EndoWrist;daVinci Si 420227Recalls & reported problems

Summary

The FDA's MAUDE database contains 27 adverse event reports that list this exact device (DI 00886874111673), received between Jun 15, 2017 and Oct 26, 2023 — classified as 3 injuries, 24 malfunctions.

The most frequently reported specific device problem is “Break” (11 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 27 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 26, 2023Thermal Decomposition of Device; Thermal Decomposition of Device

  REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18013022 ↗
• MalfunctionJun 5, 2023Unintended System Motion; Unintended System Motion

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED TOTAL BENIGN HYSTERECTOMY SURGICAL PROCEDURE, THE PK DISSECTING FORCEPS INSTRUMENT WAS NOT WORKING CORRECTLY AS IT STARTED FUNCTIONING OPPOSITE OF WHAT THE SURGEON WANTED. IT WAS INDICATED THAT THE SURGEON WOULD COMMAND THE INSTRUMENT TO MOVE TO THE RIGHT AND IT WOULD MOVE TO THE LEFT AND THE SAME REVERSAL WOULD OCCUR IN THE UP AND DOWN DIRECTIONS AS WELL. THE PROCEDURE WAS COMPLETED WITH A BACK-UP PK DISSECTING FORCEPS INSTRUMENT WITH NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17067310 ↗
• MalfunctionMay 28, 2023Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED PROCEDURE, THE PK DISSECTING FORCEPS INSTRUMENT HAD A BROKEN CABLE. THE PROCEDURE WAS COMPLETED AND THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17015872 ↗
• MalfunctionMay 27, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT PRIOR TO STARTING A DA VINCI-ASSISTED SURGICAL PROCEDURE, AN OR STAFF MEMBER NOTICED THE PK DISSECTING FORCEPS HAS WIRES EXPOSED. THE OPERATION ROOM STAFF COMPLETED CASE SET-UP AND A SIMILAR BACKUP DA VINCI INSTRUMENT WAS USED TO PROCEED WITH THE CASE. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17015748 ↗
• MalfunctionMay 27, 2023Break; Detachment of Device or Device Component; Material Split, Cut or Torn; Break; Detachment of Device or Device Component; Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING CENTRAL PROCESSING, THE PK DISSECTING FORCEPS WAS OBSERVED TO HAVING AN EXPOSED WIRE. THERE WAS NO REPORT OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17015557 ↗
• MalfunctionMay 21, 2023Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT DURING CENTRAL PROCESSING, THE PK DISSECTING FORCEPS HAD AN EXPOSED WIRE AT THE DISTAL END. THERE WAS NO REPORT OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16971143 ↗
• MalfunctionMay 21, 2023Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE CABLE ON THE INSTRUMENT BROKE. A SIMILAR BACKUP DA VINCI INSTRUMENT WAS USED TO CONTINUE WITH THE CASE. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16971140 ↗
• MalfunctionMay 21, 2023Crack; Crack

  IT WAS REPORTED THAT THERE WAS A CRACK IDENTIFIED IN THE INSTRUMENT AFTER OPENING THE BOX. THERE WAS NO PATIENT INVOLVED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16971138 ↗
• MalfunctionMay 21, 2023Thermal Decomposition of Device; Material Discolored; Thermal Decomposition of Device; Material Discolored

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE PK DISSECTING FORCEPS INSTRUMENT WAS NOT WORKING PROPERLY. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: NO FRAGMENTS FELL INTO A PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16971136 ↗
• MalfunctionMay 21, 2023Thermal Decomposition of Device; Thermal Decomposition of Device

