EndoWrist;daVinci Si 420003Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00886874111161), received between Nov 8, 2019 and May 27, 2023 — classified as 1 injury, 4 malfunctions.

The most frequently reported specific device problem is “Difficult to Open or Close” (2 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 27, 2023Difficult to Open or Close; Difficult to Open or Close

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE SMALL CLIP APPLIER INSTRUMENT WAS UNABLE TO PROPERLY CLAMP. THE PROCEDURE WAS COMPLETED USING A BACKUP INSTRUMENT WITH NO FURTHER ISSUE REPORTED. NO KNOWN IMPACT OR PATIENT CONSEQUENCE WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17015838 ↗
• MalfunctionMay 27, 2023Break; Break

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED URETEROPLASY SURGICAL PROCEDURE, THE TIP OF THE SMALL CLIP APPLIER INSTRUMENT BROKE. A BACKUP INSTRUMENT OF THE SAME KIND WAS USED TO COMPLETE THE PROCEDURE. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17015525 ↗
• MalfunctionMay 13, 2023Difficult to Open or Close; Difficult to Open or Close

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED CARDIAC SURGICAL PROCEDURE, THE SMALL CLIP APPLIER INSTRUMENT WOULD NOT CLIP. THE PROCEDURE WAS COMPLETED AS PLANNED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) OBTAINED THE FOLLOWING INFORMATION FROM THE CUSTOMER ABOUT THE COMPLAINT: THE ROBOTICS COORDINATOR (ROCO) REPORTED THAT THE CLIP WOULD NOT STAY ON A SMALL CLIP APPLIER INSTRUMENT. THE TIPS WERE OBSERVED TO BE ALIGNED AND WERE NOT BENT. THERE WAS NO INJURY TO THE PATIENT AND THE PROCEDURE WAS COMPLETED WITH A BACK-UP SMALL CLIP APPLIER INSTRUMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16928118 ↗
• MalfunctionJan 28, 2022Unintended System Motion; Unintended System Motion

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED GASTROSTOMY PROCEDURE, THE USER ALLEGED THAT THE SMALL CLIP APPLIER INSTRUMENT EXHIBITED NON-INTUITIVE MOVEMENT - ALLEGEDLY "IT BITES THE CLIP, IT WILL FLEX, AND THE TIP WILL BEND." TROUBLESHOOTING WAS PERFORMED BY REPLACEMENT OF THE INSTRUMENT TO THE BACKUP AND THIS RESOLVED THE ISSUE. 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 INSPECTED PRIOR TO USE AND NO DAMAGE OR ANYTHING OUT OF THE ORDINARY WAS IDENTIFIED. THE INSTRUMENT ALLEGEDLY MOVED IN A NON-INTUITIVE/UNEXPECTED WAY. THE ISSUE HAPPENED TWICE ON THE SAME PATIENT SIDE MANIPULATOR ARM AND WAS INTERMITTENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13389603 ↗
• InjuryNov 8, 2019Difficult to Remove; Difficult to Remove

  IT WAS INITIALLY REPORTED THAT DURING AN UNSPECIFIED DA VINCI-ASSISTED SURGICAL PROCEDURE, THE SURGEON ATTEMPTED TO PLACE A CLIP USING A SMALL CLIP APPLIER INSTRUMENT. IT WAS ALLEGED THAT A CLIP "CLUNG TO THE ONE SIDE" AND THE SURGICAL STAFF HAD TO REMOVE THE CLIP AND "A LITTLE" OF AN UNSPECIFIED VESSEL. ON 10/21/2019 AND 11/03/2019, INTUITIVE SURGICAL, INC. (ISI) OBTAINED THE FOLLOWING ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT: THE SURGICAL PROCEDURE WAS NOT RECORDED ON VIDEO. THE SMALL CLIP APPLIER INSTRUMENT WAS INSPECTED PRIOR TO USE AND NO ISSUES WERE IDENTIFIED. WHEN THE EVENT OCCURRED, A SINGLE CLIP WAS ¿SKEWED TO ONE SIDE¿ SO THE INSTRUMENT COULD NOT BE REMOVED. DUE TO THE ALLEGED ISSUE, A SMALL VESSEL ON THE MEDIAL SIDE WAS DAMAGED AND ¿A LITTLE¿ BLEEDING WAS OBSERVED. IN ADDITION, AS A RESULT OF THE ALLEGED ISSUE, A PORTION OF THE VESSEL WAS REMOVED. THE VESSEL WAS NOT INTENDED TO BE REMOVED AS PART OF THE PLANNED SURGICAL PROCEDURE. THE BLEEDING WAS CONTROLLED USING AN UNSPECIFIED BOVIE DEVICE. NO BLOOD TRANSFUSIONS WERE ADMINISTERED. THE VESSEL DID NOT REQUIRE ANY REPAIR. THE SURGICAL PROCEDURE WAS COMPLETED ROBOTICALLY USING A BACKUP INSTRUMENT. NO POST-OPERA

  Patient problems: Blood Loss; Injury

  MAUDE report 9296325 ↗