EndoWrist;daVinci Si 420110Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00886874111352), received between Sep 29, 2019 and Oct 24, 2023 — classified as 1 injury, 10 malfunctions.

The most frequently reported specific device problem is “Break” (4 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 24, 2023Thermal Decomposition of Device; Thermal Decomposition of Device

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED RADICAL PROSTATECTOMY WITHOUT LYMPHADENECTOMY SURGICAL PROCEDURE, THE PRECISE BIPOLAR FORCEPS (PBF) INSTRUMENT HAD A POOR RECOGNITION ISSUE. THE INSTRUMENT WAS CLEANSED, AND STERILE ADAPTER WAS REATTACHED, BUT THE ISSUE WAS NOT RESOLVED. THE PROCEDURE WAS COMPLETING AS PLANNED 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 THE DATE OF THIS REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17997226 ↗
• MalfunctionMay 27, 2023Break; Detachment of Device or Device Component; Difficult to Open or Close; Break; Detachment of Device or Device Component; Difficult to Open or Close

  IT WAS REPORTED DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THERE WAS DAMAGE TO THE INSULATOR AT THE FRONT OF THE INSTRUMENT HOUSING OF THE PRECISE BIPOLAR FORCEP. THE SITE REPLACED THE INSTRUMENT TO RESOLVE THE ISSUE. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17015534 ↗
• MalfunctionMay 21, 2023Thermal Decomposition of Device; Thermal Decomposition of Device

  IT WAS REPORTED THAT DURING CENTRAL PROCESSING, THE PLASTIC PROTECTION OF THE CABLE WAS NOT IN THE JAWS OF THE DAMAGED CLAMP. THERE WAS NO REPORT OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16971137 ↗
• MalfunctionMay 13, 2023Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT PRIOR TO STARTING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE INSPECTION OF THE PRECISE BIPOLAR FORCEPS INSTRUMENT IDENTIFIED PHYSICAL DAMAGE ON THE CONDUCTOR WIRE INSULATION. PLANNED USE OF THE INSTRUMENT WAS DISCONTINUED. FOLLOWING THIS, THE USER CONTINUED THE PLANNED PROCEDURE WITH NO FURTHER ISSUE REPORTED. NO FRAGMENT FELL INTO THE PATIENT'S ANATOMY. THERE WAS NO KNOWN IMPACT OR PATIENT CONSEQUENCE WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16925272 ↗
• MalfunctionMay 13, 2023Break; Break

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED PROSTATECTOMY SURGICAL PROCEDURE, THE RUBBER PIECE ON THE PRECISE BIPOLAR FORCEPS WAS 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 16925270 ↗
• MalfunctionMay 13, 2023Difficult to Open or Close; Difficult to Open or Close

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE PRECISE BIPOLAR FORCEPS INSTRUMENT JAWS WOULD NOT OPEN. 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 JAWS OF THE PRECISE BIPOLAR FORCEPS INSTRUMENT WOULD NOT OPEN. THE ISSUE WAS IDENTIFIED DURING SURGERY AND CAUSED A PROCEDURE DELAY OF LESS THAN 15 MINUTES. THE PROCEDURE WAS COMPLETED USING A BACKUP INSTRUMENT WITH NO ADVERSE EFFECT OR INJURY TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16925267 ↗
• InjuryMay 13, 2023Break; Break

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE TIP OF THE PRECISE BIPOLAR INSTRUMENT BROKE OFF AND FELL INSIDE THE PATIENT. THE FRAGMENT WAS RETRIEVED DURING THE SAME PROCEDURE WHICH WAS COMPLETED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) OBTAINED ADDITIONAL INFORMATION ABOUT THE COMPLAINT. THE INSTRUMENT WAS INSPECTED PRIOR TO USE. THERE WERE NO CLEANING/STERILIZATION PROCESSES THAT RECENTLY CHANGED. THE PRECISE BIPOLAR INSTRUMENT WAS USED DURING THE BLADDER NECK DISSECTION. THE MONOPOLAR CURVED SCISSORS (MCS) AND PROGRASP FORCEPS INSTRUMENTS WERE IN USE WHEN THE EVENT OCCURRED. THE PRECISE BIPOLAR INSTRUMENT WAS REPLACED BY A NEEDLE DRIVER BUT IT WAS REMOVED AND REINSTALLED CORRECTLY ACCORDING TO THE SURGEON. THE PRECISE BIPOLAR INSTRUMENT'S WRIST WAS STRAIGHTENED UPON REMOVAL. THE ASSISTANT FORCEPS RETRIEVED THE FRAGMENT SAFELY. THERE WERE NO INTRA-OPERATIVE COMPLICATIONS THAT OCCURRED. THE PROCEDURE WAS COMPLETED WITH A BACKUP PRECISE BIPOLAR INSTRUMENT. ADDITIONALLY, THERE WAS NO POST-OPERATIVE COMPLICATIONS THAT OCCURRED AND THE PATIENTS CURRENT STATUS HAD A GOOD CLINICAL EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16925234 ↗
• MalfunctionSep 29, 2022Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT DURING CENTRAL PROCESSING, THE PRECISE BIPOLAR FORCEPS INSTRUMENT WAS NOTED TO HAVE BROKEN CABLE. THERE WAS NO REPORT OF PATIENT INVOLVEMENT. 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 15501768 ↗
• MalfunctionMar 9, 2022Scratched Material; Scratched Material

