EndoWrist SP 430005Recalls & reported problems

Summary

The FDA's MAUDE database contains 26 adverse event reports that list this exact device (DI 00886874114292), received between May 6, 2022 and Aug 21, 2026 — classified as 4 injuries, 22 malfunctions.

The most frequently reported specific device problem is “Difficult to Open or Close” (19 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 26 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 21, 2026Difficult to Open or Close

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50382292 ↗
• MalfunctionMay 28, 2026Break

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, A PIECE OF THE BOTTOM PLATE FELL OUT OFF OF THE INSTRUMENT WHEN TAKING OUT OF STERILE WRAPPER. THE INSTRUMENT WAS REMOVED AND REPLACED WITH NEW INSTRUMENT. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25324273 ↗
• InjuryMar 9, 2026Material Separation; Difficult to Open or Close

  REFER TO H11 FOR FOLLOW-UP INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24545262 ↗
• MalfunctionFeb 27, 2026Unintended System Motion

  REFER TO H11 FOR FOLLOW-UP INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24470519 ↗
• MalfunctionFeb 24, 2026Difficult to Open or Close

  REFER TO H11 FOR FOLLOW-UP INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24426268 ↗
• MalfunctionJan 22, 2026Difficult to Open or Close

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE MEDIUM-LARGE CLIP APPLIER DOES NOT CLIP. THE USER COMPLETED THE PROCEDURE WITH 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 24142031 ↗
• MalfunctionJan 5, 2026Difficult to Open or Close

  REFER TO H11 FOR FOLLOW-UP INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23969027 ↗
• MalfunctionDec 29, 2025Difficult to Open or Close; Difficult to Open or Close

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE MEDIUM-LARGE CLIP APPLIER INSTRUMENT WAS NOT OPENING OR RELEASING CORRECTLY. THE USER COMPLETED THE PROCEDURE WITH 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 23917824 ↗
• MalfunctionDec 3, 2025Difficult to Open or Close; Difficult to Open or Close

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED RETROPERITONEAL NEPHRECTOMY PROCEDURE, THE MEDIUM-LARGE CLIP APPLIER INSTRUMENT CLOSED AND APPLIED A CLIP TO THE RENAL ARTERY BUT BECAME STUCK ON THE VESSEL. THE CUSTOMER REPORTED THAT THE RELEASE WHEEL DID NOT WORK TO OPEN THE JAWS. THE CUSTOMER WAS ABLE TO GET IT OFF THE VESSEL AND THE PROCEDURE WAS COMPLETED AS PLANNED WITH NO REPORTED PATIENT INJURY OR COMPLICATION. THE INSTRUMENT WAS INSPECTED AFTER THIS EVENT OCCURRED AND THE CUSTOMER DID NOT OBSERVE ANY DAMAGE OR ISSUES OTHER THAN THE WHEEL AT THE BACK OF THE INSTRUMENT TO OPEN THE INSTRUMENT JAWS DID NOT MOVE WHEN MANIPULATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23703848 ↗
• MalfunctionDec 2, 2025Difficult to Open or Close; Difficult to Open or Close

  REFER TO H11 FOR FOLLOW-UP INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23698875 ↗
• InjuryNov 19, 2025Difficult to Open or Close; Difficult to Open or Close

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED THYMECTOMY SURGICAL PROCEDURE, THE MEDIUM-LARGE CLIP APPLIER BECAME STUCK ON THE ARTERY. THE E-STOP WAS PRESSED, AND THE RELEASE KNOB ON THE INSTRUMENT WAS TRIED WITH NO CHANGE. THE TECHNICAL SERVICE ENGINEER (TSE) RECOMMENDED THE CUSTOMER TO USE THE INSTRUMENT DISENGAGEMENT BUTTON TO RELEASE THE MOTOR PACK AND THEN TRY TO OPEN THE JAWS. ADDITIONAL PORTS WERE PLACED TO ASSIST WITH THE ATTEMPT TO REMOVE THE INSTRUMENT. THE SURGEON WAS ABLE TO REMOVE THE INSTRUMENT BY MOVING THE CLIP ENOUGH USING THE TIP OF A LAPAROSCOPIC STAPLER. BLOOD LOSS WAS MINIMAL DUE TO PLACING ADDITIONAL PORTS IN THE PATIENT'S CHEST. THERE WAS NO DAMAGE TO THE ARTERY. THE PROCEDURE WAS COMPLETED ROBOTICALLY.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 23595028 ↗
• MalfunctionSep 16, 2025Material Integrity Problem; Material Integrity Problem

  REFER TO H11 FOR FOLLOW-UP INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23060231 ↗
• MalfunctionJul 24, 2025Difficult to Open or Close; Difficult to Open or Close

