EndoWrist 480299Recalls & reported problems

Summary

The FDA's MAUDE database contains 158 adverse event reports that list this exact device (DI 00886874114810), received between Apr 9, 2018 and Sep 26, 2026 — classified as 55 injuries, 102 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (62 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 16, 2026.

Recalls naming this device

1. Jun 4, 2018Class IIOpen, Classified

   The firm has identified the potential for a silicone particle to be generated within the Suction Irrigator device. If generated, a particle may be introduced into the patient with irrigation.

   Z-0249-2020 · Root cause: Process change control · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 158 reports, in the reporter's own words as published by the FDA.

• OtherSep 26, 2026Material Fragmentation

  Patient problems: Foreign Body In Patient

  MAUDE report 50906400 ↗
• InjurySep 25, 2026Material Fragmentation

  It was reported that during a da Vinci-assisted procedure, the tip of the Suction Irrigator instrument broke off, and a fragment fell into the patient's anatomy. The fragment was successfully retrieved during the same procedure. A backup instrument was used to complete the procedure, and no patient injury was reported. No additional procedure was required.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50900570 ↗
• MalfunctionAug 12, 2026Suction Problem

  It was reported during a da Vinci assisted surgical procedure that a Suction Irrigator was unable to irrigate and use suction. The procedure was completed with no reported injury.Intuitive Surgical, Inc. (ISI) followed up with the initial reporter and obtained the following additional information: No fragments fell into the patient. There was no concern if any fragments fell into the patient because it failed before use. The customer confirmed that no damage or missing material occurred during the surgical procedure.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50218081 ↗
• MalfunctionAug 7, 2026Difficult to Remove

  It was reported that during da Vinci-assisted Hysterectomy - Benign surgical procedure, the customer contacted Intuitive Technical Support Engineer (TSE) to report an issue where the Suction Irrigator instrument was getting stuck when being removed and had to rip it apart to fully remove from the cannula. There was no issue with the system during this event. The procedure was completed with no reported injury.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50183307 ↗
• MalfunctionMay 18, 2026Break

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE THAT A METAL PIECE BROKE OFF OF THE SUCTION IRRIGATOR INSTRUMENT BROKE AND BECAME STUCK INSIDE OF THE 8MM PORT. THE PROCEDURE WAS COMPLETED WITH NO REPORTS OF PATIENT INJURY, NOR OF FRAGMENTS FALLING INTO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25210595 ↗
• MalfunctionMay 18, 2026Material Split, Cut or Torn

  IT WAS REPORTED THAT THERE WAS A BROKEN CABLE WITH A DA VINCI PRODUCT. THE CUSTOMER REPORTED EVENT HAS NO REPORT OF PATIENT INJURY.

  Patient problems: Insufficient Information

  MAUDE report 25210594 ↗
• MalfunctionMay 4, 2026No Device Output

  IT WAS REPORTED THAT THE CUSTOMER EXPERIENCED AN ISSUE WITH AN INTUITIVE PRODUCT. THE CUSTOMER REPORTED EVENT HAS NO REPORT OF PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25074349 ↗
• MalfunctionMay 4, 2026Suction Problem

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED ENDOMETRIOSIS RESECTION SURGICAL PROCEDURE, THE CUSTOMER REPORTED THAT THE SUCTION IRRIGATOR (SI) INSTRUMENT IRRIGATION BUTTON WOULD NOT PRESS, AND THE SUCTION FUNCTION KEPT RUNNING, WHICH REMOVED PNEUMOPERITONEUM. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25072571 ↗
• MalfunctionApr 20, 2026

  DURING THE SURGERY, THE SUCTION IRRIGATOR STOPPED FUNCTIONING. IT WAS REPLACED WITH ANOTHER INSTRUMENT, AND THE NEW SUCTION IRRIGATOR WAS NOT ENGAGING. THE ROBOT WAS GIVING AN ERROR MESSAGE. THE NEXT SUCTION IRRIGATOR USED WAS FUNCTIONING NORMALLY. NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24924855 ↗
• MalfunctionApr 17, 2026Suction Problem

