EndoWrist;daVinci Si 420093Recalls & reported problems

Summary

The FDA's MAUDE database contains 63 adverse event reports that list this exact device (DI 00886874111345), received between Mar 24, 2017 and Mar 16, 2026 — classified as 6 injuries, 57 malfunctions.

The most frequently reported specific device problem is “Break” (15 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 63 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 16, 2026Material Split, Cut or Torn

  REFER TO H11 FOR FOLLOW-UP INFORMATION.

  Patient problems: Insufficient Information

  MAUDE report 24612452 ↗
• MalfunctionFeb 26, 2026Material Split, Cut or Torn

  IT WAS REPORTED THAT PRIOR TO THE START OF A DA VINCI-ASSISTED PROSTATECTOMY SURGICAL PROCEDURE, THE PROGRASP FORCEPS HAD BROKEN CABLES. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24452044 ↗
• MalfunctionFeb 24, 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 24438247 ↗
• MalfunctionOct 23, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  REFER TO H11 FOR FOLLOW-UP INFORMATION.

  Patient problems: Insufficient Information

  MAUDE report 23374495 ↗
• MalfunctionJun 18, 2025Material Split, Cut or Torn; Material 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 22287787 ↗
• MalfunctionMar 23, 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 21674305 ↗
• MalfunctionMar 20, 2025Break; Break

  REFER TO H11 FOR FOLLOW-UP INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21658250 ↗
• MalfunctionMar 13, 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 21600084 ↗
• MalfunctionMar 13, 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 21600080 ↗
• MalfunctionMar 4, 2025Material Split, Cut or Torn; Material 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 21512074 ↗
• MalfunctionFeb 25, 2025Material Frayed; Material 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 21459205 ↗
• MalfunctionJun 6, 2024Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED RADICAL CURE OF PROSTATE CANCER SURGICAL PROCEDURE, THE 8MM PROGRASP FORCEPS HAD THE JOINT DISCONNECTED FROM THE PLIERS. ISI FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE PROCEDURE NAME WAS RADICAL CURE OF PROSTATE CANCER. THE SURGEON'S NAME WAS (B)(6). THERE WERE NO FRAGMENTS THAT FELL IN THE PATIENT WHILE THE INSTRUMENT'S USE WITHIN THE PATIENT. THE INSTRUMENT WAS CHECKED BEFORE USE. NO ABNORMALITIES WERE FOUND.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19474147 ↗
• MalfunctionDec 1, 2023Difficult to Open or Close; Difficult to Open or Close

  REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18244176 ↗
• MalfunctionNov 3, 2023Unintended System Motion; Unintended System Motion

  REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18067706 ↗
• MalfunctionOct 26, 2023Unintended Movement; Unintended Movement

  REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.

  Patient problems: Insufficient Information

  MAUDE report 18013420 ↗
• InjuryAug 25, 2023Defective Component; Defective Component

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED PROSTATECTOMY PROCEDURE, ONE SIDE OF THE PROGRASP FORCEPS INSTRUMENT JAW WAS NOT MOVING SMOOTHLY. THE INSTRUMENT WAS REMOVED AND IT WAS OBSERVED THAT A WIRE HAD BECOME DISLODGED WITHIN AND ¿THE DISC¿ DID NOT WORK. IT WAS REPORTED THAT TISSUE WAS LODGED IN THE SMALL CREVICES OF THE INSTRUMENT. IMMEDIATELY AFTER REMOVING THE INSTRUMENT, MINOR TISSUE DAMAGE WAS IDENTIFIED WHEN THE SURGICAL STAFF CHECKED THE PATH OF REMOVAL OF THE PROGRASP FORCEPS INSTRUMENT FROM THE CANNULA TO THE TARGET TISSUE TO ENSURE THERE WERE NO ISSUES IN THE ABDOMINAL CAVITY. IT IS UNKNOWN AS TO WHAT TYPE OF MINOR TISSUE DAMAGE/INJURY WAS NOTED ON THE INSIDE OF THE PERITONEUM. THERE WAS NO BLEEDING OBSERVED AND NO FRAGMENTS FELL INSIDE THE PATIENT¿S BODY. WHEN CHECKING THE INSTRUMENT AFTER REMOVAL, THEY ¿RESTORED¿ THE WIRE AND THE PROGRASP FORCEPS STILL DID NOT MOVE. AFTER CONSULTING WITH THE GENERAL SURGERY COLORECTAL TEAM, THE MINOR TISSUE DAMAGE WAS REPAIRED WITH TWO STITCHES. THE PROCEDURE WAS COMPLETED ROBOTICALLY USING A BACK-UP PROGRASP FORCEPS INSTRUMENT. THE SURGEON DID NOT ADMINISTER ANY ADDITIONAL TREATMENT TO THE TISSUES. THE PATIENT DID NOT EXPERIENCE

