EndoWrist SP 430200Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00886874123478), received between Mar 11, 2026 and Jul 21, 2026 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Material Fragmentation” (1 report).

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryJul 21, 2026Material Fragmentation; Adverse Event Without Identified Device or Use Problem

  Refer to H11 for Follow-Up information.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Unspecified Tissue Injury

  MAUDE report 25899517 ↗
• MalfunctionMar 11, 2026Unintended Movement

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE 6MM NEEDLE DRIVER INSTRUMENT WAS NOT ARTICULATING PROPERLY. 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 ISSUE OCCURRED WHILE THE SURGEON WAS OPERATING INSIDE THE SURGEON CONSOLE¿S HIGH RESOLUTION STEREO VIEWER AND ATTEMPTING TO MANIPULATE INSTRUMENTS. ALTHOUGH THE MOVEMENT SCALED APPROPRIATELY AND THE TIMING WAS CORRECT, THE INSTRUMENT DID NOT MOVE IN THE INTENDED DIRECTION; THE SURGEON TRIED TO MOVE THE WRIST LEFT, BUT THE INSTRUMENT MOVED CIRCULARLY TO THE RIGHT. THIS PROBLEM WAS PERSISTENT THROUGHOUT THE PROCEDURE AND WAS RESOLVED BY REPLACING THE INSTRUMENT WITH A NEW NEEDLE DRIVER. THERE WAS NO SHAKINESS, FRICTION, OR PATIENT INJURY OBSERVED. PHOTOGRAPHIC IMAGES OR VIDEO RECORDINGS OF THE EVENT ARE AVAILABLE FOR REVIEW, AND THE ISSUE WAS NOTED WITHIN THE FIRST 45 MINUTES OF THE ROBOTIC START.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24576103 ↗