Force FeedbackRecalls & reported problems across all models
Intuitive Surgical, Inc. · 11 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 51
- Deaths reported
- 0
- Injuries reported
- 9
- Recalls
- 0
We found 11 models of Force Feedback by Intuitive Surgical, Inc. in the FDA's device registry (GUDID). Together they are named in 51 adverse event reports in the FDA's MAUDE database, received between Sep 30, 2024 and Aug 11, 2026 — classified as 9 injuries, 42 malfunctions.
The most frequently reported specific device problem is “Break” (25 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported Force Feedback problems
Device problems
- Break25
- Material Fragmentation7
- No Apparent Adverse Event5
- Detachment of Device or Device Component3
- Material Separation2
- Material Split, Cut or Torn2
- No Device Output2
- Crack1
Patient problems
- No Clinical Signs, Symptoms or Conditions36
- Insufficient Information15
- Bacterial Infection1
Force Feedback models
11 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Force Feedback 476205System, surgical, computer controlled instrument18 reports
- Force Feedback 476049System, surgical, computer controlled instrument8 reports
- Force Feedback 476309System, surgical, computer controlled instrument8 reports
- Force Feedback 476093System, surgical, computer controlled instrument6 reports
- Force Feedback 475205System, surgical, computer controlled instrument3 reports
- Force Feedback 475049System, surgical, computer controlled instrument2 reports
- Force Feedback 475093System, Surgical, Computer Controlled Instrument2 reports
- Force Feedback 475006System, surgical, computer controlled instrument1 report
- Force Feedback 475172System, surgical, computer controlled instrument1 report
- Force Feedback 475309System, Surgical, Computer Controlled Instrument1 report
- Force Feedback 476172System, surgical, computer controlled instrument1 report
Recent Force Feedback adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionAug 11, 2026Break
It was reported that the customer experienced an issue with an Intuitive product. The customer reported event has no report of patient injury. Intuitive Surgical, Inc. (ISI) made multiple follow up attempts to obtain additional information, however, no further details have been received as of date of this report.
Patient problems: Insufficient Information
MAUDE report 50216671 ↗MalfunctionMay 18, 2026Detachment of Device or Device Component
IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE CUSTOMER EXPERIENCED DIFFICULTY REMOVING THE FORCE FEEDBACK PROGRASP FORCEPS (FFPF) INSTRUMENT FROM ONE OF THE ARMS BECAUSE A PIN WAS DISLODGED AND PREVENTED THE INSTRUMENT FROM RETRACTING THROUGH THE CANNULA. THE CUSTOMER MANUALLY PUSHED THE PIN BACK INTO PLACE AND WAS THEN ABLE TO REMOVE THE INSTRUMENT FROM THE CANNULA. THE PROCEDURE WAS COMPLETING AS PLANNED WITH NO REPORTED INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25210413 ↗MalfunctionMay 6, 2026Tactile Prompts/Feedback
IT WAS REPORTED THAT DURING A DA VINCI ASSISTED SURGICAL PROCEDURE, POTENTIAL ERRORS OCCURRED REPEATEDLY. AFTER 3 RETRIES, A DIFFERENT FORCE FEEDBACK ARM WAS RECOGNIZED AND NORMAL OPERATION WAS CONFIRMED. THE CORRESPONDING ARM IS NOT BEING RECOGNIZED; THIS IS PRESUMED TO BE AN ERROR ISSUE. THE CUSTOMER REPORTED EVENT HAS NO REPORT OF PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25105105 ↗InjuryMay 5, 2026Material Separation
IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED LOW ANTERIOR RESECTION (LAR) PROCEDURE, A PIECE OF THE DISTAL SHAFT COVERING WAS NOTICED BROKEN OFF FROM A FENESTRATED BIPOLAR FORCEPS (FBF) INSTRUMENT. THE STAFF NOTICED THE ISSUE WHILE EXCHANGING INSTRUMENTS. A FRAGMENT FELL INSIDE THE PATIENT AND WAS REMOVED FROM THE PATIENT DURING THE SAME SURGICAL PROCEDURE WHICH WAS COMPLETED ROBOTICALLY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE FBF INSTRUMENT WAS NOT FOUND TO HAVE ANY DEFECTS PRIOR TO THE CASE. HOWEVER, THE INSTRUMENT BREAKAGE WAS DISCOVERED AFTER REMOVAL OF THE DEVICE FROM THE PATIENT. THE INSTRUMENT APPEARED TO FUNCTION PROPERLY DURING THE CASE. A LARGE FRAGMENT FELL INSIDE THE PATIENT BUT WAS RETRIEVED USING A LAPAROSCOPIC INSTRUMENT. ALL PIECES WERE CONFIRMED INTACT BY RECONSTRUCTING THEM ON THE BACK TABLE. NO ADDITIONAL SURGERY, IMAGING, OR CONVERSION FROM ROBOTIC TECHNIQUE WAS NEEDED, AND NO INJURY OR POST-SURGICAL COMPLICATIONS OCCURRED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25087354 ↗MalfunctionMay 4, 2026Break