  Patient problems: Unspecified Tissue Injury

  MAUDE report 17627871 ↗
• MalfunctionAug 12, 2023Unintended System Motion; Unintended System Motion

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE PROGRASP FORCEPS INSTRUMENT DID NOT MOVE THE WAY THE SURGEON WANTED IT. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) MADE MULTIPLE FOLLOW-UPS ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION. HOWEVER, NO FURTHER DETAILS HAVE BEEN RECEIVED AS OF THE DATE OF THIS REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17532045 ↗
• MalfunctionJul 26, 2023Unintended System Motion; Unintended System Motion

  REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17398848 ↗
• MalfunctionJun 5, 2023Visual Prompts will not Clear; Visual Prompts will not Clear

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED PARTIAL NEPHRECTOMY SURGICAL PROCEDURE, AFTER THE KIDNEY WAS UNCLAMPED AND THE BEGINNING OF THE RECONSTRUCTION WAS OCCURRING; REPEATED RECOVERABLE 48100 FAULTS OCCURRED. THE FAULT REMAINED EVEN AFTER TROUBLESHOOTING WITH DVSTAT AND REBOOTING THE SYSTEM AND COMPLETING A HARD CYCLE POWER. SINCE THE NEEDLE DRIVER INSTRUMENT WAS HOLDING A NEEDLE THE INSTRUMENT RELEASE KIT (IRK) WAS USED TO SAFELY REMOVE IT WHICH IS WHY THE INSTRUMENT IS BEING RETURNED. THE SURGEON MADE THE DECISION TO CONVERT THE PROCEDURE TO TRADITIONAL LAPAROSCOPIC TECHNIQUES WITH NO REPORTED INJURY. THE PROGRASP FORCEPS INSTRUMENTS ARE MULTIPLE-USE ENDOSCOPIC INSTRUMENTS WITH A GRASPING TIP TO BE USED IN CONJUNCTION WITH THE DA VINCI SYSTEM. THE INSTRUMENT IS DESIGNED TO GRAB, MANIPULATE, RETRACT, AND DISSECT TISSUE DURING A DA VINCI ASSISTED SURGICAL PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17067484 ↗
• MalfunctionJun 5, 2023Unintended System Motion; Unintended System Motion

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE PROGRASP FORCEPS INSTRUMENT MADE MOVEMENTS IN THE OPPOSITE DIRECTIONS FROM WHAT WAS INDICATED/INTENDED BY THE SURGEON. THE SITE RESTARTED THE SYSTEM AND REPOSITIONED THE SYSTEM ARM WITH NO CHANGE. THE SITE THEN REPLACED THE INSTRUMENT TO RESOLVE THE PROBLEM AND CONTINUE WITH THE PROCEDURE. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17067320 ↗
• MalfunctionJun 5, 2023Unintended System Motion; Unintended System Motion

  IT WAS REPORTED, THAT DURING A DA VINCI-ASSISTED RADICAL SALVAGE PROSTATECTOMY SURGICAL PROCEDURE. THE PROGRASP FORCEPS INSTRUMENT SHOWED AN INVERSION OF ROTATION, YAW AND TILT. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY USING A BACKUP PROGRASP FORCEPS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17067318 ↗
• MalfunctionJun 5, 2023Unintended System Motion; Difficult to Open or Close; Unintended System Motion; Difficult to Open or Close

  IT WAS REPORTED DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE INSTRUMENT JAWS COULD NOT BE OPENED OR CLOSED PROPERLY. THE SITE USED A BACK-UP INSTRUMENT TO CONTINUE THE PROCEDURE. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17067317 ↗
• MalfunctionJun 5, 2023Unintended System Motion; Unintended System Motion

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED PROSTATECTOMY SURGICAL PROCEDURE, THE INSTRUMENT WOULD MOVE IN THE OPPOSITE DIRECTIONS AS THAT OF THE MANIPULATORS. A BACKUP INSTRUMENT WAS USED. THE PROCEDURE WAS COMPLETED WITH A BACKUP INSTRUMENT AND THERE NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17067316 ↗
• MalfunctionJun 5, 2023Unintended System Motion; Unintended System Motion

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE JAW OF THE PROGRASP FORCEPS WAS NOT FULLY OPENED AND WAS NOT MOVING SMOOTHLY. THE CUSTOMER USED A BACKUP INSTRUMENT TO CONTINUE. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17067311 ↗
• MalfunctionMay 28, 2023Difficult to Open or Close; Difficult to Open or Close

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE INSTRUMENT WAS FOUND TO HAVE A RESTRICTED JOINT MOVEMENT. A BACKUP INSTRUMENT WAS USED. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17016017 ↗