None 470398Recalls & reported problems
Intuitive Surgical, Inc. · HASSON CONE · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 5
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00886874112656), received between May 27, 2023 and Apr 3, 2026 — classified as 5 malfunctions.
The most frequently reported specific device problem is “Break” (3 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Reports received per month
Most reported problems
Device problems
- Break3
- Crack1
- Detachment of Device or Device Component1
- Thermal Decomposition of Device1
Patient problems
- No Clinical Signs, Symptoms or Conditions5
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 3, 2026Thermal Decomposition of Device
REFER TO H11 FOR FOLLOW-UP INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24780122 ↗MalfunctionJan 29, 2026Break
IT WAS REPORTED THAT DURING DA VINCI-ASSISTED SURGICAL PROCEDURE, THE HASSON CONE WAS FOUND TO HAVE CRACK IN CLAMP PART. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24206826 ↗MalfunctionOct 23, 2025Break; Break
IT WAS REPORTED THAT DURING CENTRAL PROCESSING, THE HASSON CONE ACCESSORY WAS BROKEN. DID NOT USE ON PATIENT. THERE WAS NO REPORT OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23374281 ↗MalfunctionJun 18, 2025Crack; Crack
IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED UROLOGY PROSTATECTOMY SURGICAL PROCEDURE, THE HASSON CONE ACCESSORY HAD A DAMAGED CRACK IN THE CLAMP PART. THE PROCEDURE WAS COMPLETED AS PLANNED WITH NO REPORTED INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22287818 ↗MalfunctionMay 27, 2023Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component
IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, A WHITE PIECE BROKE OFF THE HASSON CONE. THE PROCEDURE WAS COMPLETED AS PLANNED WITH NO REPORTED INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17015587 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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