EndoWrist SP 430006Recalls & reported problems

Summary

The FDA's MAUDE database contains 28 adverse event reports that list this exact device (DI 00886874114308), received between May 6, 2023 and Sep 29, 2026 — classified as 1 injury, 27 malfunctions.

The most frequently reported specific device problem is “Unintended System Motion” (14 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 28 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 29, 2026Unintended System Motion

  It was reported that during a da Vinci-assisted surgical procedure, the Single Port (SP) Needle Driver instrument was not responding to the commands.The procedure was completed with no reported injury.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50928531 ↗
• MalfunctionSep 22, 2026No Apparent Adverse Event

  It was reported that the customer experienced an issue with a Single Port (SP) Needle Driver instrument. The customer reported event has no report of patient injury.

  Patient problems: Insufficient Information

  MAUDE report 50852389 ↗
• MalfunctionMay 13, 2026Unintended System Motion

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED PYELOPLASTY SURGICAL PROCEDURE, THE NEEDLE DRIVER INSTRUMENT WAS NOT TWISTING CORRECTLY. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER TO OBTAIN ADDITIONAL INFORMATION, HOWEVER, NO FURTHER DETAILS ARE AVAILABLE REGARDING THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25165277 ↗
• MalfunctionApr 1, 2026No Apparent Adverse Event

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, 6MM NEEDLE DRIVER INSTRUMENT WAS BROKEN. THE PROCEDURE WAS UNKNOWN WITH NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24759439 ↗
• MalfunctionMar 30, 2026Unintended Movement

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SIMPLE EXTRAPERITONEAL PROSTATECTOMY SURGICAL PROCEDURE, THE CUSTOMER REPORTED AN ISSUE WITH THE SYSTEM AND THE SINGLE PORT (SP) NEEDLE DRIVER INSTRUMENT WAS NOTED TO BE MOVING IN A DIRECTION OPPOSITE THAN INTENDED. THE CUSTOMER REPLACED IT FOR ANOTHER INSTRUMENT AND IT SEEMED TO HAVE FIXED THE ISSUE. THE SIMILAR ISSUE OCCURRED IN THE FOLLOWING CASE, AND THE SITE HAD TO REPLACE THE INSTRUMENT TWICE TO GET IT TO RETURN TO NORMAL. THE TECHNICAL SUPPORT ENGINEER (TSE) ATTEMPTED TO REVIEW THE LOGS BUT ONSITE WAS NOT AVAILABLE. THE TSE THEN RECOMMENDED RESEATING THE SCOPE TO TRY AND RESOLVE THE ISSUE. THE PROCEDURE WAS COMPLETING AS PLANNED WITH NO REPORTED INJURY.

  Patient problems: Insufficient Information

  MAUDE report 24735660 ↗
• MalfunctionMar 12, 2026Unintended System Motion

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED MALIGNANT HYSTERECTOMY SURGICAL PROCEDURE, THE SINGLE PORT (SP) NEEDLE DRIVER INSTRUMENT DID NOT MOVE PROPERLY, AND THE MOTION WAS NOT INTUITIVE. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24584796 ↗
• MalfunctionFeb 12, 2026Unintended System Motion

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE NEEDLE DRIVER INSTRUMENT WOULD NOT FOLLOW THE DIRECTION THE SURGEON WAS ATTEMPTING TO MANEUVER. 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 DID NOT REMAIN STATIC AND MOVED IN THE OPPOSITE DIRECTION OF THE INTENDED COMMAND; WHEN MOVEMENT TO THE RIGHT WAS INTENDED, THE INSTRUMENT INSTEAD MOVED TO THE LEFT. THERE WAS NO DELAY OR SHAKINESS OBSERVED, BUT THE MOVEMENT WAS PERSISTENTLY IN THE WRONG DIRECTION. THE TIMING OF INSTRUMENT MOVEMENT WAS APPROPRIATE, WITH NO LAG; HOWEVER, THE ISSUE REMAINED CONSISTENT THROUGHOUT USE. THE PROBLEM WAS RESOLVED BY CHANGING THE ARM, THOUGH DETAILS SUCH AS THE LOT NUMBER OF THE DRAPE WERE UNAVAILABLE, AS IT WAS DISPOSED OF. THERE WERE NO INJURIES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24329336 ↗
• MalfunctionJan 16, 2026Break

  REFER TO H11 FOR FOLLOW-UP INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24102291 ↗
• MalfunctionJan 6, 2026Unintended System Motion

  REFER TO H11 FOR FOLLOW-UP INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23980178 ↗
• MalfunctionJan 6, 2026Unintended System Motion

  REFER TO H11 FOR FOLLOW-UP INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23979750 ↗
• MalfunctionDec 31, 2025Unintended System Motion; Unintended System Motion

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE SP NEEDLE DRIVER INSTRUMENT MOVEMENTS DID NOT CORRESPOND TO THE CONSOLE SURGEON. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23935412 ↗
• MalfunctionDec 3, 2025Unintended Movement; Unintended Movement

  REFER TO H11 FOR FOLLOW-UP INFORMATION.

