EndoWrist;daVinci Si 420207Recalls & reported problems

Summary

The FDA's MAUDE database contains 136 adverse event reports that list this exact device (DI 00886874111659), received between May 26, 2017 and Feb 19, 2026 — classified as 3 injuries, 133 malfunctions.

The most frequently reported specific device problem is “Break” (83 reports).

1 FDA recall record name this device's identifier, 1 still open.

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.

Recalls naming this device

1. Dec 9, 2025Class IIOpen, Classified

   Due to increased in complaints regarding frayed or broken pitch cables on reusable surgical instruments

   Z-1700-2026 · Root cause: Process change control · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 136 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 19, 2026Material Split, Cut or Torn

  IT WAS REPORTED THAT THERE WAS A BROKEN CABLE WITH A DA VINCI PRODUCT. THE CUSTOMER REPORTED EVENT HAS NO REPORT OF PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24395818 ↗
• MalfunctionMar 5, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE TENACULUM FORCEPS ARE FAULTY, THE TIP NO LONGER RESPONDING TO THE ROBOT AFTER 2 USES. THE PROCEDURE WAS COMPETED WITH NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21528665 ↗
• MalfunctionJan 3, 2025Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED MYOMECTOMY SURGICAL PROCEDURE THE WIRE WAS BROKEN ON THE TENACULUM FORCEPS INSTRUMENT. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER ON AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE SURGERY DATE IS CORRECT AS 12/04/2024 IN KOREAN TIME. THE SURGICAL TASK BEING PERFORMED WHEN THE ISSUE OCCURRED WAS GRASPING. THE INSTRUMENT DID NOT COLLIDE WITH ANY OTHER INSTRUMENT OR TOOL DURING THE PROCEDURE. NO FRAGMENTS FELL WITHIN THE PATIENT. THERE WAS A DELAY OF ROUGHLY 10 MINUTES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21064412 ↗
• MalfunctionJan 1, 2025Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED ENDOMETRIOSIS SURGICAL PROCEDURE, THE TENACULUM FORCEPS CABLE BROKE. THE PROCEDURE WAS COMPLETED WITH THE SAME INSTRUMENT WITH NO REPORTED INJURY. THE PROCEDURE WAS DELAYED LESS THAN 15 MINUTES. NO FRAGMENT FELL INTO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21050658 ↗
• MalfunctionJun 26, 2024Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED PROSTATECTOMY SURGICAL PROCEDURE, THE TENACULUM FORCEPS INSTRUMENT HAD A CABLE BREAKAGE. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE SITE AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE INSTRUMENT WAS INSPECTED BEFORE THE START OF SURGERY BY THE SCRUB NURSE, NO DAMAGE WAS SEEN TO THE INSTRUMENT. THE SURGEON WAS HOLDING THE PROSTATE. INSTRUMENT DID NOT COLLIDE WITH ANY TOOL OR INSTRUMENT. THE CUSTOMER DID NOT HAVE THE INSTRUMENT AVAILABLE AND COULD NOT ANSWER WHETHER THE ISSUE WAS RELATED TO OPENING/CLOSING GRIPS, LEFT/RIGHT (YAW) MOTION, OR UP/DOWN (PITCH) MOTION. THE CABLE WAS VISIBLE. NOTHING FELL INSIDE THE PATIENT. THE INSTRUMENT HAS ALREADY BEEN SENT TO STRATTNER. THERE ARE NO IMAGES AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19611803 ↗
• MalfunctionJan 3, 2024Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED MYOMECTOMY SURGICAL PROCEDURE, THE TENACULUM FORCEPS INSTRUMENT WAS FOUND TO HAVE A BROKEN CABLE. 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 CUSTOMER INDICATED THAT A STRAND OF CABLE WAS FOUND PROTRUDING FROM THE DISTAL END OF THE INSTRUMENT. THE INSTRUMENT DID NOT COLLIDE WITH ANY OTHER INSTRUMENT OR TOOL DURING THE PROCEDURE. THERE WAS NO REPORT OF FRAGMENT(S) FALLING INSIDE THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18433184 ↗
• MalfunctionDec 30, 2023Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED MYOMECTOMY SURGICAL PROCEDURE, THE TENACULUM FORCEPS INSTRUMENT HAD BROKEN CABLE. THE PROCEDURE WAS COMPLETED WITH NO REPORTS OF PATIENT INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE TENACULUM FORCEPS INSTRUMENT WAS INSPECTED PRIOR TO USE, AND NO DAMAGE WAS FOUND. THE STRAND OF CABLE WAS FOUND PROTRUDING FROM THE DISTAL END OF THE INSTRUMENT. THE INSTRUMENT DID NOT COLLIDE WITH ANY OTHER INSTRUMENT OR TOOL DURING THE PROCEDURE. THERE WAS NO REPORT OF FRAGMENT(S) FALLING INSIDE THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18422730 ↗
• MalfunctionJun 5, 2023Unintended System Motion; Failure to Align; Unintended System Motion; Failure to Align