  IT WAS REPORTED THAT DURING CENTRAL PROCESSING, THE TIP OF THE PK DISSECTING FORCEPS INSTRUMENTOUT WAS OUT OF ALIGNMENT. THERE WAS NO REPORT OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16971133 ↗
• MalfunctionMay 21, 2023Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING A DA VINCI ASSISTED TOTAL BENIGN HYSTERECTOMY PROCEDURE, THE JAWS OF THE PK DISSECTING FORCEPS INSTRUMENT JAWS REMAINED OPEN WHEN TRYING TO USE, AND THEY WOULD NOT GRASP TISSUE. THE INSTRUMENT APPEARED TO HAVE A CABLE LOOSE, WHEN CHECKED. THE PROCEDURE WAS COMPLETED AND THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16971132 ↗
• MalfunctionMay 21, 2023Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT DURING CENTRAL PROCESSING, THE TIPS OF THE DISSECTING FORCEPS INSTRUMENT WERE NOT ALIGNED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16971131 ↗
• InjuryMay 13, 2023Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED TOTAL BENIGN HYSTERECTOMY SURGICAL PROCEDURE, WHILE OPENING THE PK DISSECTING FORCEPS INSTRUMENT'S JAWS TO CUT TISSUE, A PLASTIC PIECE FROM THE PK DISSECTING FORCEPS INSTRUMENT BROKE OFF AND FELL INSIDE THE PATIENT. THE BROKEN PIECE WAS IMMEDIATELY RETRIEVED AND THE PK DISSECTING FORCEPS INSTRUMENT WAS REMOVED FROM THE FIELD. THE PROCEDURE WAS COMPLETED. INTUITIVE SURGICAL, INC. (ISI) OBTAINED THE FOLLOWING ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT: THE INSTRUMENT WAS INSPECTED PRIOR TO USE, AND NO DAMAGE WAS OBSERVED. PRIOR TO THE BREAKAGE, THE SURGEON DID NOT NOTICE ANY ISSUES WITH THE FUNCTIONALITY OF THE INSTRUMENT. THE INSTRUMENT DID NOT COLLIDE WITH ANY OTHER INSTRUMENTS OR HARD MATERIAL DURING THE SURGICAL PROCEDURE. THE FRAGMENT FELL INSIDE THE PATIENT WHEN THE SURGEON WAS GRASPING THE TISSUE. THE FRAGMENT WAS RETRIEVED WITH A LAPAROSCOPIC GRASPER INSTRUMENT. TO ENSURE ALL FRAGMENTS WERE RETRIEVED AND THERE WERE NO MISSING PIECES, THE CUSTOMER EXAMINED THE RETRIEVED FRAGMENT ON THE TABLE. THERE WERE NO POST-OPERATIVE TESTS PERFORMED TO CHECK FOR REMAINING FRAGMENTS. THERE WAS NO SURGICAL PROCEDURE REQUIRED TO REMOVE

  Patient problems: Foreign Body In Patient

  MAUDE report 16927437 ↗
• MalfunctionMay 13, 2023Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED UROLOGY SURGICAL PROCEDURE, A MEMBER OF THE OPERATING ROOM (OR) STAFF NOTICED A BROKEN/LOOSE DISSECTING FORCEPS INSTRUMENT CABLE. A SIMILAR BACK-UP DA VINCI INSTRUMENT WAS USED TO CONTINUE WITH THE CASE. PER THE REPORTER, NO FRAGMENTS FELL INTO THE PATIENT. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16925323 ↗
• MalfunctionMay 13, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT AFTER A DA VINCI-ASSISTED RADICAL PROSTATECTOMY WITH LYMPHADENECTOMY SURGICAL PROCEDURE, THE CUSTOMER OBSERVED THAT THE JAWS OF THE PK DISSECTING FORCEPS INSTRUMENT WERE MISALIGNED. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16925269 ↗
• MalfunctionMay 13, 2023Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED PROSTATECTOMY SURGICAL PROCEDURE, THE PK DISSECTING FORCEPS WAS FOUND TO HAVE A LOOSE CABLE. A BACKUP INSTRUMENT OF THE 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 16925268 ↗
• MalfunctionMay 13, 2023Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED RADICAL CYSTECTOMY SURGICAL PROCEDURE, THE INSTRUMENT WAS UNABLE TO BE CONTROLLED AND THE CABLE WAS FOUND TO BE BROKEN. A BACKUP INSTRUMENT WAS USED AND THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16925259 ↗
• MalfunctionMay 13, 2023Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  DURING A DA VINCI ASSISTED PROSTATECTOMY PROCEDURE, IT WAS REPORTED THAT THE PRONGS OF THE PK DISSECTING FORCEPS INSTRUMENT WERE BENT. THE PROCEDURE WAS COMPLETED AND THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16925257 ↗
• MalfunctionMay 13, 2023Break; Break

