EndoWrist 470184Recalls & reported problems

Summary

The FDA's MAUDE database contains 708 adverse event reports that list this exact device (DI 00886874112328), received between Jun 29, 2017 and Sep 30, 2026 — classified as 56 injuries, 651 malfunctions.

The most frequently reported specific device problem is “Material Split, Cut or Torn” (240 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 708 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Energy Output Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50953179 ↗
• MalfunctionSep 29, 2026Thermal Decomposition of Device

  It was reported that during a da Vinci-assisted surgical procedure, noticeable abnormal smoke occurred following the release of energy from the tip of the Permanent Cautery Spatula. The procedure was completed with no reported injury.

  Patient problems: Insufficient Information

  MAUDE report 50939631 ↗
• MalfunctionSep 29, 2026Detachment of Device or Device Component

  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: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50928030 ↗
• MalfunctionSep 29, 2026Break

  It was reported that prior to the start of a da Vinci-assisted surgical procedure, the Permanent Cautery Spatula instrument articulation/joint was broken. The procedure was completed with no reported injury.Intuitive followed up and obtained additional information via customer checklist. Issue was broken part at the articulation and joint of the instrument. There were five lives left. Procedure was on (b)(6)2026. Procedure was a robotic treatment of endometriosis and lysis of adhesions. A backup instrument was used and no patient harm. Nothing fell in the patient.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50928008 ↗
• MalfunctionSep 28, 2026Material Split, Cut or Torn

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50926104 ↗
• MalfunctionSep 28, 2026Material Split, Cut or Torn

  Patient problems: Insufficient Information

  MAUDE report 50924665 ↗
• InjurySep 28, 2026Arcing

  It was reported that during a da Vinci-assisted uvulopalatopharyngoplasty procedure, the Permanent Cautery Spatula (PCS) instrument was in use when the patient sustained an injury to the right soft palate. The incident occurred while the surgeon was performing the tongue base resection. At that point, the PCS instrument tip was oriented upward toward the tongue base, while the ¿wrist¿ portion of the PCS instrument was positioned near the soft palate. It is suspected that the insulated black energy wire was exposed, resulting in unintended energy discharge to the soft palate tissue. Although the bleeding was minimal, it was attributable to this event. There was no significant blood loss; however, the tissue sustained a degree of thermal injury/burn. The affected tissue was sutured and Surgiseal was applied. The procedure was completed robotically, and no postoperative complications were reported. The surgeon expressed concern for potential long-term effects, including dysphagia and altered taste. The patient has been discharged and is being followed with weekly outpatient visits.An ERBE VIO dV generator was used during the procedure with settings of Monopolar Coag 2 and Bipolar Soft

  Patient problems: Burn(s); Hemorrhage/Blood Loss/Bleeding

  MAUDE report 50913513 ↗
• MalfunctionSep 24, 2026Material Split, Cut or Torn

  Patient problems: Insufficient Information

  MAUDE report 50891232 ↗
• OtherSep 23, 2026Arcing

  It was reported that during a da Vinci-assisted supraglottic laryngectomy, energy from the Permanent Cautery Spatula dispersed through the pulley cables, resulting in an injury to the interior of the patient's throat. The instrument had been inspected prior to use with no abnormalities observed. An arc was formed between one of the wires at the distal end of the instrument and the affected area of the throat at the time Monopolar Coag energy was activated. The tip of the Permanent Cautery Spatula did not come into contact with any other instrument or tool during the procedure. The procedure was completed with a 15-30-minute delay. The injury did not result in any complications, long-term sequelae, or the need for additional intervention, and the patient recovered well.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 50867261 ↗
• MalfunctionAug 13, 2026Detachment of Device or Device Component

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50242938 ↗
• MalfunctionAug 11, 2026Material Split, Cut or Torn

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50216296 ↗
• MalfunctionAug 10, 2026Break

  It was reported that during central processing, the Permanent Cautery Spatula instrument's insulated area near the tip was chipped. No known impact or patient consequence was reported.ISI followed up with the initial reporter and obtained the following additional information: There was a visible section missing at the insulated area. It wasn't used on a case as this was visually noticed beforehand. There was no arcing.