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE MEDIUM-LARGE CLIP APPLIER INSTRUMENT DID NOT CLOSE. THE USER COMPLETED THE PROCEDURE USING A DIFFERENT BACKUP MEDIUM-LARGE CLIP APPLIER WITH 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 22584619 ↗
• MalfunctionJul 14, 2025Difficult to Open or Close; Difficult to Open or Close

  REFER TO H11 FOR FOLLOW-UP INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22501895 ↗
• MalfunctionJun 25, 2025Unintended System Motion; Unintended System Motion

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE MOVEMENT OF THE SINGLE PORT MEDIUM-LARGE CLIP APPLIER INSTRUMENT DIFFERED FROM THE COMMANDS OF THE USER. IT WAS DIFFICULT TO CLIP AT THE EXACT LOCATION. USE OF THE INSTRUMENT WAS DISCONTINUED, AND IT WAS REPLACED TO THE BACKUP. THE USER COMPLETED THE PROCEDURE, AND NO KNOWN IMPACT OR PATIENT CONSEQUENCE WAS REPORTED. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THERE WAS NO PATIENT HARM/INJURY. A FRAGMENT DID NOT FALL INSIDE OF THE PATIENT¿S ANATOMY. THE ISSUE OCCURRED WITH THE SURGEON¿S HEAD INSIDE THE SURGEON CONSOLE¿S HIGH RESOLUTION STEREO VIEWER. THE ISSUE OCCURRED WHILE THE SURGEON WAS ATTEMPTING TO MANIPULATE INSTRUMENTS FROM THE SURGEON CONSOLE. THE FAILURE WAS NOT RELATED TO AN INABILITY TO MOVE THE INSTRUMENT AT ALL. THE MOVEMENTS OF THE SURGEON DID NOT SCALE APPROPRIATELY TO THE INSTRUMENT. THE INSTRUMENT DID NOT MOVE IN THE INTENDED DIRECTION. THE TIMING OF INSTRUMENT MOVEMENT WAS APPROPRIATE. THERE WAS NOT ANY SHAKINESS AND/OR FRICTION EXPERIENCED/OBSERVED. THERE WAS NOT ANY INSTRUMENT-TO-INSTRUMENT OR SYSTEM ARM-TO-ARM INTE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22333599 ↗
• MalfunctionJun 23, 2025Difficult to Open or Close; Difficult to Open or Close

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED PARTIAL NEPHRECTOMY - RETROPERITONEAL ANTERIOR SURGICAL PROCEDURE, THE SINGLE PORT MEDIUM-LARGE CLIP APPLIER WOULD NOT OPEN; THE CLIP COULD BE LOADED BUT COULD NOT CLIP INTO THE PATIENT. THEN, THE SINGLE PORT MEDIUM-LARGE CLIP APPLIER WOULD NOT OPEN AND COULD ONLY BE OPENED MANUALLY. NO FRAGMENT FELL INTO THE PATIENT. THE USER COMPLETED THE PROCEDURE, AND NO KNOWN IMPACT OR PATIENT CONSEQUENCE WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22310944 ↗
• MalfunctionMay 30, 2025Difficult to Open or Close; Difficult to Open or Close

  REFER TO H11 FOR FOLLOW-UP INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22111976 ↗
• MalfunctionMay 21, 2025Difficult to Open or Close; Difficult to Open or Close

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE SINGLE PORT MEDIUM-LARGE CLIP APPLIER INSTRUMENT FAILED TO DEPLOY THE CLIP. THE USER COMPLETED THE PROCEDURE AND NO KNOWN IMPACT OR PATIENT CONSEQUENCE WAS REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 22065783 ↗
• MalfunctionMar 12, 2025Unintended System Motion; Unintended System Motion

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED BENIGN HYSTERECTOMY SURGICAL PROCEDURE, THE SINGLE PORT (SP) MEDIUM-LARGE CLIP APPLIER INSTRUMENT WAS NOT RESPONDING CORRECTLY. THE SURGEON DESCRIBED THE ISSUE AS THE ARM WAS DRIFTING ON. NO FRAGMENT FELL INTO THE PATIENT. THE USER COMPLETED THE PROCEDURE, AND 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 MEDIUM-LARGE CLIP APPLIER INSTRUMENT WAS NOT RESPONDING CORRECTLY, AND THE SURGEON USED THE TERM DRIFTING TO DESCRIBE THE INCORRECT ACTION. THE INCIDENT DID NOT AFFECT THE OUTCOME OF THE PROCEDURE, AND THE PROCEDURE WAS COMPLETED WITHOUT INCIDENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21586658 ↗
• MalfunctionDec 1, 2023Difficult to Open or Close; Difficult to Open or Close

  REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18249807 ↗
• InjuryNov 15, 2023Detachment of Device or Device Component; Difficult to Open or Close; Detachment of Device or Device Component; Difficult to Open or Close

  REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.

