EndoWrist;daVinci Si 420318Recalls & reported problems

Summary

The FDA's MAUDE database contains 55 adverse event reports that list this exact device (DI 00886874111802), received between Apr 18, 2017 and Jan 30, 2026 — classified as 2 injuries, 53 malfunctions.

The most frequently reported specific device problem is “Break” (41 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 25 most recent of 55 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 30, 2026Material Split, Cut or Torn

  REFER TO H11 FOR FOLLOW-UP INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24228377 ↗
• MalfunctionJan 30, 2026Material Split, Cut or Torn

  REFER TO H11 FOR FOLLOW-UP INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24227959 ↗
• MalfunctionJun 25, 2024Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED LOW ANTERIOR RESECTION SURGICAL PROCEDURE, THE SMALL GRASPING RETRACTOR INSTRUMENT HAD A BROKEN CABLE. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE INSTRUMENT WAS ALREADY BEING USED ON THE PATIENT WHEN THE ISSUE WAS IDENTIFIED. A BACKUP INSTRUMENT WAS USED FOR THE REST OF THE PROCEDURE. THE CUSTOMER WAS UNABLE TO IDENTIFY FURTHER ISSUES WITH THE INSTRUMENT ARTICULATION AS THE INSTRUMENT WAS REPLACED QUICKLY AFTER THE BROKEN CABLE WAS IDENTIFIED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19602896 ↗
• MalfunctionAug 7, 2023Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED TOTAL COLECTOMY SURGICAL PROCEDURE, THE SMALL GRASPING RETRACTOR INSTRUMENT HAD A BROKEN CABLE. THE PROCEDURE WAS COMPLETED AS PLANNED WITH NO REPORTED INJURY. 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 17474816 ↗
• MalfunctionDec 20, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED LEFT HEMICOLECTOMY SURGICAL PROCEDURE, THE 8MM SMALL GRASPING RETRACTOR INSTRUMENT HAD A BROKEN CABLE. THE PROCEDURE WAS COMPLETED WITH A BACK-UP INSTRUMENT WITH NO REPORTED INJURY. 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 13049286 ↗
• MalfunctionOct 18, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SIGMOID COLECTOMY SURGICAL PROCEDURE, A CABLE AT THE JOINT OF THE SMALL GRASPING RETRACTOR WAS TORN. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER ON (B)(6) 2021 AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE SITE CHANGED THE INSTRUMENT INTRAOPERATIVELY. THE PATIENT DEMOGRAPHIC INFORMATION WAS NOT PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12644616 ↗
• MalfunctionSep 27, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT AFTER A DA VINCI-ASSISTED LOW ANTERIOR RESECTION SURGICAL PROCEDURE, THE SMALL GRASPING RETRACTOR INSTRUMENT HAD DISENGAGED CABLES. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE SMALL GRASPING RETRACTOR WAS INSPECTED BY THE SCRUB TECH PRIOR TO USE. THE CLEANING OR STERILIZATION METHODS HAVE NOT RECENTLY CHANGED. THERE WERE NO IMAGES/VIDEO AVAILABLE OF THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12531203 ↗
• InjuryAug 25, 2021Material Fragmentation; Detachment of Device or Device Component; Material Fragmentation; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE SMALL GRASPING RETRACTOR INSTRUMENT WIRE WAS BROKEN AND A FRAGMENT FELL INTO THE PATIENT. THE FRAGMENT WAS RETRIEVED WITH A LAPAROSCOPIC INSTRUMENT DURING THE SAME PROCEDURE. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, IND. (ISI) FOLLOWED UP WITH THE CUSTOMER AND OBTAINED ADDITIONAL INFORMATION ON 27-JULY-2021. THE INSTRUMENT WAS REPORTEDLY INSPECTED PRIOR TO USE AND NO ISSUES WERE IDENTIFIED. THE INSTRUMENT WAS IN USE FOR AN UNKNOWN AMOUNT OF TIME, AND NO ISSUES WITH THE FUNCTIONALITY WERE NOTED. THERE WERE NO KNOWN COLLISIONS DURING THE PROCEDURE. IT WAS CONFIRMED THAT THE INSTRUMENT FRAGMENT WAS RETRIEVED SUCCESSFULLY DURING THE SAME PROCEDURE, THERE WERE NO POST-OPERATIVE TESTS TO LOOK FOR ADDITIONAL FRAGMENTS, AND THE PATIENT HAS NOT RETURNED TO THE HOSPITAL DUE TO ANY POST-SURGICAL COMPLICATIONS RELATED TO RETAINING A FOREIGN OBJECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12363979 ↗
• MalfunctionJul 19, 2021Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE ON AN UNKNOWN EVENT DATE, THE SMALL GRASPING RETRACTOR INSTRUMENT CABLE WAS BROKEN. A SIMILAR BACKUP DA VINCI INSTRUMENT WAS USED TO CONTINUE WITH THE CASE. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12186946 ↗
• MalfunctionJul 17, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED LOW ANTERIOR RESECTION SURGICAL PROCEDURE, MOVEMENT ON THE SMALL GRASPING RETRACTOR INSTRUMENT DID NOT WORK. THE INSTRUMENT HAD A LOOSE CABLE. THE PROCEDURE WAS COMPLETED USING A BACK-UP INSTRUMENT WITH NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12186136 ↗
• MalfunctionJul 17, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE SMALL GRASPING RETRACTOR WAS FOUND TO HAVE A BROKEN CABLE. A SIMILAR BACKUP DA VINCI INSTRUMENT WAS USED TO CONTINUE WITH THE CASE. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) CONTACTED THE REPORTER TO REQUEST ADDITIONAL INFORMATION RELATED TO THE EVENT. HOWEVER, THE CUSTOMER REPORTED THAT THERE WERE NO FURTHER DETAILS THAT COULD BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12186128 ↗
• MalfunctionJul 17, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE SMALL GRASPING RETRACTOR INSTRUMENT CABLE WAS BROKEN. THE PROCEDURE WAS COMPLETED BY USING A BACK-UP INSTRUMENT AND THERE WAS NO REPORTED INJURY. 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 12186122 ↗
• MalfunctionFeb 12, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED ADRENALECTOMY SURGICAL PROCEDURE, THE SMALL GRASPING RETRACTOR INSTRUMENT CABLE BROKE. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11324464 ↗
• MalfunctionJan 26, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, MOVEMENT ON THE SMALL GRASPING RETRACTOR INSTRUMENT DID NOT WORK, AND A CABLE WAS FOUND TO BE LOOSE. THE PROCEDURE WAS COMPLETED AND THERE WAS NO REPORT OF PATIENT INJURY OR HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11233494 ↗
• MalfunctionJan 22, 2021Break; Break

