EndoWrist;daVinci Si 420049Recalls & reported problems

Summary

The FDA's MAUDE database contains 40 adverse event reports that list this exact device (DI 00886874111338), received between Jan 30, 2017 and Mar 16, 2026 — classified as 6 injuries, 34 malfunctions.

The most frequently reported specific device problem is “Break” (18 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 40 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 16, 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 24612459 ↗
• MalfunctionJan 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: Insufficient Information

  MAUDE report 24228438 ↗
• MalfunctionJan 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 24228390 ↗
• MalfunctionSep 9, 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 23010923 ↗
• MalfunctionSep 5, 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 22984676 ↗
• MalfunctionJun 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 22145657 ↗
• MalfunctionMar 10, 2025Break; Break

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED MEDIASTINAL MASS RESECTION SURGICAL PROCEDURE, THE CADIERE FORCEPS HAD A BROKEN TIP. THE INSTRUMENT STILL HAD A LIFE. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. NO FRAGMENT FELL INTO THE PATIENT. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE SITE AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE INCIDENT OCCURRED DURING SURGERY, BUT NO FRAGMENTS OF THE MATERIAL WERE LOST AND NO HARM WAS DONE TO THE PATIENT. THERE HAVE BEEN NO REPORTS OF FRAGMENTS FALLING FROM THE DEVICE DURING USE. NO ACTION WAS TAKEN AS NO FRAGMENTS FELL DURING USE. THE SURGERY WAS COMPLETED SUCCESSFULLY AND THERE WERE NO COMPLICATIONS IN THE POST-OPERATIVE PERIOD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21567688 ↗
• MalfunctionFeb 7, 2025Material Fragmentation; Material Fragmentation

  REFER TO H11 FOR FOLLOW-UP INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21330327 ↗
• MalfunctionOct 3, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED BILIODIGESTIVE BYPASS SURGICAL PROCEDURE, THE PULLEY CABLES ON THE CADIERE FORCEPS WERE EXPOSED AND BROKEN. THE SURGEON HAD USED THE CADIERE FORCEPS AS A SEPARATOR WITH NO ISSUE IN THE LAST FIVE HOURS PRIOR TO THE INSTRUMENT BREAKAGE. THE SURGEON WAS NOT GRABBING ANYTHING WITHIN THE JAWS WHEN THE INCIDENT OCCURRED. THE CUSTOMER THEN STRAIGHTENED, OPENED, AND REMOVED THE INSTRUMENT. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. INTUITIVE SURGICAL INC. (ISI) FOLLOWED UP WITH THE CUSTOMER TO CONFIRM THAT THE CADIERE FORCEPS WAS INSPECTED PRIOR TO USE. THE CADIERE FORCEPS DID NOT COLLIDE WITH ANY OTHER INSTRUMENTS. NO FRAGMENTS FELL INSIDE THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17865014 ↗
• MalfunctionJun 15, 2023Unintended System Motion; No Apparent Adverse Event; Unintended System Motion; No Apparent Adverse Event