  IT WAS REPORTED, DURING A DA VINCI-ASSISTED MYOMECTOMY SURGICAL PROCEDURE. THE SURGEON ATTEMPTED TO GRASP UTERUS TISSUE. HOWEVER, THE TENACULUM FORCEPS INSTRUMENT MOVED IN THE OPPOSITE DIRECTION. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17067334 ↗
• MalfunctionJun 5, 2023Unintended System Motion; Difficult to Open or Close; Unintended System Motion; Difficult to Open or Close

  IT WAS REPORTED, THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE. THE GRIP FAILED ON THE TENACULUM FORCEPS INSTRUMENT. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17067333 ↗
• MalfunctionJun 5, 2023Unintended System Motion; Failure to Align; Unintended System Motion; Failure to Align

  IT WAS REPORTED DURING A DA VINCI-ASSISTED MYOMECTOMY SURGICAL PROCEDURE, THE SURGEON ATTEMPTED TO GRASP UTERUS TISSUE HOWEVER THE TENACULUM FORCEPS INSTRUMENT MOVED IN THE OPPOSITE DIRECTION. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17067332 ↗
• MalfunctionJun 5, 2023Unintended System Motion; Unintended System Motion

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED MYOMECTOMY SURGICAL PROCEDURE, THE TENACULUM FORCEPS INSTRUMENT DID NOT ROTATE PROPERLY. THE PROCEDURE WAS COMPLETED WITH A REPLACEMENT DEVICE AND THERE WAS NO REPORT OF PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17067330 ↗
• MalfunctionJun 5, 2023Unintended System Motion; Unintended System Motion

  IT WAS REPORTED, DURING A DA VINCI-ASSISTED MYOMECTOMY SURGICAL PROCEDURE. THE TIP OF THE TENACULUM FORCEPS INSTRUMENT DID NOT ADJUST WELL. THE SITE REMOVED/RESEATED THE DRAPE. HOWEVER, THE ISSUE DID NOT RESOLVE. THE PROCEDURE WAS COMPLETED WITH A BACKUP INSTRUMENT. AND THERE WAS NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17067327 ↗
• MalfunctionJun 5, 2023Unintended System Motion; Failure to Align; Unintended System Motion; Failure to Align

  IT WAS REPORTED DURING A DA VINCI-ASSISTED MYOMECTOMY SURGICAL PROCEDURE, THE THE SYSTEM HAD ABNORMAL MOVEMENT OF THE TENACULUM FORCEPS. THE SITE REMOVED/RESEATED THE DRAPE, HOWEVER THE ISSUE DID NOT RESOLVE. THE PROCEDURE WAS COMPLETED WITH A BACKUP INSTRUMENT AND THERE WAS NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17067325 ↗
• MalfunctionMay 20, 2023Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED MYOMECTOMY SURGICAL PROCEDURE, THE TENACULUM FORCEPS INSTRUMENT HAD A BROKEN WIRE AT THE TIP. BACKUP INSTRUMENT OF DIFFERENT KIND WAS USED TO COMPLETE THE PROCEDURE. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. INTUITIVE SURGICAL INC. (ISI) FOLLOWED UP WITH THE CUSTOMER TO CONFIRM THAT THE INSTRUMENT WAS INSPECTED BEFORE THE PROCEDURE WITH NO ISSUES NOTED. THE SURGEON WAS TRYING TO GRASP TISSUE WHEN THE ISSUE WAS NOTICED. THERE WAS NO COLLISION WITH ANY OTHER INSTRUMENTS OR TOOLS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16970951 ↗
• MalfunctionNov 30, 2022Unintended System Motion; Unintended System Motion

  REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15884352 ↗
• MalfunctionAug 29, 2022Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT AFTER A DA VINCI-ASSISTED MYOMECTOMY SURGICAL PROCEDURE, THE TENACULUM FORCEPS INSTRUMENT HAD BROKEN CABLE. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. THE TENACULUM FORCEPS IS A MULTIPLE-USE ENDOSCOPIC INSTRUMENT WITH A GRASPING TIP TO BE USED IN CONJUNCTION WITH THE DA VINCI SYSTEM. THE INSTRUMENT IS DESIGNED TO GRAB, MANIPULATE, RETRACT, AND DISSECT TISSUE DURING A DA VINCI ASSISTED SURGICAL PROCEDURE. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE TENACULUM FORCEPS INSTRUMENT WAS INSPECTED PRIOR TO USE AND THE CUSTOMER WAS PERFORMING RETRACTION WHEN THE ISSUE OCCURRED. FRAGMENTS WERE NOT FELL INTO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15312198 ↗
• MalfunctionJul 28, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED MYOMECTOMY SURGICAL PROCEDURE, THE TENACULUM FORCEPS INSTRUMENT WAS FOUND TO HAVE A BROKEN WIRE. THERE WAS NO REPORT OF FRAGMENT(S) FALLING INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITH NO REPORT OF PATIENT INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER TO OBTAIN THE INFORMATION REGARDING PATIENT DEMOGRAPHICS, RELEVANT TESTING, AND MEDICAL HISTORY; HOWEVER, THE REPORTER WAS NOT ABLE TO PROVIDE THAT INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15124792 ↗
• MalfunctionJul 28, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED MYOMECTOMY SURGICAL PROCEDURE, THE TENACULUM FORCEPS INSTRUMENT WAS FOUND TO HAVE A BROKEN WIRE. THERE WAS NO REPORT OF FRAGMENT(S) FALLING INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITH NO REPORT OF PATIENT INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER TO OBTAIN THE INFORMATION REGARDING PATIENT DEMOGRAPHICS, RELEVANT TESTING, AND MEDICAL HISTORY; HOWEVER, THE REPORTER WAS NOT ABLE TO PROVIDE THAT INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15124552 ↗
• MalfunctionJul 10, 2022Break; Break

  IT WAS REPORTED THAT DURING DA VINCI-ASSISTED HYSTERECTOMY SURGICAL PROCEDURE, THE JAW OF THE TENACULUM FORCEPS INSTRUMENT WAS FOUND TO BE BROKEN. A BACKUP INSTRUMENT OF A DIFFERENT TYPE WAS USED AND THE PROCEDURE WAS COMPLETED 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 14973740 ↗
• MalfunctionJul 8, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED MYOMECTOMY SURGICAL PROCEDURE, THE TENACULUM FORCEPS INSTRUMENT HAD BROKEN CABLES. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY USING A BACKUP INSTRUMENT OF THE SAME KIND. INTUITIVE SURGICAL, INC. (ISI) CONTACTED THE INITIAL REPORTER, BUT WAS NOT ABLE TO OBTAIN ANY ADDITIONAL INFORMATION ABOUT THE COMPLAINT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14960928 ↗
• MalfunctionJul 8, 2022Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED MYOMECTOMY SURGICAL PROCEDURE, THE TENACULUM FORCEPS INSTRUMENT WAS FOUND TO HAVE A BROKEN WIRE. A BACKUP INSTRUMENT OF SAME KIND WAS USED TO CONTINUE THE PROCEDURE. THERE WAS NO REPORT OF FRAGMENT(S) FALLING INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITH NO REPORT OF PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14960314 ↗
• InjuryJun 29, 2022Difficult to Open or Close; Difficult to Open or Close

