EndoWrist 470401Recalls & reported problems

Summary

The FDA's MAUDE database contains 132 adverse event reports that list this exact device (DI 00886874112670), received between Oct 22, 2021 and Aug 11, 2026 — classified as 22 injuries, 110 malfunctions.

The most frequently reported specific device problem is “Material Split, Cut or Torn” (42 reports).

2 FDA recall records name this device's identifier, 2 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 18, 2026.

Recalls naming this device

1. Dec 19, 2024Class IIOpen, Classified

   Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.

   Z-0870-2025 · Root cause: Process change control · Recall details · FDA record ↗

2. Jul 1, 2022Class IIOpen, Classified

   Due to the potential for unexpected motion caused by the partial disengagement of the instrument from the system.

   Z-1460-2022 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 132 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 11, 2026Detachment of Device or Device Component

  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 50216272 ↗
• InjuryAug 6, 2026Unintended Movement; Failure to Eject

  It was reported that during a da Vinci-assisted pulmonary lobectomy surgical procedure, the Small Clip Horizon Applier instrument experienced unintended motion, resulting in additional bleeding. It was noted that the cables or "spring" had snapped/broken and the instrument jerked to the left. While the surgeon was attempting to apply a clip to a small bronchial bleeder at a lymph node site, the Clip Applier instrument reportedly rotated 90 degrees rather than deploy the clip as intended. The surgeon indicted the deployment was supposed to be straightforward and non-obstructed. The unintended instrument motion resulted in tissue trauma, which led to additional bleeding. Hemostasis was controlled with direct pressure, application of Surgicel, and then additional pressure. Reported blood loss was less than 5mL. The surgeon then switched to using the Vessel Sealer instrument. The patient has been discharged and has not had any post-operative complications.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 50164319 ↗
• 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 25307975 ↗
• MalfunctionApr 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: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25009305 ↗
• InjuryApr 21, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE CLIPS FROM A HORIZON SMALL CLIP APPLIER INSTRUMENT WOULD LOOSEN AND FALL OFF WHEN GRIPPED. THE INSTRUMENT'S JAWS/GRIPS WERE NOT DAMAGED. THE INSTRUMENT'S GRIPS WERE REPORTEDLY WEAK AND WOULD NOT HOLD THE CLIPS. THE CLIPS WERE RETRIEVED BY THE ASSISTANT NURSE WITH THE CAMERA. NO ADDITIONAL SURGICAL PROCEDURES, SUCH AS LAPAROSCOPY OR OPEN SURGERY, WERE NECESSARY FOR REMOVAL, AND NO POST-OPERATIVE IMAGING SUCH AS AN X-RAY OR ULTRASOUND WERE CONDUCTED TO CHECK FOR REMAINING FRAGMENTS. THE PROCEDURE WAS COMPLETING AS PLANNED WITH NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24942830 ↗
• 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 24836624 ↗
• MalfunctionMar 30, 2026No Apparent Adverse Event

  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: Insufficient Information

  MAUDE report 24722705 ↗
• MalfunctionMar 20, 2026Material Frayed

  IT WAS REPORTED THAT THERE WAS A FRAYED 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 24654589 ↗
• MalfunctionMar 19, 2026No Apparent Adverse Event

  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 24644253 ↗
• MalfunctionMar 19, 2026No Apparent Adverse Event

  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 24644229 ↗
• MalfunctionMar 19, 2026Material Frayed