  IT WAS REPORTED THAT DURING CENTRAL PROCESSING, THE SMALL GRASPING RETRACTOR HAD A BROKEN CABLE. THERE WAS NO 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 11213844 ↗
• MalfunctionJan 22, 2021Break; Break

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, MOVEMENT ON THE SMALL GRASPING RETRACTOR INSTRUMENT DID NOT WORK, AND A CABLE WAS FOUND TO BE LOOSE. THE PROCEDURE WAS COMPLETED AND THERE WAS NO REPORT OF PATIENT INJURY OR HARM.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 11213725 ↗
• MalfunctionDec 20, 2020Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED RIGHT HEMICOLECTOMY SURGICAL PROCEDURE, THE SMALL GRASPING RETRACTOR INSTRUMENT HAD NON-INTUITIVE MOTION AND WAS FOUND TO HAVE A BROKEN STEEL CONTROL CABLE. A BACKUP INSTRUMENT OF THE SAME TYPE WAS USED AND THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER FOR ADDITIONAL INFORMATION; HOWEVER, NO RESPONSE HAS BEEN RECEIVED AT THIS TIME.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 11043066 ↗
• MalfunctionDec 16, 2020Break; Break

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE SMALL GRASPING RETRACTOR WAS FOUND TO HAVE A LOOSE CABLE. A SIMILAR BACKUP INSTRUMENT WAS USED TO PROCEED WITH THE CASE. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 11020005 ↗
• MalfunctionNov 24, 2020Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A DA VINCI ASSISTED PROCEDURE, THE SURGEON STATED THAT THE SMALL GRASPING RETRACTOR INSTRUMENT WAS NOT WORKING CORRECTLY. THEY NOTICED WIRES STICKING OUT FROM THE INSTRUMENT. THE INSTRUMENT WAS IMMEDIATELY REMOVED WITH NO INJURY TO THE PATIENT. THE PROCEDURE WAS COMPLETED AND THERE WAS NO PATIENT INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED PATIENT-RELATED INFORMATION, BUT NO OTHER DETAILS RELATED TO THE EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10896303 ↗
• MalfunctionSep 11, 2020Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10519659 ↗
• MalfunctionSep 10, 2020Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED LOW ANTERIOR RESECTION SURGICAL PROCEDURE, THE SMALL GRASPING RETRACTOR INSTRUMENT'S INTERNAL WIRE BROKE INTRAOPERATIVELY. A BACKUP INSTRUMENT OF THE SAME TYPE WAS USED AND THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE CUSTOMER, AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE INSTRUMENT WAS INSPECTED PRIOR TO USE. THE SURGEON WAS RETRACTING THE COLON WHEN THE REPORTED PROBLEM OCCURRED. NO INSTRUMENT COLLISIONS OCCURRED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10512769 ↗
• MalfunctionAug 5, 2020Break; Break

  THE CUSTOMER CONDUCTED AN INSPECTION OF THE INSTRUMENTS AND ACCESSORIES IN ANTICIPATION FOR A PLANNED DA VINCI-ASSISTED SURGICAL PROCEDURE. DURING INSPECTION, THE CUSTOMER FOUND THE SMALL GRASPING RETRACTOR TO HAVE A BROKEN WIRE AT THE TIP. THERE WAS NO PATIENT INVOLVEMENT. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER TO OBTAIN ADDITIONAL INFORMATION, BUT THE CUSTOMER WAS UNABLE TO PROVIDE ANY FURTHER DETAILS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10366180 ↗
• MalfunctionJul 21, 2020Break; Break

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE CUSTOMER STATED THAT THE SMALL GRASPING RETRACTOR INSTRUMENT CABLE WAS DEFECTIVE. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: A BACKUP INSTRUMENT WAS USED TO COMPLETE THE PROCEDURE. THE PROCEDURE WAS DELAYED FOR A FEW MINUTES DUE TO THE INSTRUMENT'S EXCHANGE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10303299 ↗
• MalfunctionJul 21, 2020Break; Break

  IT WAS REPORTED THAT DURING CENTRAL PROCESSING, THE SMALL GRASPING RETRACTOR INSTRUMENT AS FOUND TO HAVE A BROKEN CABLE. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE REPORTER CONFIRMED THAT THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10300326 ↗
• MalfunctionJul 16, 2020Break; Break

  IT WAS REPORTED THAT DURING A DA VINCI ASSISTED PROCEDURE, ENGAGEMENT OF THE SMALL GRASPING RETRACTOR INSTRUMENT WAS DEFECTIVE AND THE CUSTOMER WAS UNABLE TO CONTROL THE INSTRUMENT'S MOVEMENT. THE PROCEDURE WAS COMPLETED AND THERE WAS NO PATIENT INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE REPORTER STATED THAT THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10286263 ↗