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE TENACULUM FORCEPS GRIP FAILED TO CLOSE NOR OPEN AND THE ¿CUSTOMER SHOULD REMOVE THE INSTRUMENT WITH THE DRAPE, AND THE INSTRUMENT STOPPED WORKING¿. THIS INSTRUMENT WAS INSTALLED ON ARM TWO AND HADN'T BEEN REMOVED FOR ABOUT 30 MINUTES. THE PATIENT WAS EXPERIENCING BLEEDING. THE PROCEDURE WAS CONVERTED TO A LAPAROSCOPIC PROCEDURE. UPON TROUBLESHOOTING, THE CUSTOMER REMOVED THE CANNULA, THE STERILE ADAPTOR, AND THE INSTRUMENT AND PERFORMED A POWER CYCLE OF THE SYSTEM. AFTER THE INSTRUMENT WAS REMOVED WITH THE STERILE ADAPTER, THE SURGEON CONTINUED THE PROCEDURE USING THE SAME DA VINCI SYSTEM. THERE WAS NO REPORT OF FRAGMENT(S) FALLING INSIDE THE PATIENT. ON 16-JUN-2021, INTUITIVE SURGICAL, INC. (ISI) OBTAINED THE FOLLOWING ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT: THE CAUSE OF THE BLEEDING IS UNKNOWN, AND THERE WAS A DELAY IN CONTROLLING THE BLEEDING SINCE THE SITE COULD NOT REMOVE THE TENACULUM FORCEPS INSTRUMENT. THE TENACULUM INSTRUMENT WAS REMOVED WITH THE STERILE ADAPTER. IT WAS REPORTED THAT THE SURGEON CONVERTED TO LAPAROSCOPIC SURGERY TO CONTROL THE BLEEDING, AND THEN THE PROCEDURE WAS COMPLETED

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 14856340 ↗
• MalfunctionJun 24, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING CENTRAL PROCESSING, THAT THE TENACULUM FORCEPS HAD A BROKEN CABLE. THERE WAS NO REPORT OF PATIENT INVOLVEMENT. THE TENACULUM FORCEPS IS A MULTIPLE-USE ENDOSCOPIC INSTRUMENT WITH A GRASPING TIP TO BE USED IN CONJUNCTION WITH THE DA VINCI SYSTEM. THE INSTRUMENT IS DESIGNED TO GRAB, MANIPULATE, RETRACT, AND DISSECT TISSUE DURING A DA VINCI ASSISTED SURGICAL PROCEDURE. AN ATTEMPT HAS BEEN MADE TO OBTAIN ADDITIONAL INFORMATION FROM THE CUSTOMER CONCERNING THE REPORTED EVENT WITH NO SUCCESS.

  Patient problems: Insufficient Information

  MAUDE report 14796520 ↗
• MalfunctionJun 10, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED MYOMECTOMY SURGICAL PROCEDURE, THE TENACULUM FORCEPS INSTRUMENT WAS FOUND TO HAVE A BROKEN WIRE. A BACKUP INSTRUMENT OF THE SAME KIND WAS USED TO CONTINUE THE PROCEDURE. THERE WAS NO REPORT OF FRAGMENT(S) FALLING INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITH NO REPORT OF PATIENT INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER TO OBTAIN THE INFORMATION REGARDING PATIENT DEMOGRAPHICS, RELEVANT TESTING, AND MEDICAL HISTORY; HOWEVER, THE REPORTER WAS NOT ABLE TO PROVIDE THAT INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14651891 ↗
• MalfunctionMay 15, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED MYOMECTOMY SURGICAL PROCEDURE, THE TENACULUM FORCEPS WAS FOUND TO HAVE BROKEN CABLES. A BACKUP INSTRUMENT OF THE SAME KIND WAS USED TO CONTINUE THE PROCEDURE. THERE WAS NO REPORT OF FRAGMENTS FALLING INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITH NO REPORT OF PATIENT INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER TO OBTAIN ADDITIONAL INFORMATION. HOWEVER, THE REPORTER WAS NOT ABLE TO PROVIDE FURTHER DETAILS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14403782 ↗