EndoWrist;daVinci Si 420142 (UDI 00886874111406)Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00886874111406), received between Jun 13, 2021 and Dec 24, 2025 — classified as 6 malfunctions.

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

• MalfunctionDec 24, 2025Break; Break

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED MALIGNANT TONGUE BASE RESECTION SURGICAL PROCEDURE, THE 5MM MONOPOLAR CAUTERY INSTRUMENT WAS FOUND TO HAVE A BROKEN TIP. THE PROCEDURE WAS COMPLETED WITH NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23889810 ↗
• MalfunctionOct 20, 2023Unintended Movement; Material Split, Cut or Torn; Unintended Movement; Material Split, Cut or Torn

  IT WAS REPORTED THAT AFTER CENTRAL PROCESSING, WHILE PREPARING INSTRUMENTS FOR THE CASE PLANNED, IT IS FOUND THAT MONOPOLAR CAUTERY INSTRUMENT WAS HAVING RIGID MOVEMENT AND SNAKE WRIST WAS NOT MOVING FREELY TO ALL DIRECTION WHILE PHYSICALLY MOVING THE SAME. THE INSTRUMENT WAS NOT INSTALLED AND ALTERNATE INSTRUMENT WAS USED FOR THE PROCEDURE. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE CLINICAL SALES REPRESENTATIVE (CSR) INFORMED THAT THE ISSUE WAS NOTICED BEFORE THE START OF THE PROCEDURE. THE PORTS WERE NOT PLACED ON THE PATIENT. THE INSTRUMENT WAS NOT USED AS IT WAS HAVING RIGID MOVEMENTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17980960 ↗
• MalfunctionMay 27, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, A MONOPOLAR CAUTERY INSTRUMENT WAS BENT OUT OF SHAPE AND STUCK ON THE CANNULA. A BACKUP INSTRUMENT WAS USED. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17015565 ↗
• MalfunctionAug 18, 2022Thermal Decomposition of Device; Arcing; Thermal Decomposition of Device; Arcing

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED PARTIAL NEPHRECTOMY SURGICAL PROCEDURE, THE TIP OF THE MONOPOLAR CAUTERY INSTRUMENT WAS FOUND TO HAVE BURN SIGNS. THE MONOPOLAR CAUTERY SPATULA INSTRUMENT AND THE TIP OF THE MONOPOLAR CAUTERY INSTRUMENT WERE BOTH SLIGHTLY BURNT. 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). ISI FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION ON 28-JULY-2022: THE MONOPOLAR CAUTERY INSTRUMENT WAS INSPECTED PRIOR TO USE AND HAD NO DAMAGE. THE ARCING WAS OBSERVED DURING PROCEDURE AND THE INSTRUMENT WAS FOUND TO HAVE BURN SIGNS. THE CANNULA WAS INSPECTED PRIOR TO USE WITH A PIN GAUGE. THE ISSUE WAS OCCURRED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15254910 ↗
• MalfunctionMay 8, 2022Thermal Decomposition of Device; Arcing; Thermal Decomposition of Device; Arcing

  IT WAS REPORTED THAT DURING CENTRAL PROCESSING, THE MONOPOLAR CAUTERY INSTRUMENT TIP WAS FOUND MELTED AND CHARRED. IT WAS REMOVED FROM SERVICE AND REPLACED. THERE WAS NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) OBTAINED THE FOLLOWING INFORMATION ABOUT THE COMPLAINT: THERE WAS NOTHING ABNORMAL AT THE VISUAL INSPECTION ON THE STERILE FIELD. NO ARCING WAS OBSERVED. THE MONOPOLAR CORD WAS NOT CONNECTED TO A BIPOLAR INSTRUMENT. THE CUSTOMER USED CONMED SYSTEM 5000 GENERATOR WITH SETTINGS: CUT: 40, COAG: 40, BIP 35. THE MONOPOLAR SCISSORS WERE USED DURING 90% OF CASE WITH THE MARYLAND BIPOLAR FORCEPS. OFTEN DURING THE DISSECTION, THE TIPS WERE COVERED IN CARBONIZED TISSUE REQUIRING BEING REMOVED AND CLEANED. THERE WAS NO PATIENT HARM AND THE SURGERY COMPLETED AS PLANNED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14332357 ↗
• MalfunctionJun 13, 2021Failure to Deliver Energy; Failure to Deliver Energy

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE MONOPOLAR CAUTERY INSTRUMENT DID NOT WORK WHEN USED TO COAGULATE. THE CUSTOMER CHANGED THE CAUTERY CABLE, TURNED THE GENERATOR OFF AND ON, AND RECONNECTED THE CAUTERY CABLE WITH NO RESOLVE. THE PROCEDURE WAS REPORTEDLY COMPLETED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP ON 20-APR-2021 AND 1-JUN-2021 AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE PROCEDURE WAS COMPLETED USING A BACKUP INSTRUMENT WITH ABOUT 20 MINUTES DELAY. THE PROCEDURE DELAY DID NOT OCCUR DURING A WARM ISCHEMIA TIME. THE PATIENT-RELATED INFORMATION COULD NOT BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11989307 ↗