None 480275Recalls & reported problems
Intuitive Surgical, Inc. · HARMONIC ACE · Class 2
Quick summary
This Intuitive Harmonic Ace is a computer-controlled surgical instrument used with da Vinci robotic systems. Its 2,321 reports often describe parts breaking off or detaching, and some mention fragments ending up inside patients. They also mention 889 injuries and 1 death. 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
- 2,324
- Deaths reported
- 1
- Injuries reported
- 897
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2,324 adverse event reports that list this exact device (DI 00886874112731), received between Mar 23, 2018 and Sep 30, 2026 — classified as 1 death, 897 injuries, 1,426 malfunctions.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (1,113 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
- Detachment of Device or Device Component1,113
- Break751
- No Device Output202
- Material Fragmentation180
- Output Problem76
- Material Integrity Problem30
- Thermal Decomposition of Device28
- Material Separation23
Patient problems
- No Clinical Signs, Symptoms or Conditions1,748
- Foreign Body In Patient390
- Insufficient Information140
- Device Embedded In Tissue or Plaque69
- No Known Impact Or Consequence To Patient20
- Hemorrhage/Blood Loss/Bleeding11
- Unspecified Tissue Injury7
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available2
Recent adverse event reports
The 25 most recent of 2,324 reports, in the reporter's own words as published by the FDA.
InjurySep 30, 2026Material Fragmentation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50954553 ↗MalfunctionSep 30, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50953592 ↗MalfunctionSep 30, 2026Detachment of Device or Device Component
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50953171 ↗InjurySep 30, 2026Material Fragmentation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50952792 ↗MalfunctionSep 30, 2026No Apparent Adverse Event
It was reported that during a da Vinci-assisted surgical procedure, a 8mm Harmonic Ace instrument had a blade activation failure. The procedure was completing as planned with no reported injury.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50942385 ↗MalfunctionSep 28, 2026Break
It was reported that during a da Vinci-assisted surgical procedure, the cutting tip/blade of the Harmonic Ace instrument was fractured. No fragment fell into the patient. The user completed the procedure and no known impact or patient consequence was reported.ISI made multiple follow-up attempts to obtain additional information. However, no further details have been received as of the date of this report.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50910833 ↗MalfunctionSep 25, 2026No Apparent Adverse Event
Patient problems: Insufficient Information
MAUDE report 50905854 ↗MalfunctionSep 25, 2026No Device Output
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50905024 ↗InjurySep 25, 2026Material Fragmentation
It was reported that during a da Vinci-assisted procedure, a screw on a Harmonic Ace instrument was observed to have loosened or broken and a fragment fell inside the patient. The fragment was retrieved during the same surgery.The customer stated that the broken fragment was immediately retrieved using a long forceps instrument along with another robotic arm. To confirm complete retrieval, the surgical site was thoroughly irrigated and carefully inspected using the da Vinci robotic endoscope, ensuring no fragments remained in the area. A postoperative ultrasound examination was conducted following the visual confirmation that no residual fragment was present.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50899446 ↗MalfunctionSep 24, 2026Break; Output Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50890605 ↗InjurySep 24, 2026Material Fragmentation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50887079 ↗InjurySep 24, 2026Material Fragmentation
It was reported that during a da Vinci-assisted procedure, the blade of the Harmonic Ace instrument was broken, and a fragment fell inside the patient. The fragment was retrieved during the same procedure. The procedure was completed. No post-operative tests were performed. Intuitive Surgical, Inc. (ISI) made multiple follow-up attempts to obtain additional information. However, no further details have been received as of the date of this report.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50885141 ↗MalfunctionSep 24, 2026Output Problem
It was reported that during a da Vinci-assisted surgical procedure, 8mm Harmonic Ace instrument had the error message "please relieve blade pressure" appearing while in use. The procedure was completed with no reported injury.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50877546 ↗MalfunctionSep 23, 2026No Device Output
Patient problems: Insufficient Information
MAUDE report 50875983 ↗MalfunctionSep 23, 2026Break
Patient problems: Insufficient Information
MAUDE report 50875895 ↗MalfunctionSep 23, 2026Output Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50875872 ↗MalfunctionSep 23, 2026No Device Output
It was reported that during a da Vinci-assisted surgical procedure, when using the Harmonic ACE instrument, it was found that it was not recognized and replaced with a new one. The procedure was completed with no reported injury.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50864047 ↗MalfunctionSep 3, 2026Output Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50579771 ↗MalfunctionAug 26, 2026Thermal Decomposition of Device
It was reported that during a da Vinci-assisted surgical procedure, the Harmonic ACE teflon pad was melted. The user completed the procedure with no further issue reported. No fragment fell inside the patient. No known impact or patient consequence was reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50463648 ↗InjuryAug 21, 2026Material Fragmentation
It was reported that during a da Vinci¿assisted low anterior resection procedure, the Harmonic Ace blade tip fractured and a fragment fell inside the patient. The fragment was retrieved using laparoscopic instruments during the same procedure which was completed robotically.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50380989 ↗InjuryAug 20, 2026Material Fragmentation
It was reported that during a da Vinci-assisted low anterior resection procedure, the blade tip of the Harmonic Ace instrument fractured and a fragment fell inside the patient. All fragments were retrieved during the same procedure which was completed robotically.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50356478 ↗MalfunctionAug 18, 2026Thermal Decomposition of Device
It was reported that during a da Vinci-assisted cholecystectomy surgical procedure, the tip of the Harmonic ACE seemed to melt during use. Customer had to get a new handpiece and cord. Customer continued the procedure as expected.The procedure was completed with no reported injury.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50310175 ↗MalfunctionAug 13, 2026Break
It was reported that during a daVinci assisted surgical procedure, the customer identified that the Harmonic Ace instrument had a broken tip. The procedure was completed.
Patient problems: Insufficient Information
MAUDE report 50231336 ↗MalfunctionAug 13, 2026No Device Output
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50231293 ↗MalfunctionAug 11, 2026Thermal Decomposition of Device
It was reported that during da Vinci-assisted surgical procedure, the teflon pad of Harmonic Ace instrument melted. The procedure was completed with no reported injury.Intuitive Surgical, Inc. (ISI) followed up with the initial reporter however the customer was unable to provide additional information.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50216619 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.