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE SURGEON AND STAFF COULD NOT DEACTIVATE SUCTION. THE CUSTOMER REPORTED THERE WAS A LOSS ALL PNEUMO DURING THE PROCEDURE. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24906472 ↗
• MalfunctionMar 24, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT THE PIECE OF SUCTION IRRIGATOR THAT ATTACHES TO THE INTELLICART FELL OFF WHILE THE NURSE WAS TRYING TO ATTACH IT. NO KNOWN IMPACT OR PATIENT CONSEQUENCE WAS REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 24677180 ↗
• MalfunctionMar 11, 2026Unintended System Motion

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE SUCTION IRRIGATOR INSTRUMENT WOULD NOT ARTICULATE. THE SURGEON HAD NO CONTROL OF IT FROM THE ROBOT. 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 24571636 ↗
• MalfunctionMar 10, 2026Suction Problem; Gas/Air Leak

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE SUCTION IRRIGATOR WOULD NOT STOP THE SUCTION FUNCTION, RESULTING IN LOSS OF PNEUMOPERITONEUM. 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24563643 ↗
• MalfunctionMar 7, 2026Break; Difficult to Remove

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED BENIGN HYSTERECTOMY SURGICAL PROCEDURE, AN INTUITIVE SURGICAL, INC. (ISI) CLINICAL SALES REPRESENTATIVE (CSR) CONTACTED AN ISI TECHNICAL SUPPORT ENGINEER (TSE) FROM OFFSITE OR OUT OF THE ROOM AND DID A 3-WAY CALL WITH THE OPERATING ROOM (OR) STAFF WHO REPORTED THAT THE SUCTION IRRIGATOR INSTRUMENT WAS STUCK ON THE ARM. THE CUSTOMER STATED THAT THEY HAD UNDOCKED THE WHOLE ARM AND TROCAR FROM THE PATIENT. THE CUSTOMER THEN EXPLAINED THAT IT LOOKED LIKE THE TIP OF THE SUCTION IRRIGATOR INSTRUMENT WAS BROKEN AND GETTING STUCK IN THE TROCAR. THE CUSTOMER STATED THAT THEY WERE GOING TO WORK ON GETTING THE INSTRUMENT TIP OUT OF THE TROCAR, BUT THEY WERE PROCEEDING WITH THE CASE. THE CUSTOMER ENDED THE CALL. THE PROCEDURE WAS COMPLETING AS PLANNED WITH NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24540059 ↗
• MalfunctionMar 6, 2026

  CONDENSATION WAS NOTICED IN THE TUBING OF THE SUCTION IRRIGATOR WHILE IT WAS STILL IN THE PACKAGING, PRIOR TO OPENING. A NEW SUCTION IRRIGATOR WAS RETRIEVED, THE CONTAMINATED ONE DID NOT COME IN CONTACT WITH THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24532242 ↗
• MalfunctionMar 3, 2026No Apparent Adverse Event

  IT WAS REPORTED THAT THE CUSTOMER EXPERIENCED AN ISSUE WITH A SUCTION IRRIGATOR. THE CUSTOMER REPORTED EVENT HAS NO REPORT OF PATIENT INJURY. AT THE TIME OF THIS REPORT IT UNKNOWN HOW THE PROCEDURE WAS COMPLETED. THERE WAS NO REPORTED INJURY. ON 02/06/2026, INTUITIVE SURGICAL, INC. (ISI) RECEIVED USER FACILITY REPORT 0301220000-2026-8002 STATING: ROBOT SUCTION IRRIGATOR BROKE WHILE INSIDE THE PATIENT. SCRUB AND PHYSICIAN ASSISTANT (PA) WERE UNABLE TO REMOVE SUCTION IRRIGATOR FROM TROCAR. ENTIRE TROCAR WITH SUCTION IRRIGATOR STUCK INSIDE HAD TO BE REMOVED FROM THE PATIENT. TROCAR AND SUCTION IRRIGATOR WERE BOTH REPLACED.