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

  Patient problems: Insufficient Information

  MAUDE report 24644172 ↗
• MalfunctionMar 19, 2026Material Frayed

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

  Patient problems: Insufficient Information

  MAUDE report 24644100 ↗
• MalfunctionMar 19, 2026Unintended System Motion

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED PULMONARY SEGMENTECTOMY SURGICAL PROCEDURE, THE SMALL HORIZON CLIP APPLIER INSTRUMENT TURNED 90 DEGREES WHILE CLIPPING. THE PROCEDURE WAS COMPLETED AND NO KNOWN IMPACT OR PATIENT CONSEQUENCE WAS REPORTED. INTUITIVE SURGICAL, INC. (ISI) CONTACTED THE CUSTOMER AND OBTAINED THE FOLLOWING INFORMATION: THIS ISSUE OCCURRED WITH THE SURGEON¿S HEAD INSIDE THE SURGEON CONSOLE¿S HIGH RESOLUTION STEREO VIEWER AND WHILE THE SURGEON WAS ATTEMPTING TO MANIPULATE THE INSTRUMENT FROM THE SURGEON CONSOLE. THE INSTRUMENT WAS NOT STATIC, AND THE MOVEMENT OF THE INSTRUMENT SCALED APPROPRIATELY WITH THE SURGEONS. THE INSTRUMENT MOVED IN THE INTENDED DIRECTION AND THE TIMING OF THE INSTRUMENT HAD NO DELAY. NO SHAKINESS WAS OBSERVED AND THERE WAS NO INSTRUMENT-TO-INSTRUMENT OR SYSTEM ARM-TO-ARM INTERFERENCE. THERE WERE NO EXTERNAL COLLISIONS. THE ISSUE WAS PERSISTENT AND THE CUSTOMER USED A BACK-UP CLIP APPLIER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24640669 ↗
• MalfunctionMar 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: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24632133 ↗
• MalfunctionMar 6, 2026Material Split, Cut or Torn

  REFER TO H11 FOR FOLLOW-UP INFORMATION.

  Patient problems: Insufficient Information

  MAUDE report 24537607 ↗
• MalfunctionFeb 27, 2026Unintended System Motion

  REFER TO H11 FOR FOLLOW-UP INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24470255 ↗
• MalfunctionFeb 26, 2026Material Split, Cut or Torn

  REFER TO H11 FOR FOLLOW-UP INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24465325 ↗
• MalfunctionFeb 26, 2026Material Split, Cut or Torn

  REFER TO H11 FOR FOLLOW-UP INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24465309 ↗
• MalfunctionFeb 26, 2026Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED MULTI VESSEL SMALL THORACOTOMY SURGICAL PROCEDURE, THE HORIZON SMALL CLIP APPLIER INSTRUMENT CLIPPED THREE BRANCHES OF ARTERIES AND THEN THE CABLE BROKE. 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 INSTRUMENT DID NOT COLLIDE WITH ANY OTHER INSTRUMENT OR TOOL DURING THE PROCEDURE. THERE WERE NO ISSUES RELATED TO OPENING/CLOSING OF THE GRIPS. THERE WERE NO ISSUES RELATED TO LEFT/RIGHT (YAW) MOTION OF THE GRIPS. THERE WERE NO ISSUES RELATED TO UP/DOWN (PITCH) MOTION OF THE WRIST. THE ISSUE WAS RESOLVED WITH A BACKUP INSTRUMENT. THERE ARE NO PHOTOS AND/OR VIDEOS OF THIS EVENT AVAILABLE FOR ISI REVIEW. PATIENT DEMOGRAPHICS WERE REQUESTED BUT WERE UNABLE TO BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24463256 ↗
• MalfunctionFeb 26, 2026Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE HORIZON SMALL CLIP APPLIER HAD A SNAPPED WIRE. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24453728 ↗
• MalfunctionFeb 20, 2026Material Split, Cut or Torn

  REFER TO H11 FOR FOLLOW-UP INFORMATION.

  Patient problems: Insufficient Information

  MAUDE report 24407642 ↗
• MalfunctionFeb 19, 2026Break

  REFER TO H11 FOR FOLLOW-UP INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24395943 ↗
• MalfunctionFeb 19, 2026Material Frayed

  REFER TO H11 FOR FOLLOW-UP INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24395826 ↗
• MalfunctionFeb 9, 2026Break

  REFER TO H11 FOR FOLLOW-UP INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24299490 ↗
• MalfunctionFeb 5, 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 24265471 ↗