  Patient problems: Insufficient Information

  MAUDE report 23709931 ↗
• MalfunctionOct 21, 2025Unintended System Motion; Unintended System Motion

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23352635 ↗
• MalfunctionSep 2, 2025Unintended System Motion; Unintended System Motion

  REFER TO H11 FOR FOLLOW-UP INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22935521 ↗
• MalfunctionJul 7, 2025Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE NEEDLE DRIVE INSTRUMENT WAS OBSERVED TO NOT BE MOVING CORRECTLY WHEN IT WAS DOCKED. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22417742 ↗
• MalfunctionMay 30, 2025Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE SP NEEDLE DRIVER HAD AN ARTICULATION PROBLEM. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22117857 ↗
• InjuryMar 31, 2025Unintended System Motion; Unintended System Motion

  REFER TO H11 FOR FOLLOW-UP INFORMATION.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 21730270 ↗
• MalfunctionNov 2, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT PRIOR TO STARTING A DA VINCI-ASSISTED SURGICAL PROCEDURE THE NEEDLE DRIVER INSTRUMENT HAD A BROKEN WIRE POKING OUT. THE PROCEDURE WAS COMPLETED. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE CUSTOMER AND GATHERED THE FOLLOWING INFORMATION: THERE WAS NO PATIENT INJURY. THE PROCEDURE WAS COMPLETED ROBOTICALLY AS PLANNED. A REPLACEMENT SAME BACKUP INSTRUMENT WAS USED. THE ISSUE WAS IDENTIFIED BEFORE THE PROCEDURE START, NO PORTS WERE PLACED YET.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20593980 ↗
• MalfunctionJul 2, 2024Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED RADICAL EXTRAPERITONEAL PROSTATECTOMY WITHOUT LYMPHADENECTOMY SURGICAL PROCEDURE, THE NEEDLE DRIVER INSTRUMENT WAS NOT ARTICULATING PROPERLY. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19660811 ↗
• MalfunctionJun 26, 2024Break; Break

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED GENERAL SURGERY SURGICAL PROCEDURE, THE NEEDLE DRIVER INSTRUMENT WAS FOUND TO HAVE THE TIP BROKEN. 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 INSPECTED PRIOR TO USE, AND NO DAMAGE WAS FOUND. THE CUSTOMER INDICATED THAT THE INSTRUMENT TIP WAS FOUND BROKEN AND DETACHED. THE CUSTOMER IDENTIFIED THE BROKEN TIP RIGHT AFTER DOCKING THE INSTRUMENT INTO THE PATIENT. UPON REVIEWING THE VIDEO RECORDING, IT WAS CONFIRMED THAT THE TIP WAS ALREADY BROKEN BEFORE INSERTING THE INSTRUMENT. THERE WAS NO REPORT OF FRAGMENT(S) FALLING INSIDE THE PATIENT. THE INSTRUMENT DID NOT COLLIDE WITH ANY OTHER INSTRUMENTS OR OTHER HARD MATERIAL DURING THE SURGICAL PROCEDURE. THE PORT INCISION WAS NOT ENLARGED TO REMOVE THE INSTRUMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19611799 ↗
• MalfunctionJun 11, 2024Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED OVARIAN CYSTECTOMY SURGICAL PROCEDURE, THE SP NEEDLER DRIVER INSTRUMENT MOVED IN THE OPPOSITE DIRECTION. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) PERFORMED FOLLOW-UP AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE ISSUE OCCURRED WHEN THE SURGEON WAS ATTEMPTING TO MANIPULATE INSTRUMENTS WHILE THE SURGEON¿S HEAD WAS INSIDE THE SURGEON SIDE CONSOLE¿S HIGH-RESOLUTION STEREO VIEWER. NO SHAKINESS AND/OR FRICTION WAS EXPERIENCED/OBSERVED. THE ISSUE OCCURRED APPROXIMATELY 20 MINUTES BEFORE THE END OF THE PROCEDURE. THE REPORTER CONFIRMED THAT THE ISSUE WAS CONSISTENT. THE SURGEON WAS UNABLE TO RESOLVE THE ISSUE, SO THEY COMPLETED THE PROCEDURE AS IS. THERE WAS NO PATIENT INJURY. THE REPORTER WAS UNAWARE OF ANY INSTRUMENT-TO-INSTRUMENT OR SYSTEM ARM-TO-ARM INTERFERENCE. THE INSTRUMENT WAS INSPECTED BEFORE USE, AND NO DAMAGE WAS FOUND.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19515718 ↗
• MalfunctionMay 17, 2024Break; Break

  REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19338600 ↗
• MalfunctionApr 20, 2024Failure to Sense; Failure to Sense

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SACROCOLPOPEXY SURGICAL PROCEDURE, THE SINGLE PORT (SP) NEEDLE DRIVER INSTRUMENT DID NOT MOVE ACCORDING TO THE SURGEON DIRECTION FROM THE CONSOLE. THE CUSTOMER STATED THAT THEY HAVE HAD THE ISSUE BEFORE, AND THE UNIVERSAL SURGICAL MANIPULATOR (USM) WAS CHANGED. THE INSTRUMENT WAS SWITCHED TO ANOTHER USM, BUT THE SAME ISSUE OCCURRED. THE CUSTOMER OBTAINED AND INSTALLED A NEW NEEDLE DRIVER AND THE SURGEON WAS ABLE TO CONTINUE WITH THE SURGERY. THE SURGEON BELIEVED IT WAS AN ISSUE WITH THE NEEDLE DRIVER, NOT THE USM. THERE WAS NO REPORT OF PATIENT INJURY.

  Patient problems: Insufficient Information

  MAUDE report 19149912 ↗
• MalfunctionJan 2, 2024Unintended System Motion; Unintended System Motion

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED BENIGN HYSTERECTOMY SURGICAL PROCEDURE, THE NEEDLE DRIVER INSTRUMENT WAS MOVING IN THE OPPOSITE DIRECTION. THE INSTRUMENT WAS USED ON PATIENT SIDE MANIPULATOR (PSM) 3. AN INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) REVIEWED THE SYSTEM LOGS AND NOTED ERRORS 31009/23300 ON THE INSTRUMENT SENSOR MISSING ON PSM3 AND TOOL ENGAGEMENT FAILURE ON THE PSM 3, DISC 1 WAS NOT ENGAGED. THE TSE RECOMMENDED CUSTOMER TO RESEAT THE STERILE ADAPTER AND INSTRUMENT OR TRY A NEW INSTRUMENT. THE CUSTOMER STATED THAT THE SURGEON STARTED WORKING AGAIN AND IT SEEMED LIKE IT WAS WORKING AS EXPECTED AT THE TIME OF THE CALL. THE CUSTOMER LATER CALLED BACK AND STATED THAT THEY REPLACED THE INSTRUMENT WITH NO CHANGE. THE TSE SUGGESTED TO RESEAT STERILE ADAPTER WHICH CUSTOMER PERFORMED WITH NO CHANGE. THE CUSTOMER CONFIRMED THAT IT WAS BETTER AFTER INSTRUMENT REPLACEMENT. THE PROCEDURE WAS COMPLETED WITH NO REPORTS OF PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18428695 ↗
• MalfunctionJun 17, 2023Unintended System Motion; Unintended System Motion

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE NEEDLE DRIVER DID NOT FUNCTION CORRECTLY. THE SCRUB TECHNICIAN STATED THAT THE ARM DID NOT FUNCTION CORRECTLY. THERE WAS AN NON-INTUITIVE MOVEMENT AND GRIP WITH THE INSTRUMENT. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE CUSTOMER TO CONFIRM THAT THE ISSUE OCCURRED WITH THE SURGEON CONSOLE¿S HIGH RESOLUTION STEREO VIEWER. THE SURGEON WAS ATTEMPTING TO MANIPULATE INSTRUMENTS FROM THE SURGEON CONSOLE. THERE WAS NO INSTRUMENT COLLISION OR ARM INTERFERENCE. A PEEL PACKED INSTRUMENT WAS USED TO RESOLVE THE ISSUE. NO DRAPE INFORMATION WAS RECORDED. NO UNUSUAL DAMAGE WAS FOUND.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17149077 ↗