EndoWrist 470246Recalls & reported problems

Summary

The FDA's MAUDE database contains 22 adverse event reports that list this exact device (DI 00886874112397), received between Apr 7, 2017 and May 6, 2026 — classified as 3 injuries, 19 malfunctions.

The most frequently reported specific device problem is “Material Split, Cut or Torn” (5 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. Dec 19, 2024Open, Classified

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

   Z-0862-2025 · Root cause: Process change control · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 22 most recent of 22 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 6, 2026Unintended Movement

  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 25090284 ↗
• MalfunctionApr 28, 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 25022521 ↗
• MalfunctionApr 8, 2026Material Twisted/Bent

  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 24822642 ↗
• MalfunctionMar 5, 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 24526222 ↗
• MalfunctionFeb 27, 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 24476549 ↗
• MalfunctionFeb 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: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24395615 ↗
• MalfunctionFeb 19, 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 24395595 ↗
• MalfunctionJan 8, 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 24014516 ↗
• MalfunctionDec 23, 2025Unintended System Motion; Unintended System Motion

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE ATRIAL RETRACTOR SHORT RIGHT MOVEMENT WAS NOT RIGHT. THE PROCEDURE WAS CONTINUED AS PLANNED WITH NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23881267 ↗
• MalfunctionSep 12, 2025No Device Output; No 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 23044138 ↗
• InjurySep 9, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED MITRAL VALVE REPAIR PROCEDURE, CABLE FIBERS WERE FOUND TO BE BROKEN IN THE SHORT RIGHT ATRIAL RETRACTOR INSTRUMENT. PER HOSPITAL POLICY, AN X-RAY WAS PERFORMED AT THE END OF THE CASE WHENEVER AN INSTRUMENT BREAKAGE IS SUSPECTED. THE DAMAGE TO THE INSTRUMENT WAS IDENTIFIED DURING ITS REMOVAL FROM THE ROBOTIC ARM AFTER THE SURGERY WAS COMPLETED. NO FRAGMENTS WERE DETECTED INSIDE THE PATIENT, AND NO ADDITIONAL SURGICAL INTERVENTION WAS NECESSARY TO RETRIEVE ANY DEBRIS. THE PROCEDURE WAS COMPLETED WITHOUT THE NEED FOR A BACKUP INSTRUMENT. THE PATIENT HAS NOT PRESENTED WITH ANY POST-OPERATIVE COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23005482 ↗
• MalfunctionJul 10, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  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 22474266 ↗
• MalfunctionMay 13, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  REFER TO H11 FOR FOLLOW-UP INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22014655 ↗
• InjurySep 4, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.

  Patient problems: Foreign Body In Patient

  MAUDE report 20139259 ↗
• MalfunctionMay 9, 2024Unintended System Motion; Unintended System Motion

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE ATRIAL RETRACTOR SHORT RIGHT (ARSR) MOVED IN AN UNEXPECTED DIRECTION. THE CUSTOMER USED A BACKUP INSTRUMENT TO CONTINUE WITH THE PROCEDURE. 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 ISSUE. THERE WAS NO FRAGMENT FALLING INSIDE THE PATIENT¿S ANATOMY. THE PROCEDURE WAS NOT DELAYED. THE PROCEDURE WAS COMPLETED ROBOTICALLY WITH THE SAME DA VINCI SYSTEM. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19282894 ↗
• MalfunctionApr 20, 2024Break; Break

  IT WAS REPORTED THAT AFTER A DA VINCI-ASSISTED MITRAL VALVE REPAIR SURGICAL PROCEDURE, THE ATRIAL RETRACTOR SHORT RIGHT INSTRUMENT WAS FOUND TO HAVE A BROKEN CABLE WHEN CHECKING WITH A MAGNIFYING GLASS AFTER PRELIMINARY CLEANING. THERE WERE NO DEVICE MALFUNCTIONS DURING THE PROCEDURE. THERE WAS NO REPORT OF FRAGMENT(S) FALLING INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITH A BACKUP INSTRUMENT OF SAME KIND. NO KNOWN IMPACT OR PATIENT CONSEQUENCE WAS REPORTED. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE SITE AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT: THE INSTRUMENT WAS INSPECTED PRIOR TO USE. NO DAMAGE OR ANYTHING OUT OF THE ORDINARY CONFIRMED. THE INSTRUMENT DID NOT COLLIDE WITH ANY OTHER INSTRUMENT OR TOOL DURING PROCEDURE. THE CUSTOMER FOUND THE BROKEN CABLE AFTER THE PROCEDURE. NO ISSUES RELATED TO OPENING/CLOSING OF THE GRIPS, LEFT/RIGHT (YAW) MOTION OF THE GRIPS, UP/DOWN (PITCH) MOTION OF THE WRIST. NO CABLES VISIBLY PROTRUDING FROM THE DISTAL END OF THE INSTRUMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19149784 ↗
• MalfunctionMar 28, 2024Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT DURING CENTRAL PROCESSING THE ATRIAL RETRACTOR INSTRUMENT HAD A BROKEN CABLE. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18995409 ↗
• MalfunctionNov 1, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE ATRIAL RETRACTOR SHORT RIGHT INSTRUMENT DID NOT WORK. THE PROCEDURE WAS COMPLETED AS PLANNED WITH NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18052241 ↗
• MalfunctionSep 17, 2023Detachment of Device or Device Component; Difficult to Open or Close; Detachment of Device or Device Component; Difficult to Open or Close

