Force Feedback 476093Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00886874125595), received between Jul 2, 2025 and May 18, 2026 — classified as 1 injury, 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.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• 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 ↗
• MalfunctionFeb 3, 2026Break

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE THE FORCE FEEDBACK PROGRASP FORCEPS INSTRUMENT SHEATH WAS BROKEN. THE CUSTOMER REPORTED EVENT HAS NO REPORT OF PATIENT INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER TO OBTAIN ADDITIONAL INFORMATION, HOWEVER, NO FURTHER DETAILS ARE AVAILABLE REGARDING THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24253901 ↗
• MalfunctionDec 11, 2025Break; Break

  IT WAS REPORTED THAT DURING CENTRAL PROCESSING, THE FORCE FEEDBACK INSTRUMENT SHAFT WAS BROKEN. THERE WAS NO REPORT OF PATIENT INVOLVEMENT OR REPORTED INJURY.

  Patient problems: Insufficient Information

  MAUDE report 23784092 ↗
• MalfunctionJul 2, 2025Break; Break

  REFER TO H11 FOR FOLLOW-UP INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22379912 ↗