  REFER TO H10/H11 FOR FOLLOW-UP INFORMATION. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE CADIERE FORCEPS INSTRUMENT DID NOT MOVE BY ITSELF, ONLY THE SURGEON COULD NO LONGER MOVE IT IN A CERTAIN POSITION DUE TO THE FAILURE, IT REMAINED STATIONARY WITHOUT GENERATING ANY RISK TO THE PATIENT. THE ISSUE OCCURRED WITH THE SURGEON¿S HEAD INSIDE THE SURGEON CONSOLE¿S HIGH RESOLUTION STEREO VIEWER WHILE THE SURGEON WAS ATTEMPTING TO MANIPULATE INSTRUMENTS FROM THE SURGEON CONSOLE. THE INSTRUMENT REMAINED STATIC. INSTRUMENT MOVEMENT SCALED APPROPRIATELY, MOVED IN THE INTENDED DIRECTION, WITH APPROPRIATE TIMING. THERE WAS NO SHAKINESS/FRICTION OBSERVED. THE CUSTOMER WAS UNABLE TO TELL IF THERE WAS INSTRUMENT OR ARM INTERFERENCE. THERE WERE NO COLLISIONS. THE ISSUE WAS PERSISTENT. THE SURGEON WAS ATTEMPTING TO TAKE USUAL MOVEMENTS WITH THE INSTRUMENT. THE INSTRUMENT WAS REPLACED TO RESOLVE THE ISSUE. THE SAFETY WRENCH WAS USED TO REMOVE THE DEFECTIVE INSTRUMENT. THERE WAS NO INJURY TO THE PATIENT. THE INSTRUMENT WAS INSPECTED PRIOR TO USE AND NOTHING OUT OF THE ORDINARY WAS NOTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17136539 ↗
• MalfunctionMay 21, 2023Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT DURING CENTRAL PROCESSING, THE CADIERE FORCEPS HAD A GRASPER PADDLE WHICH BROKE OFF DURING THE FIRST STERILIZATION. THERE WAS NO REPORT OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16971248 ↗
• MalfunctionMay 21, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED LOBECTOMY SURGICAL PROCEDURE, THE CADIERE FORCEPS INSTRUMENT TIP AND THE INSERT WERE MISALIGNED AND IT WAS NOT POSSIBLE TO TAKE THE INSTRUMENT OUT FROM THE CANNULA. THE INSTRUMENT WAS RETRIEVED FROM THE PATIENT ALONG WITH THE CANULA AND THE ARM. THEN THE ONLY WAY TO TAKE OUT THE INSTRUMENT FROM THE CANULA WAS CUTTING THE DISTAL END OF THE INSTRUMENT. THIS WAS DONE AWAY FROM THE PATIENT. A 3RD PARTY INSTRUMENT WAS USED AND THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. THE CUSTOMER PROVIDED A PHOTOGRAPH SHOWING THE INSTRUMENT TIP DISLODGED FROM THE INSTRUMENT TUBE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16971188 ↗
• InjuryMay 13, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED CHOLECYSTECTOMY SURGICAL PROCEDURE, THE CUSTOMER NOTED THE CADIERE FORCEPS INSTRUMENT JAW BROKE OFF WHEN HITTING ANOTHER INSTRUMENT AND FELL INTO THE PATIENT. THE SURGEON REMOVED THE FRAGMENT FROM THE PATIENT. IT WAS NOTED THAT THE FRAGMENT WAS RETRIEVED USING A BACKUP INSTRUMENT. THE INTUITIVE REPRESENTATIVE MADE SURE THE FRAGMENT REMOVED MATCHED UP TO THE INSTRUMENT TO CONFIRM NOTHING WAS LEFT BEHIND. THE INSTRUMENT WRIST WAS STRAIGHTENED UPON REMOVAL. THE FRAGMENT WAS AVAILABLE FOR RETURN. NO VIDEO/IMAGE WAS AVAILABLE FOR REVIEW. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE CLINICAL TERRITORY ASSOCIATE (CTA) WHO CREATED THIS COMPLAINT AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE CTA INFORMED THE CADIERE FORCEPS INSTRUMENT WAS IN USE FOR ABOUT IN ON HOUR PRIOR TO THE REPORTED FRAGMENT FALLING INTO THE PATIENT. IT WAS NOTED THE INSTRUMENT WAS INSPECTED PRIOR TO USE WITH NO DAMAGE OBSERVED. THE CTA INFORMED THE CADIERE FORCEPS INSTRUMENT WAS REMOVED AT LEAST ONCE PRIOR TO THE FRAGMENT FALLING. WHEN THE REPORTED FRAGMENT FELL INTO THE PATIENT, THE CTA INFORMED THE CA

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16928186 ↗
• MalfunctionMay 6, 2023Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED ENUCLEATION OF ESOPHAGEAL LEIOMYOMA SURGICAL PROCEDURE, THE CADIERE FORCEPS INSTRUMENT WAS FOUND TO HAVE PHYSICAL DAMAGE. BACKUP INSTRUMENT OF SAME KIND WAS USED TO COMPLETE THE PROCEDURE. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16883588 ↗
• MalfunctionOct 13, 2022Unintended System Motion; Unintended System Motion

  REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15601883 ↗
• MalfunctionOct 1, 2022Unintended System Motion; Unintended System Motion

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE CADIERE FORCEPS INSTRUMENT MALFUNCTIONED. 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 CADIERE FORCEPS INSTRUMENT WAS REPORTEDLY MOVING NON-INTUITIVELY DURING THE PROCEDURE. THE INSTRUMENT WAS INSPECTED PRIOR TO USE WITH NO DAMAGE. THERE WAS NO PATIENT INJURY. THE PROCEDURE WAS COMPLETED ROBOTICALLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15526103 ↗
• MalfunctionSep 7, 2022Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED PULMONARY LOBECTOMY SURGICAL PROCEDURE, A STEEL CABLE CONTROLLING THE CADIERE FORCEPS INSTRUMENT BROKE. A BACKUP INSTRUMENT OF THE SAME TYPE WAS USED AND THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND PATIENT DEMOGRAPHIC INFORMATION WAS REQUESTED, BUT NOT PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15375435 ↗
• MalfunctionAug 14, 2022Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED PULMONARY LOBECTOMY PROCEDURE, THE CADIERE FORCEPS INSTRUMENT'S CABLE BROKE. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. THE CADIERE FORCEPS IS A MULTIPLE-USE ENDOSCOPIC INSTRUMENT 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. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER FOR ADDITIONAL INFORMATION; HOWEVER, NO RESPONSE HAS BEEN RECEIVED AT THE TIME OF THIS REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15222719 ↗
• InjuryNov 24, 2021Material Frayed; Material Frayed