  IT WAS REPORTED THAT DURING A DA VINCI ASSISTED MITRAL VALVE REPAIR SURGICAL PROCEDURE, THE ATRIAL RETRACTOR SHORT RIGHT INSTRUMENT WOULD NOT OPEN. A BACKUP INSTRUMENT WAS USED TO COMPLETE THE PROCEDURE WITH NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17762238 ↗
• MalfunctionJun 24, 2023Material Fragmentation; No Apparent Adverse Event; Material Fragmentation; No Apparent Adverse Event

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED MITRAL VALVE REPAIR SURGICAL PROCEDURE, THE ATRIAL RETRACTOR SHORT RIGHT (ARSR) INSTRUMENT COULD NOT BE OPENED AND CLOSED DUE TO A BROKEN SILVER CABLE. THE CUSTOMER USED A NEW ARSR INSTRUMENT TO CONTINUE WITH THE SURGERY. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. ISI FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THERE WAS NO REPORT OF A FRAGMENT FALLING INTO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17196060 ↗
• MalfunctionJul 7, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED DURING A DA VINCI-ASSISTED MITRAL VALVE REPAIR SURGICAL PROCEDURE, THE SHORT RIGHT ATRIAL RETRACTOR INSTRUMENT HAD A BROKEN CABLE. THE PROCEDURE WAS COMPLETED AS PLANNED WITH NO REPORT OF PATIENT HARM, ADVERSE OUTCOME OR INJURY. INTUITIVE SURGICAL, INC. (ISI) OBTAINED THE FOLLOWING INFORMATION FROM THE INITIAL REPORTER ABOUT THE COMPLAINT: THE INSTRUMENT WAS INSPECTED PRIOR TO LAST USE AND NO ISSUES WERE IDENTIFIED. IT IS UNKNOWN IF THERE WERE ANY INSTRUMENT COLLISIONS AT THE TIME OF USE. IT IS UNKNOWN IF THE PATIENT RETURNED DUE TO ANY POST-OPERATIVE COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14950859 ↗
• InjuryApr 7, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS INITIALLY REPORTED THAT DURING A DA VINCI-ASSISTED MITRAL VALVE REPAIR PROCEDURE, THE 8 MM ATRIAL RETRACTOR SHORT RIGHT INSTRUMENT ALLEGEDLY MAY HAVE CAUSED A TEAR IN THE ATRIUM. ON 03/20/2017, INTUITIVE SURGICAL, INC. (ISI) CONTACTED THE ISI CLINICAL SALES REPRESENTATIVE (CSR) AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE CSR REPORTED THAT HE WAS PRESENT DURING THE SURGICAL PROCEDURE. HE STATED THAT WHEN THE SURGEON WAS MANIPULATING THE 8 MM ATRIAL RETRACTOR SHORT RIGHT INSTRUMENT, THE SURGEON NOTICED A TEAR IN THE ATRIUM. THE TEAR WAS DESCRIBED TO BE ABOUT 1.00-1.55 MM IN LENGTH. THE SURGEON STATED THAT THE TISSUE INTEGRITY WAS VERY POOR. THE SURGEON SUTURED THE TEAR WITH AN UNSPECIFIED INSTRUMENT AND CONTINUED WITH THE PROCEDURE. HOWEVER, IMMEDIATELY AFTER, THE SURGEON SAW EVIDENCE OF A SECOND TEAR. AT THAT POINT THE SURGEON ALLEGED THAT THE TEARS MAY HAVE BEEN RELATED TO THE USE OF THE 8 MM ATRIAL RETRACTOR SHORT RIGHT INSTRUMENT, AND NOT THE INTEGRITY OF THE TISSUE. THE SURGEON SUTURED THE SECOND TEAR WITH AN UNSPECIFIED INSTRUMENT. HE THEN FLIPPED OR ROTATED THE INSTRUMENT TIPS AND CONTINUED WITH THE PROCEDURE. THE PLANNED SURGICAL PROCEDURE WAS COMPLETED WITH

  Patient problems: Injury; Visual Disturbances

  MAUDE report 6472998 ↗