Force Feedback 476049Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00886874125564), received between Oct 15, 2025 and May 4, 2026 — classified as 3 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Break” (4 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• 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 ↗
• MalfunctionFeb 6, 2026No Apparent Adverse Event

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24284452 ↗
• MalfunctionJan 30, 2026Break; Crack

  IT WAS REPORTED THAT THE FORCE FEEDBACK CADIERE FORCEPS INSTRUMENT DROPPED ON THE FLOOR AND CRACKED AT THE DISTAL END. NO KNOWN IMPACT OR PATIENT CONSEQUENCE WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24226257 ↗
• MalfunctionJan 30, 2026Break

  IT WAS REPORTED THAT DURING CENTRAL PROCESSING, THE 8MM FORCE FEEDBACK CADIERE FORCEPS INSTRUMENT TIP WAS DAMAGED. THERE WAS NO REPORT OF PATIENT INVOLVEMENT OR PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24225321 ↗
• MalfunctionDec 10, 2025Break; Break

  REFER TO H11 FOR FOLLOW-UP INFORMATION.

  Patient problems: Insufficient Information

  MAUDE report 23765214 ↗
• InjuryOct 15, 2025Material Fragmentation; Material Fragmentation

  REFER TO H11 FOR FOLLOW-UP INFORMATION.

  Patient problems: Bacterial Infection; No Clinical Signs, Symptoms or Conditions

  MAUDE report 23300950 ↗
• InjuryOct 15, 2025Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED RIGHT HEMICOLECTOMY PROCEDURE, THE SHAFT OF THE FORCE FEEDBACK CADIERE FORCEPS BROKE INSIDE THE PATIENT. THE CUSTOMER STATED THE PLASTIC ON THE SHAFT OF THE INSTRUMENT BROKE OFF INSIDE THE PATIENT. THE CUSTOMER RETRIEVED THE PIECES DURING THE SAME PROCEDURE WHICH WAS COMPLETED ROBOTICALLY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE INSTRUMENT WAS INSPECTED PRIOR TO USE, AND NO DAMAGE WAS NOTED. THE SURGICAL TASK BEING PERFORMED AT THE TIME OF THE FRAGMENT FELL INSIDE THE PATIENT WAS RETRACTION OF TISSUE. IT IS UNKNOWN HOW LONG THE INSTRUMENT WAS IN USE WHEN THE ISSUE WAS IDENTIFIED. THE INSTRUMENT DID NOT COLLIDE WITH ANY OTHER INSTRUMENTS OR OTHER HARD MATERIAL DURING THE SURGICAL PROCEDURE. THE INSTRUMENT WAS NEVER REMOVED FROM THE PATIENT UNTIL IT WAS NOTICED TO BE BROKEN. THE SURGICAL STAFF DID NOT FEEL ANY RESISTANCE UPON REMOVAL OF THE INSTRUMENT THROUGH THE CANNULA. AFTER REMOVING THE INSTRUMENT, THE STAFF NOTICED ANOTHER PIECE MISSING. THE FIRST PIECE WAS REMOVED ROBOTICALLY; TWO ADDITIONAL FRAGMENTS WERE ATTACHED TO THE SPECIMEN. THE FRAGMENTS WE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23297541 ↗