  Patient problems: Foreign Body In Patient

  MAUDE report 18141205 ↗
• MalfunctionJul 21, 2023Difficult to Open or Close; Difficult to Open or Close

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE MEDIUM-LARGE CLIP APPLIER FAILED TO CLIP. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THERE WAS ONLY ONE SP MEDIUM-LARGE CLIP APPLIER. THE ISSUE WAS FROM A CLINICAL TRIAL FROM 8 OR 9 MONTHS AGO. NO FURTHER INFORMATION WAS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17372127 ↗
• MalfunctionJun 20, 2023Difficult to Open or Close; Difficult to Open or Close

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED THYMECTOMY SURGICAL PROCEDURE, 2 CLIP APPLIER INSTRUMENTS WERE NOT SAFELY RELEASING THE CLOSED MEDIUM LARGE HEM-O-LOK-CLIPS AFTER CLIPPING THE THYMIC VEIN. ADDITIONAL MANEUVERS WERE REQUIRED TO RELEASE THE INSTRUMENT FROM THE CLIP. THIS HAPPENED FOR 2 DIFFERENT CLIP APPLIER INSTRUMENTS AND EVERY TIME THE CLIP WAS APPLIED TO A VESSEL. THE SURGEON EXPRESSED THAT THIS WAS A SERIOUS CONCERN. THERE WERE ALSO EXTENSIVE GLARE ON DISPLAY FOR THE SURGICAL IMAGE DURING THE SUPERIOR DISSECTION OF THE UPPER THYMUS. THE SURGEON TRIED TO CORRECT THIS BY ADJUSTING THE SHARPNESS AND BRIGHTNESS OF THE IMAGE. IT IMPROVED BUT DID NOT GO AWAY. 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 CLIP APPLIER INSTRUMENT WAS INSPECTED PRIOR TO USE WITH NO ABNORMALITIES IDENTIFIED AND WAS BEING USED THE FIRST TIME. THE INSTRUMENT WAS USED 3 TIMES WITHIN THE PROCEDURE AND THE ISSUE OCCURRED EVERY TIME. THE SURGEON CONTINUED WITH THE SAME CLIP APPLIER INSTRUMENT AND COMPLETED THE PROCEDURE. THERE WERE NO ADVERSE EVENT ASSOCIATED WITH THI

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17167689 ↗
• MalfunctionMar 24, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED THYROIDECTOMY SURGICAL PROCEDURE, THE SINGLE-PORT MEDIUM-LARGE CLIP APPLIER INSTRUMENT WAS FOUND TO HAVE BROKEN CABLES. THERE WAS NO REPORT THAT THE INSTRUMENT HAD CLIP APPLICATION ISSUES. A BACKUP INSTRUMENT OF THE SAME KIND WAS USED TO CONTINUE THE PROCEDURE. THERE WAS NO REPORT OF FRAGMENT(S) FALLING INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITH NO REPORT OF PATIENT 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 ABNORMALITY. NO FUNCTIONAL ISSUE ON THE CLIP APPLIER INSTRUMENT REPORTED DURING INTRAOPERATIVE USE. THE CUSTOMER CONFIRMED THAT NO FRAGMENT FELL INSIDE OF THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16616322 ↗
• MalfunctionJun 23, 2022Difficult to Open or Close; Difficult to Open or Close

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED THYROIDECTOMY SURGICAL PROCEDURE, THE JAW OF THE MEDIUM-LARGE CLIP APPLIER INSTRUMENT WOULD NOT OPEN. A BACKUP INSTRUMENT OF THE SAME KIND WAS USED TO CONTINUE THE PROCEDURE. THERE WAS NO REPORT OF FRAGMENT(S) FALLING INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITH NO REPORT OF PATIENT 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 ABNORMALITY. THE INSTRUMENT JAWS WERE NOT OPENED BUT WERE NOT GRASPING THE TISSUE SO THE CUSTOMER DID NOT USE THE INSTRUMENT RELEASE KEY (IRK). THE INSTRUMENT WAS IN USED FOR VESSEL LIGATION AND REMOVED WITH NO ISSUE. THE VESSEL WAS LESS THAN 10 MM IN DIAMETER. THE SURGEON DID NOT ENCOUNTER ANY OBSTRUCTIONS SUCH AS CLIPS, STAPLES, OR OTHER HARD MATERIAL BETWEEN THE INSTRUMENT JAWS. THE PATIENT HAD NO INJURY/HARM. THE CUSTOMER CONFIRMED THAT THE MEDIUM-LARGE CLIP WAS USED AND NO FRAGMENT FELL INSIDE OF THE PATIENT. THERE WAS NO UNEXPECTED TISSUE REMOVAL NOR BLEEDING. PHOTOGRAPHIC IMAGES OF THE DEVICE(S) OR A VIDEO RECORDING OF THE PROCEDURE WERE NOT AVAILABLE FOR ISI REVIEW.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14785065 ↗