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED PULMONARY SEGMENTECTOMY PROCEDURE OF THE LEFT UPPER LUNG, FRAYING OF A WIRE ON A CADIERE FORCEPS INSTRUMENT WAS IDENTIFIED AFTER ARTERIOVENOUS TREATMENT. THE WIRE/CABLE DAMAGE WAS IDENTIFIED IN THE FINAL STAGE OF THE PROCEDURE. HOWEVER, IT IS UNCLEAR IF THE SURGEON CONTINUED TO USE THE INSTRUMENT AFTER THE INSTRUMENT DAMAGE WAS FOUND. DURING A LEAK TEST, LEAKS WERE CONFIRMED FROM THE LOWER LOBES INSTEAD OF THE UPPER LOBES. THE LEAK WAS FROM THE LOWER LOBE, WHICH THE SURGEON DID NOT SPECIFICALLY TOUCH ACCORDING TO THE INITIAL REPORTER. SINCE IT WAS ON THE INSERTION PATH OF THE CADIERE FORCEPS, IT WAS SPECULATED THAT THE FRAYED WIRE MAY HAVE DAMAGED THE LOWER LOBE AND CAUSED THE LEAK. THE SURGEON TRIED TO CLOSE THE LEAK; HOWEVER, THE SURGEON CONVERTED THE PROCEDURE TO VATS TO FIX THE LEAK DUE TO A LACK OF A CLEAR SURGICAL VIEW. AN UNSPECIFIED DOCTOR FROM THE SITE COMMENTED: THE LEAK WAS COMING FROM THE LOWER LOBE, WHICH HAD NOT BEEN SPECIFICALLY TOUCHED. THE AIR LEAK WAS NOTED TO BE COMING FROM A SMALL HOLE THAT WAS DISCOVERED IN THE LOWER LOBE WHICH WAS ALONG THE INSERTION PATH OF THE CADIERE FORCEPS INSTRUMENT. THE SURGEON SUSPECTED T

  Patient problems: Unspecified Tissue Injury

  MAUDE report 12872677 ↗
• InjuryAug 27, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12381060 ↗
• InjuryJul 20, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12200572 ↗
• InjuryMay 27, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS INITIALLY REPORTED THAT THE CADIERE FORCEPS INSTRUMENT WAS USED TO GUIDE AN ULTRASOUND PROBE DURING THE PROCEDURE, AND ONE OF THE INSTRUMENT TIPS BROKE OFF AND FELL INTO THE PATIENT. THE INSTRUMENT TIP WAS REPORTED TO HAVE BEEN RETAINED IN THE PATIENT. FOLLOW-UP: ON 05/07/2021, INTUITIVE SURGICAL INC. (ISI) CONTACTED THE CUSTOMER AND ADDITIONAL INFORMATION WAS OBTAINED ABOUT THE COMPLAINT: THE CADIERE FORCEPS INSTRUMENT BROKE WHEN IT WAS GRASPING AN ULTRASOUND PROBE TO ASSIST IN GUIDING IT TO OBTAIN A VIEW OF THE TUMOR. THE SURGEON SEARCHED FOR THE FRAGMENT IN THE BOWEL, BUT COULD NOT FIND IT. THE SURGEON SAID THAT RETAINING THIS FRAGMENT WAS EQUAL TO A PATIENT RETAINING A CLIP ON THEIR ARTERY AND THERE WAS NO HARM. AN X-RAY WAS PERFORMED AFTER THE PROCEDURE WAS COMPLETED DURING THE SAME DAY; THE FRAGMENT COULD NOT BE FOUND IN THE X-RAY. IT WAS UNKNOWN IF THE SURGEON HAD AN OPINION ON HOW THE INSTRUMENT BROKE OR FOR HOW LONG THE INSTRUMENT WAS IN USE FOR BEFORE IT BROKE. IT WAS REPORTED THERE WAS NO PATIENT INJURY DURING THIS PROCEDURE. IT WAS REPORTED THAT THE PATIENT WAS DISCHARGED AND HAS NOT RETURNED TO THE HOSPITAL. THE PROCEDURE WAS A SMALL INTESTINE SEGMENTAL RESECTIO

  Patient problems: Foreign Body In Patient

  MAUDE report 11891918 ↗
• InjuryFeb 15, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11330712 ↗
• MalfunctionJan 30, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED PULMONARY LOBECTOMY SURGICAL PROCEDURE, THE CADIERE FORCEPS INSTRUMENT STOPPED RESPONDING TO COMMANDS. THE STEEL CABLES HAD BEEN CHECKED. A BACKUP INSTRUMENT OF THE SAME TYPE WAS USED AND THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11255620 ↗
• MalfunctionNov 18, 2020Break

  WE HAD AN INSTRUMENT BREAK WHILE INSIDE THE PATIENT DURING A DA VINCI HERNIA REPAIR WITH THE DOCTOR. IT WAS THE CADIERE FORCEPS AND THEY JUST QUIT FUNCTIONING BUT THEY WERE INSIDE THE PATIENT WHEN THAT HAPPENED. NOTE: FORCEP CHECKED AFTER REMOVAL AND IT WAS NOTED TO HAVE ZERO (0) LIVES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10860009 ↗