Harmonic HAR1120Recalls & reported problems
Ethicon Endo-Surgery, LLC · HARMONIC 1100 Shears, 20cm Shaft Length · Class U
Quick summary
This Ethicon Harmonic ultrasonic surgical shears is a handheld tool that cuts and seals tissue using ultrasonic vibration. Many of its 467 reports describe parts breaking or coming off, the device failing to read its input signal, and delayed activation. The reports include 10 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
- 456
- Deaths reported
- 0
- Injuries reported
- 10
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 456 adverse event reports that list this exact device (DI 10705036026174), received between Jun 30, 2021 and Sep 24, 2026 — classified as 10 injuries, 446 malfunctions.
The most frequently reported specific device problem is “Material Separation” (280 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 Separation280
- Failure to Read Input Signal174
- Difficult or Delayed Activation21
- Material Integrity Problem20
- Detachment of Device or Device Component13
- Insufficient Device Problem Information11
- No Apparent Adverse Event6
- Noise, Audible6
Patient problems
- No Clinical Signs, Symptoms or Conditions445
- Foreign Body In Patient8
- Hematoma3
- Insufficient Information2
- Arrhythmia1
- Burn(s)1
- Cardiac Arrest1
- Failure to Anastomose1
Recent adverse event reports
The 25 most recent of 456 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 24, 2026Failure to Read Input Signal
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50889627 ↗MalfunctionSep 24, 2026Material Separation
It was reported that, this was an open transverse colon case with severe adhesions and was a difficult case. At this time the blade damage was noticed, the blade had already broken and was missing, so a replacement device was used. An X-ray was taken postoperatively, but the blade was not found in the body. Therefore, it was determined that the blade had broken and been lost outside the body. The nurse in charge speculated that the blade may have developed a crack due to contact with the assistant during deep surgical manipulation. No pieces were left inside the patient. Another device was used to complete the case. There were no adverse consequences to the patient. No further information is available.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50886439 ↗MalfunctionSep 24, 2026Material Separation
It was reported that during an unknown procedure the device blade tip separated. No patient consequences reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50882451 ↗MalfunctionSep 23, 2026Material Separation
It was reported that during a colectomy procedure the blade broke. The broken blade was retrieved using a suction device. No pieces were left inside the patient. Another device was used to complete the case. There were no adverse consequences to the patient. No further information is available.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50870886 ↗MalfunctionSep 22, 2026Material Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50860268 ↗MalfunctionSep 22, 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 50854947 ↗MalfunctionSep 21, 2026Failure to Read Input Signal; No Apparent Adverse Event
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50842537 ↗MalfunctionSep 21, 2026Difficult or Delayed Activation; No Apparent Adverse Event
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50842411 ↗MalfunctionSep 15, 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 50773100 ↗MalfunctionSep 2, 2026Material Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50574592 ↗MalfunctionSep 2, 2026Material Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50569579 ↗MalfunctionAug 25, 2026Failure to Read Input Signal
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50434344 ↗MalfunctionAug 21, 2026Material Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50375292 ↗MalfunctionJul 30, 2026Material Separation
It was reported that during an unknown surgery, the active blade broke outside the body. No pieces were left inside the patient. Another device was used to complete the case. There were no adverse consequences to the patient. No further information is available.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50092587 ↗MalfunctionJun 11, 2026Difficult or Delayed Activation
IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THE DEVICE STOPPED WORKING, THE CLAMP DID NOT ACTIVATE AGAIN. THERE WERE NO PATIENT CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25472181 ↗MalfunctionJun 9, 2026Detachment of Device or Device Component
IT WAS REPORTED THAT DURING A LAPAROSCOPIC RADICAL RESECTION FOR COLON CANCER THE WHITE TISSUE PAD WAS COMPLETELY 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 25447638 ↗MalfunctionJun 9, 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 25445743 ↗MalfunctionJun 8, 2026Material Separation; Difficult or Delayed Activation
IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, SHORTLY AFTER THE START OF SURGERY, THE TIP FRACTURED SOON AFTER INITIAL USE OF THE HANDPIECE. THERE WERE NO PATIENT CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25436187 ↗MalfunctionJun 1, 2026Failure to Read Input Signal
IT WAS REPORTED THAT DURING A PANCREATIC RESECTION PROCEDURE, THE SURGERY WAS CONVERTED TO OPEN, AND THE HAR1120 WAS CONNECTED TO THE GENERATOR; HOWEVER, THE GENERATOR DID NOT RECOGNIZE THE DEVICE. AS THE DEVICE WAS NOT USED ON THE PATIENT, THERE WAS NO IMPACT ON THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25355788 ↗MalfunctionMay 18, 2026Failure to Read Input Signal
IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THERE WAS AN INSTRUMENT ERROR DETECTED UPON PLUGGING INSTRUMENT INTO GEN11 DURING SURGERY PREPARATION. THERE WERE NO PATIENT CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25211564 ↗MalfunctionMay 15, 2026Failure to Read Input Signal
IT WAS REPORTED THAT, DURING AN UNKNOWN PROCEDURE, AN UNKNOWN ERROR OCCURRED, SO THE DEVICE WAS NO LONGER CONTINUED TO USE. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25190599 ↗MalfunctionMay 14, 2026Material Integrity Problem
IT WAS REPORTED THAT DURING A THORACIC SURGERY THERE WAS A FRACTURE OF THE ACTIVE BLADE OF THE DEVICE. IT DID NOT CAUSE ANY COMPLICATIONS DURING SURGERY. OPEN A NEW HAR1120. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WERE NO PATIENT CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25170905 ↗MalfunctionMay 11, 2026Difficult or Delayed Activation; Detachment of Device or Device Component
IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THE FORCEPS STOPPED FUNCTIONING DURING THE PROCEDURE. THE TEFLON SLEEVE DETACHED FROM THE FORCEPS. THERE WERE NO PATIENT CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25136359 ↗MalfunctionMay 11, 2026Material Separation
IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THE PRODUCT WAS UNPACKED AND INSTALLED ON THE GENERATOR IN ACCORDANCE WITH THE STANDARD PROCEDURE. DURING THE SURGICAL PROCEDURE, THE TIP SUDDENLY BROKE INTRAOPERATIVELY. THE ISSUE WAS IMMEDIATELY NOTICED, AND THEREFORE NO ADVERSE EFFECTS OR RISKS TO THE PATIENT OCCURRED. A NEW HARMONIC INSTRUMENT WAS SUBSEQUENTLY OPENED AND THE PROCEDURE WAS COMPLETED WITHOUT FURTHER ISSUES. THERE WERE NO PATIENT CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25136130 ↗MalfunctionMay 7, 2026Failure to Read Input Signal; Detachment of Device or Device Component
IT WAS REPORTED THAT, DURING AN OPEN FREY PROCEDURE ¿CLEAN BLADE¿ WAS DISPLAYED ON THE 1ST GEN11 (1111438058). IT WAS CLEANED, AND THE ERROR CLEARED BRIEFLY, BUT ¿REPLACE INSTRUMENT¿ WAS DISPLAYED. THE PROCEDURE WAS RESUMED. IT WAS NOTICED THAT THE TISSUE PAD WAS DAMAGED, SO THE DEVICE WAS REPLACED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25116885 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.