EndoWrist;daVinci Si 420275Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00886874111765), received between Feb 24, 2023 and Aug 7, 2025 — classified as 1 injury, 5 malfunctions.

The most frequently reported specific device problem is “Break” (2 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 7, 2025Break; Break

  REFER TO H11 FOR FOLLOW-UP INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22744529 ↗
• MalfunctionAug 7, 2024Break; Corroded; Break; Corroded

  IT WAS REPORTED THAT PRIOR TO THE START OF A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE HARMONIC ACE INSTRUMENT HAD A PRODUCT BREAKAGE. A BACKUP INSTRUMENT OF THE SAME KIND WAS USED TO COMPLETE THE PROCEDURE WITH NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19925731 ↗
• MalfunctionJul 12, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE HARMONIC ACE INSTRUMENT WAS NOTED TO HAVE AN ISSUE. THERE WAS NO REPORT OF PATIENT INVOLVEMENT.

  Patient problems: Insufficient Information

  MAUDE report 19727630 ↗
• MalfunctionMay 21, 2023Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT DURING CENTRAL PROCESSING, THE HARMONIC ACE INSTRUMENT WAS STERILIZED; HOWEVER, AT THE END OF THE PROCESS, THE TRAY WAS REMOVED AND THE INSTRUMENT WAS FOUND TO BE JAMMED AND BROKEN. THERE WAS NO REPORT OF PATIENT INVOLVEMENT OR REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16971286 ↗
• InjuryApr 7, 2023Unintended System Motion; Unintended System Motion

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED TOTAL GASTRECTOMY PROCEDURE, THE PATIENT EXPERIENCED A SPLENIC ARTERIAL RUPTURE. THE ISSUE OCCURRED WHEN PATIENT SIDE MANIPULATOR (PSM) #1 INSTALLED WITH HARMONIC ACE CURVED SHEARS INSTRUMENT EXPERIENCED INTERMITTENT NON-INTUITIVE MOTION 20 MINUTES BEFORE THE END OF THE PROCEDURE. THE PSM COULD NOT MOVE NORMALLY. THE CAUSE OF THE BLEEDING COULD NOT BE IDENTIFIED BUT WAS REPORTEDLY AN UNEXPECTED PART OF THE PROCEDURE. THE BLEEDING IS NOT BELIEVED TO BE RELATED TO A DA VINCI INSTRUMENT OR ACCESSORY. THE HOSPITAL THINKS THE COMPLICATION HAD NOTHING TO DO WITH THE AN INTUITIVE SURGICAL, INC. (ISI) DEVICE AND THEREFORE, NO PRODUCTS ARE EXPECTED FOR RETURN FOR EVALUATION. THE PATIENT¿S CURRENT STATUS IS UNKNOWN. THE SURGEON¿S HEAD WAS INSIDE THE HIGH RESOLUTION STEREO VIEWER (HRSV) OF THE SURGEON SIDE CONSOLE (SSC) WHEN THE EVENT OCCURRED. ADDITIONALLY, THE ISSUE OCCURRED WHILE THE SURGEON WAS ATTEMPTING TO MANIPULATE INSTRUMENTS FROM THE SSC. THE FAILURE WAS NOT RELATED TO AN INABILITY TO MOVE THE INSTRUMENT AT ALL. THE TIMING OF THE INSTRUMENT MOVEMENT WAS REPORTEDLY NOT APPROPRIATE. HOWEVER, IT IS UNKNOWN WHETHER THE MOVEMENTS OF THE SUR

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Rupture

  MAUDE report 16699086 ↗
• MalfunctionFeb 24, 2023Unintended System Motion; Unintended System Motion

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED TOTAL PANCREATECTOMY SURGICAL PROCEDURE, THE INTUITIVE SURGICAL, INC. (ISI) CLINICAL SALES REPRESENTATIVE (CSR) CALLED IN TO REPORT THAT THE MOVEMENT OF THE HARMONIC ACE CURVED SHEARS INSTRUMENT WAS NON-INTUITIVE ON PATIENT SIDE MANIPULATOR (PSM) 1. THE SITE HAD RESEATED THE HARMONIC ACE CURVED SHEARS INSTRUMENT AND STERILE ADAPTER INTO PSM 1, BUT THE ISSUE PERSISTED. THE INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) REVIEWED THE SYSTEM LOGS AND IDENTIFIED ERROR 31009 POINTING TO AN ISSUE WITH THE HARMONIC ACE CURVED SHEARS INSTRUMENT AND STERILE ADAPTER. THE TSE INSTRUCTED THE CUSTOMER MOVE THE HARMONIC ACE CURVED SHEARS INSTRUMENT TO PSM 2 AND THE ISSUE REMAINED. TSE ADVISED TO REPLACE THE INSTRUMENT TO THE BACKUP. THE USER COMPLETED THE PROCEDURE WITH NO FURTHER ISSUE REPORTED. NO FRAGMENT FELL INSIDE THE PATIENT. NO KNOWN IMPACT OR PATIENT CONSEQUENCE WAS REPORTED.INTUITIVE SURGICAL, INC. (ISI) PERFORMED FOLLOW-UP AND OBTAINED THE FOLLOWING ADDITIONAL/UPDATED INFORMATION REGARDING THE REPORTED EVENT: THE INSTRUMENT WAS REPORTEDLY INSPECTED PRIOR TO USE, AND NO ISSUE WAS NOTED. THE SURGEON WAS ABOUT TO DISSECT TIS

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16437759 ↗