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED PROSTATECTOMY SURGICAL PROCEDURE, THE PRECISE BIPOLAR FORCEPS WAS FOUND TO HAVE A TORN CABLE. A BACKUP INSTRUMENT OF THE SAME KIND WAS USED TO COMPLETE THE PROCEDURE. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) HAS PERFORMED FOLLOW-UP TO REQUEST ADDITIONAL INFORMATION RELATED TO THE REPORTED EVENT. HOWEVER, AS OF THE DATE OF THIS REPORT, NO FURTHER DETAILS HAVE BEEN RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13706756 ↗
• MalfunctionDec 28, 2020Break; Material Split, Cut or Torn; Break; Material Split, Cut or Torn

  IT WAS REPORTED THAT PRIOR TO STARTING A DA VINCI-ASSISTED PROSTATECTOMY SURGICAL PROCEDURE, THE RUBBER ON THE PRECISE BIPOLAR FORCEPS INSTRUMENT WAS NOTED TO BE BROKEN. THE INSTRUMENT WAS REPLACED. THERE WAS NO REPORT OF FRAGMENT(S) FALLING INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. DUE TO THE ALLEGED ISSUE, THE PROCEDURE WAS DELAYED BY 3 MINUTES. INTUITIVE SURGICAL, INC. (ISI) HAS ATTEMPTED TO OBTAIN ADDITIONAL INFORMATION RELATED TO THE REPORTED EVENT. HOWEVER, AS OF THE DATE OF THIS REPORT, NO ADDITIONAL INFORMATION HAS BEEN PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 11084794 ↗
• MalfunctionSep 29, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  DURING A DA VINCI-ASSISTED PROSTATECTOMY WITH LYMPH NODE DISSECTION SURGICAL PROCEDURE, IT WAS REPORTED THAT THE JAW PULLEY OF THE PRECISE BIPOLAR FORCEPS WAS BROKEN. A FRAGMENT HAD FALLEN INTO THE PATIENT AND WAS RETRIEVED DURING THE SAME PROCEDURE. THE DEFECTIVE INSTRUMENT WAS REPLACED WITH A BACKUP INSTRUMENT OF THE SAME KIND. THE PROCEDURE WAS COMPLETED WITH NO REPORTED PATIENT HARM OR INJURY. DUE TO THE REPORTED ISSUE, THERE WAS A SURGICAL PROCEDURE DELAY OF 20 MINUTES. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE CUSTOMER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE INSTRUMENT BROKE AFTER 1.5 HOURS OF USE. SURGEON SUSPECTED THE FRAGMENT BROKE DUE TO A COLLISION WITH ANOTHER INSTRUMENT. THE SURGICAL STAFF SAW THE INSTRUMENT BREAK INSIDE THE PATIENT. THE SURGICAL ASSISTANT WAS ABLE TO RETRIEVE ALL OF THE FRAGMENTS. NO POST-OPERATIVE TESTS WERE PERFORMED. NO INTRA-OPERATIVE OR POST-OPERATIVE COMPLICATIONS WERE REPORTED, AND THE PATIENT WAS DISCHARGED. THE INSTRUMENT WAS INSPECTED PRIOR TO USE, AND THE WRIST WAS STRAIGHTENED PRIOR TO REMOVING THE INSTRUMENT DURING THE CASE.

  Patient problems: Device Embedded In Tissue or Plaque; No Known Impact Or Consequence To Patient

  MAUDE report 9132515 ↗