EndoWrist;daVinci Si 410299Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00886874111109), received between Jan 29, 2019 and Jun 1, 2023 — classified as 2 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 1, 2023Break; Break

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SIGMOID COLECTOMY SURGICAL PROCEDURE THE SUCTION IRRIGATOR BROKE AND THE CUSTOMER WAS UNABLE TO REMOVE THE IRRIGATOR NORMALLY. THE CUSTOMER REMOVED THE INSTRUMENT AND CANNULA, AND WAS ABLE TO GET THE INSTRUMENT OUT, BUT FURTHER DAMAGE WAS DONE TO THE INSTRUMENT TO GET IT OUT. THE CUSTOMER CONTINUED WITH A NEW CANNULA AND INSTRUMENT. THE PROCEDURE WAS COMPLETING AS PLANNED WITH NO REPORTED INJURY. THE CLINICAL SALES REPRESENTATIVE INFORMED THAT THE SUCTION IRRIGATOR INSTRUMENT WAS WORKING FINE, THEN THE SURGICAL TECH PULLED THE INSTRUMENT TO INSTALL A DIFFERENT TYPE OF INSTRUMENT INTO THE ARM. WHEN THE SURGICAL TECH WANTED TO PLACE THE SUCTION IRRIGATOR INSTRUMENT BACK ON TO THE ARM, IT WOULD NOT GO THROUGH THE REDUCER. AT THAT TIME, THE TECH OBTAINED A NEW REDUCER AND PLACED THE SUCTION IRRIGATOR INSTRUMENT IN, HOWEVER, NOTICED THAT IT BECAME STUCK. THE SURGICAL TECH REMOVED THE TROCAR, INSTRUMENT TOGETHER, AND WAS ABLE TO RELEASE THE INSTRUMENT. WHEN THE INSTRUMENT WAS REMOVED, IT WAS OBSERVED THE INSTRUMENT WAS BROKEN AT THE HINGES. IT WAS CONFIRMED THAT NO FRAGMENTS FELL INTO THE PATIENT. THE PROCEDURE WAS COMPLETED ROBOTICALLY WIT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17038569 ↗
• MalfunctionJan 29, 2019Break; Break

  IT WAS REPORTED DURING A DA VINCI-ASSISTED LOWER ANTERIOR RESECTION PROCEDURE THAT TIP OF THE ENDOWRIST SUCTION IRRIGATOR TIP FELL OFF THE INSTRUMENT IN PATIENT'S ABDOMEN. THE TIP WAS RETRIEVED AND THE PROCEDURE COMPLETED WITH NO REPORT OF PATIENT INJURY NOR HARM. FOLLOW-UP: ON 1/28/2019, THE SITE ROBOTICS COORDINATOR (ROCO) WAS CONTACTED AND ADDITIONAL INFORMATION WAS OBTAINED ABOUT THE COMPLAINT: ROCO INDICATED SHE DOES NOT HAVE A RECORD OF SENDING THE INSTRUMENT FOR RMA THEREFORE IT MAY STILL BE WITH THEIR RISK MANAGEMENT DEPARTMENT. ROCO CONFIRMED THE BROKEN FRAGMENT WAS RETRIEVED DURING THE SAME PROCEDURE AND THERE IS NO REPORT OF PATIENT INJURY NOR HARM.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 8287492 ↗