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE CUSTOMER INDICATED THAT THE PK DISSECTING FORCEPS WAS NO LONGER ARTICULATING. UPON CLOSER INSPECTION, THE INSTRUMENT WAS FOUND TO HAVE A BROKEN WIRE. A BACKUP INSTRUMENT WAS USED TO CONTINUE WITH THE CASE. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16925255 ↗
• InjuryMay 13, 2023Break; Break

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED MYOMECTOMY SURGICAL PROCEDURE, THE INSTRUMENT CABLE BROKE DURING THE PROCEDURE. A SMALL PIECE DETACHED AND FELL INSIDE THE PATIENT'S ANATOMY. THE FRAGMENT WAS RETRIEVED BY THE SURGEON. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. IT WAS REPORTED THAT THE BROKEN PIECE WOULD NOT BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16925233 ↗
• InjuryJun 30, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED TOTAL BENIGN HYSTERECTOMY PROCEDURE, BIPOLAR ENERGY STOPPED WORKING AND THE PATIENT EXPERIENCED A SMALL AMOUNT OF BLEEDING. THE ISSUE OCCURRED WHEN THE CUSTOMER ¿CHANGED BETWEEN THE FT10 BIPOLAR AND THE GYRUS PK BIPOLAR¿ INSTRUMENTS. THE PK INSTRUMENT HAD BEEN IN USE AND WORKED FINE THE ENTIRE PROCEDURE UP TO THE POINT OF THE SWAPPING INSTRUMENT ISSUE. THE SURGEON WAS WORKING WITH THE CERVIX WALL TO CUT AROUND AND DETACH THE CERVIX FROM VAGINAL WALL TO REMOVE THE UTERUS. THE SURGEON HAD CAUTERIZED WITH AN UNSPECIFIED INSTRUMENT AND WENT TO CONTINUE CAUTERY WITH THE PK DISSECTING FORCEPS (PK) INSTRUMENT BUT CAUTERY IN ¿THE PK DIDN¿T WORK¿ AND A SMALL AMOUNT OF BLEEDING FROM AN UNSPECIFIED SMALL VESSEL WAS OBSERVED. THE SURGEON QUICKLY CLAMPED THE VESSEL TO CONTROL THE SMALL AMOUNT OF ADDITIONAL BLEEDING THAT WAS DESCRIBED AS ¿LITTLE TO NO BLEEDING¿, ¿NOT ENOUGH TO EVEN MEASURE OR ESTIMATE¿ AND NO BLOOD TRANSFUSION WAS REQUIRED. THE PROCEDURE WAS COMPLETED WITH USE OF A BACKUP PK INSTRUMENT WITH CAUTERY FUNCTIONALITY AND WITH EXTERNAL FOOT PEDALS. THERE WAS NO PATIENT HARM OR INJURY. THE PATIENT IS DOING FINE AND THERE HAVE BEEN NO REPO

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 14867880 ↗
• MalfunctionFeb 26, 2022Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT PRIOR TO STARTING A DA VINCI-ASSISTED RADICAL PROSTATECTOMY WITH LYMPHADENECTOMY SURGICAL PROCEDURE, THE POWER CABLE OF THE PK DISSECTING FORCEPS INSTRUMENT WAS TORN. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) MADE MULTIPLE FOLLOW UP ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION, HOWEVER, NO FURTHER DETAILS HAVE BEEN RECEIVED AS OF DATE OF THIS REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13614959 ↗
• MalfunctionJul 30, 2021Material Split, Cut or Torn; Material Split, Cut or Torn

  REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12251896 ↗
• MalfunctionAug 28, 2020Break; Break

  IT WAS REPORTED THAT DURING CENTRAL PROCESSING, THE PK DISSECTING FORCEPS INSTRUMENT WAS FOUND TO HAVE A BROKEN CABLE. THERE WAS NO REPORT OF PATIENT INVOLVEMENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10469035 ↗
• MalfunctionMay 21, 2020Break; Break

  IT WAS REPORTED THAT PRIOR TO THE START OF A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE 8MM PK DISSECTING FORCEPS INSTRUMENT WAS FOUND TO HAVE AN EXPOSED WIRE. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10077865 ↗