EndoWrist;daVinci Si 420142 (UDI 00886874119136)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00886874119136), received between Jun 24, 2022 and Jun 8, 2023 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Arcing” (1 report).

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 8, 2023Arcing; Arcing

  REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17091977 ↗
• MalfunctionJul 6, 2022Thermal Decomposition of Device; Thermal Decomposition of Device

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE MONOPOLAR CAUTERY INSTRUMENT TIP WAS BURNT. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION ON (B)(6) 2022: THE MONOPOLAR CAUTERY INSTRUMENT WAS INSPECTED PRIOR TO USE AND NO ISSUES WERE NOTED. THERE WAS NO ARCING OBSERVED. THE PIN GAUGE WAS USED TO INSPECT THE CANNULA. THE MONOPOLAR CORD WAS CONNECTED TO A BIPOLAR INSTRUMENT. COVIDIEN FORCEFX GENERATOR WAS USED WITH SETTING 20 FOR CUT AND COAG. THE MONOPOLAR CAUTERY INSTRUMENT TIPS DID NOT COLLIDE WITH ANY OTHER INSTRUMENT OR TOOL DURING PROCEDURE AND DID NOT TOUCH ANY STAPLES, CLIPS OR SUTURES WHILE ENERGIZED. THE INSTRUMENT JAWS WERE NOT IMMERSED IN LIQUID OR CONTAMINATED BY CARBONIZED TISSUE (BIO DEBRIS) PRIOR TO ACTIVATING THE INSTRUMENT. THERE WAS NO PATIENT INJURY AND PATIENT HAS NOT RETURNED TO THE HOSPITAL DUE TO EXPERIENCING ANY POST-SURGICAL COMPLICATIONS AS A RESULT OF THE ARCING EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14940346 ↗
• MalfunctionJun 24, 2022Break; Break

  IT WAS REPORTED THAT PRIOR TO A DA VINCI-ASSISTED RADICAL TONSILLECTOMY SURGICAL PROCEDURE, THE TIP OF MONOPOLAR CAUTERY WAS FOUND TO BE BROKEN. A BACKUP INSTRUMENT OF THE SAME TYPE WAS USED AND THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. THE MONOPOLAR CAUTERY INSTRUMENT WITH THE 5 MM CAUTERY HOOK TIP OR 5 MM CAUTERY SPATULA TIP IS INTENDED TO BE USED WITH THE DA VINCI SP SYSTEM FOR MANIPULATING AND DISSECTING TISSUE AND COAGULATING AND TRANSECTING TISSUE USING MONOPOLAR ELECTROSURGICAL ENERGY. THE INSTRUMENT IS DESIGNED TO PROVIDE ENERGY FROM THE DESIGNATED LOCATION ON THE INSTRUMENT (THE TIP) TO THE PLANNED ANATOMICAL LOCATION WHEN USED AS INTENDED. THE ENERGY IS ACTIVATED BY PRESSING THE DESIGNATED PEDAL ON THE SURGEON SIDE CONSOLE (SSC). FOLLOW-UP HAS BEEN PERFORMED TO REQUEST ADDITIONAL INFORMATION RELATED TO THE EVENT. HOWEVER, NO FURTHER DETAILS HAVE BEEN RECEIVED AS OF THE DATE OF THIS REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14810906 ↗