  Patient problems: Insufficient Information

  MAUDE report 24492942 ↗
• MalfunctionMar 2, 2026Break

  REFER TO H11 FOR FOLLOW-UP INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24478465 ↗
• InjuryFeb 23, 2026Break; Insufficient Device Problem Information

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED CHOLECYSTECTOMY AND ISOLATED LYSIS OF ADHESIONS PROCEDURE, THE LIVER WAS INADVERTENTLY LACERATED WHILE USING THE SUCTION IRRIGATOR INSTRUMENT. SUBSEQUENT INSPECTION REVEALED DAMAGE TO THE INSTRUMENT¿S TIP. IT IS UNCLEAR WHETHER THE SUCTION IRRIGATOR INSTRUMENT WAS DEFECTIVE PRIOR TO THE PROCEDURE OR IF THE DAMAGE OCCURRED INTRAOPERATIVELY. THE FOLLOWING DETAILS REMAIN UNKNOWN: HOW THE INSTRUMENT WAS DAMAGED, WHETHER THE LACERATION LED TO BLEEDING, AND WHETHER ANY ADDITIONAL MEDICAL INTERVENTIONS WERE REQUIRED. ADDITIONAL INFORMATION HAS BEEN REQUESTED; HOWEVER, NO RESPONSE HAS BEEN RECEIVED.

  Patient problems: Insufficient Information; Liver Laceration(s)

  MAUDE report 24423884 ↗
• MalfunctionFeb 6, 2026Difficult to Remove

  REFER TO H11 FOR FOLLOW-UP INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24275610 ↗
• MalfunctionFeb 2, 2026Break; Difficult to Remove

  REFER TO H11 FOR FOLLOW-UP INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24241339 ↗
• InjuryFeb 2, 2026Suction Problem

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED CHOLECYSTECTOMY PROCEDURE, THE SUCTION IRRIGATOR BUTTON GOT STUCK WHILE SUCTIONING BLOOD AND THE CUSTOMER WAS LOSING PNEUMOPERITONEUM. THE SUCTION IRRIGATOR WAS INSPECTED PRIOR TO USE AND NO DAMAGE OR ABNORMALITIES WERE IDENTIFIED AT THE TIME. THE SURGEON ELECTED TO CONVERT THE PROCEDURE TO OPEN SURGERY FOR AN UNSPECIFIED REASON.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 24234850 ↗
• MalfunctionJan 27, 2026

  THE SUCTION IRRIGATOR MALFUNCTIONED DURING SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24188327 ↗
• MalfunctionJan 16, 2026Suction Problem

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE SUCTION FUNCTION OF THE SUCTION IRRIGATOR KEPT GOING CONTINUOUSLY EVEN WHEN THE SURGEON TOOK THE FOOT OFF THE PEDAL. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24091030 ↗
• MalfunctionJan 15, 2026Suction Problem

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THERE WAS A COMPLETE LOSS OF INTRA-ABDOMINAL INSUFFLATION PRESSURE. IT WAS DISCOVERED THAT THE SUCTION IRRIGATOR SUCTION BUTTON WAS DEPRESSED IN THE FUNCTIONING POSITION, CAUSING CONSTANT SUCTION, AND COULD NOT BE UNDONE. 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 CUSTOMER REPORTED THAT THERE WAS NO INJURY TO THE PATIENT. THE ISSUE WAS RESOLVED BY REMOVING THE SUCTION IRRIGATOR, AND THE PROCEDURE WAS COMPLETED AS PLANNED WITHOUT THE NEED TO CONVERT TO OPEN SURGERY. THERE WERE NO FRAGMENTS AND THE PROCEDURE CONTINUED AS INTENDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24090410 ↗
• MalfunctionJan 5, 2026Break

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE 8MM SUCTION IRRIGATOR INSTRUMENT HAS A HOLE IN THE BLUE TUBE AT THE FRONT. THE PROCEDURE WAS CONTINUED AS PLANNED WITH NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23969221 ↗