EndoWrist SP 430300Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00886874123843), received between Nov 5, 2025 and Feb 12, 2026 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Unintended Movement” (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.

• MalfunctionFeb 12, 2026Unintended System Motion

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED RADICAL EXTRAPERITONEAL PROSTATECTOMY WITHOUT LYMPHADENECTOMY SURGICAL PROCEDURE, NON-INTUITIVE MOTIONS OCCURRED ON AN INSTRUMENT (K10250918-0025) THAT WAS INSTALLED ON UNIVERSAL SURGICAL MANIPULATOR (USM) 2. A TECHNICAL SUPPORT ENGINEER (TSE) WAS CONTACTED BY THE CUSTOMER FOR TROUBLESHOOTING. THE TSE CHECKED THE SYSTEM LOGS AND FOUND SEVERAL ENGAGEMENT ERRORS RECORDED ON USM 2. THE TSE ASKED THE CUSTOMER TO RESEAT THE STERILE ADAPTER AND INSTRUMENT ON USM 2. THE CALLER STATED THAT THE ISSUE PERSISTED. THE TSE THEN ASKED THE CUSTOMER TO INSTALL A DIFFERENT INSTRUMENT ON USM 2. THE CALLER REPORTED THAT WITH A DIFFERENT INSTRUMENT THE ISSUE WAS RESOLVED. THE TSE ASKED THE CALLER TO RE-INSTALL THE AFFECTED INSTRUMENT ON USM 2. THE CALLER STATED THAT THE ISSUE REAPPEARED, CONFIRMING THAT THE PROBLEM WAS RELATED TO THE CADIERE FORCEPS INSTRUMENT. THE PROCEDURE WAS COMPLETING AS PLANNED WITH NO REPORTED INJURY.INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE SURGEON'S HEAD WAS INSIDE THE VIEWER AND THE ISSUE OCCURRED WHILE THE SURGEON WAS TRYING TO MANIPULATE INSTRUM

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24328478 ↗
• MalfunctionNov 5, 2025Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE CADIERE FORCEPS INSTRUMENT WOULD NOT FOLLOW COMMANDS PROPERLY WITH NO OTHER INFORMATION GIVEN, AND THE CUSTOMER WAS UNAWARE IF ANY TROUBLESHOOTING WAS DONE LIKE RE-ATTACHING THE DRAPE STERILE ADAPTOR. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. FOLLOW-UP WAS ATTEMPTED TO GATHER MORE INFORMATION, BUT THE CUSTOMER WAS NOT ABLE TO PROVIDE ANY ADDITIONAL DETAILS RELATED TO THE EVENT/INSTRUMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23482288 ↗