  Patient problems: Insufficient Information

  MAUDE report 50196616 ↗
• MalfunctionJun 1, 2026Thermal Decomposition of Device

  IT WAS REPORTED THAT THE PERMANENT CAUTERY SPATULA INSTRUMENT TIP WAS DAMAGED. THERE WAS NO REPORT OF PATIENT INVOLVEMENT OR PATIENT INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: NO REPORT OF MATERIAL BROKEN OFF OR DETACHED. THERE WAS THE LOCATION THAT LOOKED A SLIGHT CRACK OR SCRATCH ON THE TIP. THERE WERE NO NOTICEABLE DEFECTS WITH THE CABLE. NO PHOTOGRAPHIC IMAGES OF THE INSTRUMENT AVAILABLE FOR REVIEW.

  Patient problems: Insufficient Information

  MAUDE report 25352532 ↗
• MalfunctionMay 27, 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 25307378 ↗
• MalfunctionMay 26, 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 25291517 ↗
• MalfunctionMay 15, 2026Break

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE TIP OF A PERMANENT CAUTERY SPATULA INSTRUMENT HAS BEEN DAMAGED. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY.

  Patient problems: Insufficient Information

  MAUDE report 25179993 ↗
• InjuryMay 4, 2026Material Fragmentation

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED PULMONARY LOBECTOMY PROCEDURE, THE PERMANENT CAUTERY SPATULA (PCS) INSTRUMENT BROKE AT THE CHEST ENTRY SITE, RESULTING IN LOSS OF A PLASTIC COMPONENT. AN INITIAL INSPECTION OF THE INSTRUMENT WAS PERFORMED PRIOR TO USE, WHICH FOCUSED ABOVE ALL ON THE PRESENCE OF THE INTEGRITY OF THE METAL BLADE AND NO APPARENT ANOMALIES WERE IDENTIFIED. HOWEVER, WITH THE VIEW ON THE MONITOR (MAGNIFIED), A MISSING FRAGMENT AT THE BEGINNING OF THE PROCEDURE WAS OBSERVED. THE SURGEON WAS IMMEDIATELY NOTIFIED AND INSPECTED THE CHEST CAVITY AT THE END OF THE PROCEDURE. NO FRAGMENTS WERE FOUND. NO ADDITIONAL SURGICAL PROCEDURE REQUIRED FOR THE REMOVAL OF THE FRAGMENT. NO POST-OPERATIVE EXAMINATIONS, SUCH AS X-RAY OR ULTRASOUND WERE PERFORMED. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY.

  Patient problems: Foreign Body In Patient

  MAUDE report 25070872 ↗
• MalfunctionApr 30, 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: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25051176 ↗
• MalfunctionApr 17, 2026Material Split, Cut or Torn

  IT WAS REPORTED THAT AFTER A DA VINCI-ASSISTED RADICAL SURGICAL PROCEDURE, THE PERMANENT CAUTERY SPATULA INSTRUMENT WAS FOUND DEFECTIVE. THERE WAS NO REPORT OF PATIENT HARM DUE TO THIS EVENT. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION ON 13-APR-2026: SOME ARMS WERE MISSING FROM THE WHEELS THAT ATTACH TO THE MECHANISM CONNECTING TO THE ROBOT ARM. SOME ARMS HAD EXPOSED WIRING AND WERE NON-FUNCTIONAL. SOME ARMS HAD CABLING THAT HAD SNAPPED AT THE ELBOW OF THE DEVICE.

  Patient problems: Insufficient Information

  MAUDE report 24918179 ↗
• MalfunctionApr 17, 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: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24917318 ↗
• MalfunctionApr 15, 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 24890696 ↗
• MalfunctionApr 15, 2026Thermal Decomposition of Device

  REFER TO H11 FOR FOLLOW-UP INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24890058 ↗
• MalfunctionApr 13, 2026Material Split, Cut or Torn

  REFER TO H11 FOR FOLLOW-UP INFORMATION.

  Patient problems: Insufficient Information

  MAUDE report 24866632 ↗
• MalfunctionApr 11, 2026Material Split, Cut or Torn

  REFER TO H11 FOR FOLLOW-UP INFORMATION.

  Patient problems: Insufficient Information

  MAUDE report 24849364 ↗
• MalfunctionApr 9, 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: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24836846 ↗