IT WAS REPORTED THAT DURING CENTRAL PROCESSING, THE CUSTOMER NOTED THE FORCE FEEDBACK CADIERE FORCEPS JAW WAS BROKEN. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25074609 ↗MalfunctionApr 27, 2026Break
IT WAS REPORTED THAT THE FORCE FEEDBACK FENESTRATED BIPOLAR FORCEPS INSTRUMENT WAS BROKEN. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24994237 ↗MalfunctionApr 24, 2026Break
IT WAS REPORTED THAT DURING CENTRAL PROCESSING, THE INSTRUMENT END PIECE WAS CRACKED. THERE WAS NO REPORT OF PATIENT INVOLVEMENT OR REPORTED INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24990562 ↗InjuryApr 17, 2026Material Fragmentation
IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED GASTRIC BYPASS PROCEDURE, A SMALL CURVED METALLIC FRAGMENT FELL FROM THE FORCE FEEDBACK CADIERE FORCEPS INSTRUMENT AND WAS RETRIEVED FROM THE PATIENT'S ABDOMEN DURING THE SAME PROCEDURE. THE CUSTOMER CONFIRMED THAT ALL VISIBLE FRAGMENTS WERE RETRIEVED; ONE PIECE WAS IDENTIFIED AND REMOVED USING A LAPAROSCOPIC GRASPER. THE PIECE WAS SMALL, AND NO POST-OPERATIVE IMAGING SUCH AS X-RAY OR ULTRASOUND WAS PERFORMED. IT WAS NOT KNOWN WHETHER THE PATIENT HAD RETURNED TO THE HOSPITAL, BUT NO COMPLICATIONS OR ADDITIONAL SURGICAL PROCEDURES WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24917957 ↗MalfunctionApr 13, 2026Material Fragmentation
IT WAS REPORTED THAT PRIOR TO STARTING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THERE WAS A SPLINTER ON THE RESIN TIP OF THE FORCE FEEDBACK FENESTRATED BIPOLAR FORCEPS. THE PROCEDURE WAS CONTINUED AS PLANNED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH A NURSE FROM THE SITE AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE NURSE WAS NOT PRESENT FOR THE PROCEDURE. THE DAMAGE WAS DISCOVERED DURING PRE-OPERATIVE PREPARATIONS, BUT THE TIMING OF THE DAMAGE IS UNKNOWN. THERE WAS NO REPORT OF FRAGMENTS FALLING FROM THE DEVICE WHILE USED WITHIN A PATIENT. THE PATIENT HAS NOT RETURNED TO THE HOSPITAL DUE TO EXPERIENCING ANY POST-SURGICAL COMPLICATIONS RELATED TO RETAINING A FOREIGN OBJECT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24866492 ↗MalfunctionMar 9, 2026No Device Output
IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE FORCE FEEDBACK MEGA SUTURECUT NEEDLE DRIVER WOULD NOT ENGAGE. THE PROCEDURE WAS COMPLETED AS PLANNED WITH NO REPORTED INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24552406 ↗MalfunctionFeb 25, 2026No Apparent Adverse Event
REFER TO H11 FOR FOLLOW-UP INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24450211 ↗MalfunctionFeb 24, 2026Detachment of Device or Device Component
IT WAS REPORTED THAT THE FORCE FEEDBACK FENESTRATED BIPOLAR FORCEPS INSTRUMENT CAME APART PRIOR TO IT BEING USED. THERE WAS NO REPORT OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24437149 ↗InjuryFeb 23, 2026Material Fragmentation
IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE TIP BROKE OFF ON THE FORCE FEEDBACK FENESTRATED BIPOLAR FORCEPS. A FRAGMENT FELL INTO THE PATIENT AND WAS RETRIEVED DURING THE SAME PROCEDURE. THE PROCEDURE WAS COMPLETED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24413747 ↗MalfunctionFeb 13, 2026Break
IT WAS REPORTED THAT THE CUSTOMER EXPERIENCED A CRACKED SHAFT. THE CUSTOMER REPORTED EVENT HAS NO REPORT OF PATIENT INJURY.
Patient problems: Insufficient Information
MAUDE report 24338993 ↗InjuryFeb 11, 2026Material Separation
IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE PIN FELL OFF THE TIP OF THE FORCE FEEDBACK INSTRUMENT AND INTO THE PATIENT. THE FRAGMENT WAS RETRIEVED DURING THE SAME PROCEDURE. THE PIN WAS PLACED IN A JAR ACCOMPANYING THE INSTRUMENT. THE PROCEDURE WAS COMPLETED. 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 24313574 ↗
Other Intuitive Surgical, Inc. products
- EndoWrist62 models · 69,753 reports · 48 recalls
- daVinci Xi4 models · 11,477 reports · 3 recalls
- EndoWrist;daVinci Si35 models · 1,683 reports · 8 recalls
- daVinci 53 models · 1,608 reports · 5 recalls
- da Vinci Surgical System9 models · 1,459 reports · 5 recalls
- Ion6 models · 1,367 reports · 3 recalls
- SureForm16 models · 1,190 reports · 3 recalls
- EndoWrist SP20 models · 993 reports · 1 recall
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- 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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