609 reports
- 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
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.