EndoWrist;daVinci Si 420296Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00886874111789), received between Sep 30, 2020 and Mar 18, 2026 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Material Fragmentation” (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 18, 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.

• MalfunctionMar 18, 2026Material Split, Cut or Torn

  REFER TO H11 FOR FOLLOW-UP INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24631957 ↗
• MalfunctionOct 15, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  REFER TO H11 FOR FOLLOW-UP INFORMATION.

  Patient problems: Insufficient Information

  MAUDE report 23296086 ↗
• MalfunctionJul 25, 2024Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE LARGE SUTURECUT NEEDLE DRIVER INSTRUMENT STEEL WIRE WAS FRACTURED. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE ISI CLINICAL SALES REPRESENTATIVE (CSR) AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE INSTRUMENT WAS INSPECTED PRIOR TO USE AND THERE WAS NO DAMAGE OR ABNORMALITY IN THE APPEARANCE. THE SURGICAL TASK WAS A PROSTATECTOMY - RADICAL SALVAGE. THE INSTRUMENT DID NOT COLLIDE WITH ANY OTHER INSTRUMENT OR TOOL DURING THE PROCEDURE. IT WAS UNABLE TO BE DETERMINED IF ISSUES WERE RELATED TO OPENING/CLOSING OF THE GRIPS, IT WAS A STEEL WIRE FRACTURE. IT WAS UNABLE TO BE DETERMINED IF ISSUES WERE RELATED TO LEFT/RIGHT (YAW) MOTION OF THE GRIPS, IT WAS A STEEL WIRE FRACTURE. IT WAS UNABLE TO BE DETERMINED IF ISSUES WERE RELATED TO UP/DOWN (PITCH) MOTION OF THE WRIST, IT WAS A STEEL WIRE FRACTURE. YES, TWO CABLES WERE VISIBLY PROTRUDING FROM THE DISTAL END OF THE INSTRUMENT. NO FRAGMENT FELL INSIDE THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19824072 ↗
• MalfunctionJun 27, 2024Material Fragmentation; Material Fragmentation

  REFER TO H11 FOR FOLLOW-UP INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19621472 ↗
• MalfunctionJan 25, 2024Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED MYOMECTOMY SURGICAL PROCEDURE, THE LARGE SUTURECUT NEEDLE DRIVER INSTRUMENT WAS FOUND TO HAVE THE CABLE BROKEN. THERE WAS NO REPORT OF FRAGMENT(S) FALLING INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITH A BACKUP INSTRUMENT OF SAME KIND. NO KNOWN IMPACT OR PATIENT CONSEQUENCE WAS REPORTED. 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 FOUND. THE ISSUE OCCURRED WHILE SUTURING THE TISSUE. THE INSTRUMENT DID NOT COLLIDE WITH ANY OTHER INSTRUMENT OR TOOL DURING THE PROCEDURE. THERE WERE NO ISSUES WITH THE OPENING/CLOSING OF THE GRIPS, LEFT/RIGHT MOTION OF THE GRIPS, OR UP/DOWN MOTION OF THE WRIST.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18577594 ↗
• MalfunctionSep 30, 2020Detachment of Device or Device Component; Device Dislodged or Dislocated; Detachment of Device or Device Component; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING CENTRAL PROCESSING, THE LARGE SUTURECUT NEEDLEDRIVER INSTRUMENT WAS UNABLE TO CLOSE COMPLETELY. THERE WAS NO REPORT OF PATIENT INVOLVEMENT. 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 Known Impact Or Consequence To Patient

  MAUDE report 10609667 ↗