EndoWrist;daVinci Si 420327Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00886874111826), received between Jul 21, 2020 and Sep 15, 2025 — classified as 2 injuries, 8 malfunctions.

The most frequently reported specific device problem is “Difficult to Open or Close” (8 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. Jul 1, 2022Class IIOpen, Classified

   Due to the potential for unexpected motion caused by the partial disengagement of the instrument from the system.

   Z-1459-2022 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 15, 2025Difficult to Open or Close; Difficult to Open or Close

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED CHOLECYSTECTOMY SURGICAL PROCEDURE, THE MEDIUM-LARGE CLIP APPLIER INSTRUMENT'S CLIPS WERE NOT GETTING APPLIED THROUGH THE INSTRUMENT. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23058607 ↗
• MalfunctionMay 13, 2023Difficult to Open or Close; Difficult to Open or Close

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED UMBILICAL HERNIA REPAIR SURGICAL PROCEDURE, THE MEDIUM-LARGE CLIP APPLIER INSTRUMENT WAS FOUND TO HAVE THE JAWS WOULD NOT CLOSE. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16926984 ↗
• MalfunctionMay 13, 2023Difficult to Open or Close; Difficult to Open or Close

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED NEPHRECTOMY SURGICAL PROCEDURE, THE MEDIUM-LARGE CLIP INSTRUMENT COULDN'T ENGAGE WHEN GRASPING THE VESSEL ON THE SECOND TRIAL. THE PROCEDURE WAS COMPLETED WITH A BACKUP INSTRUMENT AND COMPLETED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE OR NURSE AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: A WECK HEM-O-LOK MEDIUM-LARGE CLIP APPLIER WAS USED WITH A GREEN CARTRIDGE. THE USER WAS ABLE TO MOVE THE INSTRUMENT AROUND. THE INSTRUMENT DID NOT MISAPPLY THE CLIP. THE SURGEON CONFIRMED CLOSURE OF THE CLIP AFTER LIGATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16926920 ↗
• MalfunctionMay 13, 2023Difficult to Open or Close; Difficult to Open or Close

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE CLIP WAS NOT CLOSING PROPERLY ON A MEDIUM-LARGE CLIP APPLIER INSTRUMENT. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. FOLLOW-UP COMPLETED ON (B)(6) 2020 WITH ROBOTICS COORDINATOR AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION ABOUT THE COMPLAINT: THE MEDIUM-LARGE CLIP APPLIER INSTRUMENT NEVER WORKED SO THE SURGEON WENT TO A BACKUP INSTRUMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16926881 ↗
• MalfunctionMay 13, 2023Difficult to Open or Close; Difficult to Open or Close

  IT WAS REPORTED, THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE. THE CLIP APPLIER INSTRUMENT WOULD NOT CLOSE PROPERLY. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16926857 ↗
• InjuryMay 13, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE MEDIUM-LARGE CLIP APPLIER WOULD NOT APPLY THE CLIP. THE CLIP FELL FROM INSIDE THE PATIENT'S ANATOMY AND WAS RETRIEVED DURING THE SAME PROCEDURE. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE ROBOTIC COORDINATOR AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE CUSTOMER REPORTED THAT THE INSTRUMENT WAS INSPECTED PRIOR TO USE. AT THE TIME, THE SURGEON DID NOT OBSERVE ANY ISSUES WITH THE MEDIUM-LARGE CLIP APPLIER INSTRUMENT. NO COLLISIONS WERE OBSERVED. IT WAS CONFIRMED THE CLIP WAS RETRIEVED DURING THE SAME PROCEDURE WITH NO ADDITIONAL PROCEDURES REQUIRED. WHEN THE INSTRUMENT WAS REMOVED, THE WRIST WAS STRAIGHTENED AND NO RESISTANCE WAS NOTICED. THERE WAS NO DAMAGE OBSERVED ON THE INSTRUMENT AFTER THE REPORTED ISSUE. POST-OPERATIVE TESTS LIKE X-RAYS AND ULTRA SOUNDS WERE NOT PERFORMED. A BACKUP CLIP APPLIER INSTRUMENT WAS USED TO CONTINUE AND THE PROCEDURE WAS COMPLETED ROBOTICALLY WITH NO REPORTED INJURY OR HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16925199 ↗
• MalfunctionApr 18, 2023Difficult to Open or Close; Material Deformation; Difficult to Open or Close; Material Deformation

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED RIGHT HEMICOLECTOMY SURGICAL PROCEDURE, THE CUSTOMER REPORTED THAT THE MEDIUM-LARGE CLIP APPLIER (MLCA) DID NOT RELEASE THE CLIP PROPERLY AFTER IT WAS FIRED. THE MLCA INSTRUMENT WAS REMOVED, AND THE CUSTOMER FOUND THAT THAT THE JAW OF THE INSTRUMENT WAS DEFORMED. 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 NOT INSPECTED PRIOR TO USE. THE CUSTOMER DID NOT NOTICE THE DEFORMATION ISSUE BEFORE USE. THE CUSTOMER WAS USED MEDIUM-LARGE HEM-O-LOK CLIP. THE CLIP COULD NOT BE SUCCESSFULLY RELEASED FROM THE JAWS OF THE CLIP APPLIER. THE ISSUE OCCURRED IN THE FIRST FIRE OF THE CLIP APPLIER. THE TISSUE WAS NOT GREATER THAN 10 MM. THE CUSTOMER USED A BACKUP MLCA INSTRUMENT TO CONTINUE WITH THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16765903 ↗
• InjurySep 30, 2022Difficult to Open or Close; Inadequate Lubrication; Difficult to Open or Close; Inadequate Lubrication

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE MEDIUM-LARGE CLIP APPLIER (MLCA) INSTRUMENT COULD NOT CLIP DUE TO POOR ENGAGEMENT ISSUE. 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 MLCA WAS INSPECTED VISUALLY WITH NO ANOMALY OR DAMAGE. THE ISSUE OCCURRED INSIDE THE PATIENT¿S ANATOMY. THE MLCA WAS ABLE TO RETAIN THE CLIP, BUT IT FAILED TO APPLY THE CLIP. AFTER THE FAILURE, THE SURGEON TRIED TO REMOVE THE CLIP, BUT THE CLIP WAS CAUGHT TO THE TISSUE AND FELL INTO THE PATIENT ANATOMY. EVENTUALLY, THE CLIP COULD BE RETRIEVED IN THE SAME PROCEDURE. THERE WAS NO PATIENT¿S INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15515202 ↗
• MalfunctionSep 28, 2020Difficult to Open or Close; Difficult to Open or Close

  REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.

  Patient problems: Blood Loss

  MAUDE report 10591653 ↗
• MalfunctionJul 21, 2020Break; Break

  IT WAS REPORTED THAT DURING CENTRAL PROCESSING, THE CLIP APPLIER WAS FOUND TO HAVE A FRAYED CABLE. THERE WAS NO PATIENT INVOLVEMENT REPORTED. INTUITIVE SURGICAL, INC., FOLLOWED UP WITH THE REPORTER TO ATTEMPT TO CONFIRM THE EVENT DATE AND ADDITIONAL INFORMATION. NO FURTHER DETAILS HAVE BEEN PROVIDED AS OF THE DATE OF THIS REPORT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10305921 ↗