Force Feedback 476309Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00886874125601), received between May 21, 2025 and Feb 25, 2026 — classified as 1 injury, 7 malfunctions.

The most frequently reported specific device problem is “Break” (6 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.

• MalfunctionFeb 25, 2026No Apparent Adverse Event

  REFER TO H11 FOR FOLLOW-UP INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24450211 ↗
• MalfunctionJan 30, 2026Break

  IT WAS REPORTED THAT DURING CENTRAL PROCESSING, THE FORCE FEEDBACK MEGA SUTURE NEEDLE DRIVER HAD A CRACKED AT THE DISTAL SHEATH. NO KNOWN IMPACT OR PATIENT CONSEQUENCE WAS REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 24225319 ↗
• InjuryDec 23, 2025Material Fragmentation; Material Fragmentation

  REFER TO H11 FOR FOLLOW-UP INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23878070 ↗
• MalfunctionDec 11, 2025Break; Break

  REFER TO H11 FOR FOLLOW-UP INFORMATION.

  Patient problems: Insufficient Information

  MAUDE report 23784116 ↗
• MalfunctionJun 7, 2025Break; Break

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED LIVER RESECTION SURGICAL PROCEDURE, THE FORCE FEEDBACK MEGA SUTURECUT NEEDLE DRIVER WAS CRACKED AT THE TIP. THE PROCEDURE WAS COMPLETED AS PLANNED WITH NO REPORTED INJURY. THE REPORTED ISSUE WAS IDENTIFIED WHILE THE INSTRUMENT WAS BEING PLACED THROUGH THE TROCAR DURING A LIVER RESECTION PROCEDURE. IT IS UNKNOWN WHEN THE INSTRUMENT DAMAGE OCCURRED. THE REPORTER INFORMED THAT IS IT UNKNOWN WHETHER OR NOT THE CRACK AT THE TIP OF THE INSTRUMENT RESULTED IN A FRAGMENT, BUT THERE WAS NO FRAGMENT REPORTED BY THE STAFF. THE PROCEDURE WAS COMPLETED AS PLANNED WITHOUT ANY INJURY OR HARM TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22163986 ↗
• MalfunctionMay 21, 2025Break; Break

  REFER TO H11 FOR FOLLOW-UP INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22058274 ↗
• MalfunctionMay 21, 2025Break; Break

  REFER TO H11 FOR FOLLOW-UP INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22058270 ↗
• MalfunctionMay 21, 2025Break; Break

  IT WAS REPORTED THAT DURING CENTRAL PROCESSING, THE SHAFT OF THE FORCE FEEDBACK MEGA SUTURECUT NEEDLE DRIVER BROKE AT THE HEAD OF THE INSTRUMENT. THERE WAS NO REPORT OF PATIENT INVOLVEMENT. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE INSTRUMENT BROKE WHILE BEING CLEANED IN THE STERILE PROCESSING DEPARTMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22058269 ↗