EndoWrist;daVinci Si 420184Recalls & reported problems

Summary

The FDA's MAUDE database contains 123 adverse event reports that list this exact device (DI 00886874111543), received between Feb 24, 2017 and Sep 29, 2026 — classified as 5 injuries, 116 malfunctions.

The most frequently reported specific device problem is “Break” (57 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 123 reports, in the reporter's own words as published by the FDA.

• OtherSep 29, 2026Arcing

  It was reported that during a da Vinci-assisted surgical procedure, customer noticed sparks coming from the Permanent Cautery Spatula instrument insulation of the electrocautery tip while clearing pelvic lymph nodes. The procedure was completed with no reported injury. The arcing appear to originate/occur from equipment, wrists, insulating materials and places. The arc grounded on patient anatomy when the monopolar Coag energy was activated. Burnt insulation was noticed on the instrument. The instrument tips did not collide with any other instrument or tool during procedure. It was reported that there was no injury to the patient. The procedure was completed as planned.

  Patient problems: Insufficient Information

  MAUDE report 50931441 ↗
• OtherSep 1, 2026Thermal Decomposition of Device; Arcing

  Patient problems: Burn(s); Insufficient Information

  MAUDE report 50542044 ↗
• MalfunctionMar 25, 2026No Device Output

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE 8MM PERMANENT CAUTERY SPATULA INSTRUMENT COULD NOT BE RECOGNIZED. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24684334 ↗
• MalfunctionOct 15, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT THE CUSTOMER EXPERIENCED AN ISSUE WITH AN INTUITIVE PRODUCT. THE CUSTOMER REPORTED EVENT HAS NO REPORT OF PATIENT INJURY. ISI FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THERE WAS NO INJURY TO THE PATIENT.

  Patient problems: Insufficient Information

  MAUDE report 23295843 ↗
• MalfunctionSep 3, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE CUSTOMER EXPERIENCED AN ISSUE WITH AN INTUITIVE PRODUCT. THE CUSTOMER REPORTED EVENT HAS NO REPORT OF PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22959113 ↗
• MalfunctionJul 10, 2025Material Split, Cut or Torn; Material 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 22474867 ↗
• MalfunctionJun 4, 2025Thermal Decomposition of Device; Unintended Movement; Thermal Decomposition of Device; Unintended Movement

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE 8MM PERMANENT CAUTERY SPATULA (PCS) INSTRUMENT WAS NOT FLEXIBLE IN THE WRIST ROTATION AND THE INSTRUMENT WIRE SLIPPED. 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 SURGEON WAS CUTTING THE UTERINE LIGAMENT WHEN THE ISSUE OCCURRED. THE FAILURE WAS RELATED TO AN INABILITY TO MOVE THE INSTRUMENT AT ALL, BEING THAT THE INSTRUMENT WAS NOT FLEXIBLE WHEN TURNING. A BLACK INSULATION ON THE CAUTERY CABLE WAS STRIPPED OR DAMAGED, AND AN EXPOSED WIRE WAS OBSERVED. THERE WAS A LOSS OF CAUTERY ASSOCIATED WITH THE BROKEN BLACK CABLE, AND THERE WERE SIGNS OF THERMAL DAMAGE AT THE SITE OF BREAKAGE, ALTHOUGH NO ARCING WAS OBSERVED DURING THE PROCEDURE. PROCEDURE DETAILS WERE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22145934 ↗
• MalfunctionMar 18, 2025Arcing; Arcing

  REFER TO H11 FOR FOLLOW-UP INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21636818 ↗
• InjuryMar 6, 2025Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED PERICARDIAL SURGICAL PROCEDURE, PART OF THE OF THE PERMANENT CAUTERY SPATULA INSTRUMENT TIP DETACHED AND FELL INTO THE PERICARDIUM OF THE PATIENT DURING PREPARATION. THE FRAGMENT WAS SUCCESSFULLY RETRIEVED USING TWEEZERS DURING THE SAME OPERATION, WITH ALL PERSONNEL PRESENT CONFIRMING ITS RETRIEVED. THE PROCEDURE WAS COMPLETED ROBOTICALLY USING A BACKUP PERMANENT CAUTERY SPATULA INSTRUMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21536445 ↗
• MalfunctionSep 14, 2024Material Fragmentation; Material Fragmentation

  REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20219417 ↗
• MalfunctionJul 20, 2024Break; Break

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE 8MM PERMANENT CAUTERY SPATULA TIP FRACTURED. THE USER COMPLETED THE PROCEDURE WITH USING A BACKUP PERMANENT CAUTERY SPATULA NO FURTHER ISSUE REPORTED. NO FRAGMENT FELL INSIDE THE PATIENT. NO KNOWN IMPACT OR PATIENT CONSEQUENCE WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19786080 ↗
• MalfunctionApr 30, 2024Thermal Decomposition of Device; Smoking; Thermal Decomposition of Device; Smoking

  REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19218082 ↗
• MalfunctionApr 6, 2024Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE PERMANENT CAUTERY SPATULA INSTRUMENT HAD A BROKEN CABLE. THE USER COMPLETED THE PROCEDURE WITH NO FURTHER ISSUE REPORTED. NO FRAGMENT FELL INSIDE THE PATIENT. NO KNOWN IMPACT OR PATIENT CONSEQUENCE WAS REPORTED. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE SITE AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT: THE INSTRUMENT WAS NOT INSPECTED PRIOR TO USE, TISSUE DISSECTION WAS BEING PERFORMED WHEN THE ISSUE OCCURRED. NO ISSUE REPORTED RELATED TO INSTRUMENT MOVEMENT. NO LOSS OF CAUTERY ASSOCIATED WITH BROKEN/LOOSE CABLE. THE INSTRUMENT DID NOT COLLIDE WITH ANY OTHER INSTRUMENT OR TOOL DURING THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19056528 ↗
• MalfunctionMar 27, 2024Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED MYOMECTOMY SURGICAL PROCEDURE, THE PERMANENT CAUTERY SPATULA 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 INSPECTED PRIOR TO USE WITH NO ISSUE. THE SURGEON WAS DISSECTING WHEN THE ISSUE OCCURRED. THE ISSUE WAS NOT RESOLVED TO OPENING/CLOSING OF THE GRIPS, LEFT/RIGHT (YAW) MOTION OF THE GRIPS, OR UP/DOWN (PITCH) MOTION OF THE WRIST. ONE CABLE WAS VISIBLY PROTRUDING FROM THE DISTAL END OF THE INSTRUMENT. THE PROTRUDING CABLE WAS NOT THE ONE THAT CONTROLS OPENING/CLOSING OF THE JAWS OR THAT CONTROLS UP/DOWN MOTION OF THE WRIST. THE SILVER CABLE WAS BROKEN. THERE WAS NO LOSS OF CAUTERY OR SIGN OF THERMAL DAMAGE. THE INSTRUMENT DID NOT COLLIDE WITH ANY OTHER INSTRUMENT OR TOOL DURING THE PROCEDURE. NO FRAGMENT FELL INTO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18984618 ↗
• MalfunctionJan 5, 2024Thermal Decomposition of Device; Thermal Decomposition of Device

