Force Feedback 475205Recalls & reported problems
Intuitive Surgical, Inc. · Force Feedback Fenestrated Bipolar Forceps · Class 2
All models of Force Feedback (11)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00886874120743), received between Sep 30, 2024 and Jun 20, 2025 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Break” (1 report).
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
- Break1
- Detachment of Device or Device Component1
- Thermal Decomposition of Device1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 20, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
REFER TO H11 FOR FOLLOW-UP INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22302558 ↗MalfunctionDec 27, 2024Break; Break
IT WAS REPORTED THAT DURING CENTRAL PROCESSING, THE SHAFT WAS BROKEN OFF FROM THE FORCE FEEDBACK FENESTRATED BIPOLAR FORCEPS. THERE WAS NO REPORTED PATIENT IMPACT OR HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21024340 ↗MalfunctionSep 30, 2024Thermal Decomposition of Device; Thermal Decomposition of Device
IT WAS REPORTED THAT DURING CENTRAL PROCESSING, THE FORCE FEEDBACK FENESTRATED BIPOLAR FORCEPS HAD MELTED PLASTIC COMPONENT OF THE JAWS. THE PROCEDURE WAS COMPLETED AS PLANNED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: DAMAGE WAS IDENTIFIED AT THE BEGINNING OF THE DECONTAMINATION PROCESS. THE DAMAGE WAS OBSERVED AFTER USE IN THE OPERATING ROOM. BEFORE THEN, NO DAMAGE WAS NOTED. THE DAMAGE WAS NOT IDENTIFIED DURING PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20331509 ↗
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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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