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE PERMANENT CAUTERY SPATULA INSTRUMENT ALLEGEDLY HAD A BROKEN DRIVE LINE. THE USER COMPLETED THE PROCEDURE USING A BACKUP WITH NO FURTHER ISSUE REPORTED. NO FRAGMENT FELL INSIDE THE PATIENT. NO KNOWN IMPACT OR PATIENT CONSEQUENCE WAS REPORTED. 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 18450600 ↗
• MalfunctionJan 3, 2024Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED MYOMECTOMY SURGICAL PROCEDURE, THE PERMANENT CAUTERY SPATULA HAD A BROKEN WIRE. THE USER COMPLETED THE PROCEDURE WITH NO FURTHER ISSUE REPORTED. NO FRAGMENT FELL INSIDE THE PATIENT'S ANATOMY. 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 FOUND TO BE BROKEN. THE INSTRUMENT WAS NOT USED ON THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18433188 ↗
• MalfunctionSep 8, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED BENIGN HYSTERECTOMY SURGICAL PROCEDURE, THE CONNECTION CABLE OF THE PERMANENT CAUTERY SPATULA INSTRUMENT WAS BROKEN. THERE WAS NO REPORT OF ANY FRAGMENTS FALLING INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17709025 ↗
• MalfunctionSep 8, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE CONNECTION CABLE OF THE PERMANENT CAUTERY SPATULA INSTRUMENT WAS BROKEN. THE PROCEDURE WAS COMPLETED WITH NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17708995 ↗
• MalfunctionAug 16, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED MYOMECTOMY SURGICAL PROCEDURE, THE CONNECTION CABLE OF THE PERMANENT CAUTERY SPATULA INSTRUMENT WAS BROKEN. THERE WAS NO REPORT OF ANY FRAGMENTS FALLING INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17561709 ↗
• MalfunctionAug 16, 2023Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT AFTER A DA VINCI-ASSISTED BENIGN HYSTERECTOMY SURGICAL PROCEDURE, THE CUSTOMER OBSERVED THAT THE CONNECTION CABLE OF THE PERMANENT CAUTERY SPATULA INSTRUMENT WAS BROKEN. THERE WAS NO REPORT OF ANY FRAGMENTS FALLING INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITH A BACK-UP THIRD PARTY INSTRUMENT WITH NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17561672 ↗
• MalfunctionAug 16, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED MYOMECTOMY SURGICAL PROCEDURE, THE CONNECTION CABLE OF THE PERMANENT CAUTERY SPATULA INSTRUMENT WAS BROKEN. THERE WAS NO REPORT OF ANY FRAGMENTS FALLING INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. EVALUATION OF THE RETURNED DEVICE FOUND A BROKEN PITCH CABLE AT THE DISTAL END. INTUITIVE SURGICAL, INC. (ISI) HAS ATTEMPTED TO OBTAIN ADDITIONAL INFORMATION RELATED TO THE REPORTED EVENT. HOWEVER, AS OF THE DATE OF THIS REPORT, NO ADDITIONAL INFORMATION HAS BEEN PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17560090 ↗
• MalfunctionJun 11, 2023Break; Break

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED MYOMECTOMY SURGICAL PROCEDURE, THE PERMANENT CAUTERY SPATULA INSTRUMENT COULD NOT FUNCTION AT A CERTAIN ANGLE. THE PROCEDURE WAS COMPLETED WITH THE SAME PERMANENT CAUTERY SPATULA INSTRUMENT WITH NO REPORTED INJURY. THE CUSTOMER PROVIDED AN IMAGE OF THE PERMANENT CAUTERY SPATULA INSTRUMENT WITH NO OBVIOUS DAMAGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17102495 ↗
• MalfunctionJun 11, 2023Break; Break

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED MYOMECTOMY SURGICAL PROCEDURE, THERE WAS A STOPPING POINT WHEN THE ANGLE OF THE PERMANENT CAUTERY SPATULA INSTRUMENT CHANGES FROM 60 DEGREES ON THE LEFT TO 60 DEGREES ON THE RIGHT. THE INSTRUMENT WAS ALSO IDENTIFIED WITH A BROKEN CABLE. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17102494 ↗
• MalfunctionJun 11, 2023Break; Break

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED MYOMECTOMY SURGICAL PROCEDURE, THE PERMANENT CAUTERY SPATULA HAD A BROKEN WIRE. THE PROCEDURE WAS COMPLETED USING THE SAME PERMANENT CAUTERY SPATULA WITH NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17102492 ↗
• MalfunctionMay 27, 2023Break; Material Fragmentation; Detachment of Device or Device Component; Break; Material Fragmentation; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE CABLE WAS DAMAGED. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17015541 ↗