EndoWrist;daVinci Si 420309Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00886874111796), received between Jan 23, 2017 and Sep 25, 2024 — classified as 2 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Break” (5 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 25, 2024Material Fragmentation; Material Fragmentation

  REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20298328 ↗
• MalfunctionAug 28, 2024Material Fragmentation; Material Fragmentation

  REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20082762 ↗
• InjuryOct 26, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.

  Patient problems: Foreign Body In Patient

  MAUDE report 18015829 ↗
• MalfunctionMay 28, 2023Difficult to Open or Close; Difficult to Open or Close

  IT WAS REPORTED THAT DURING CENTRAL PROCESSING, THE MEGA SUTURECUT NEEDLE DRIVER WAS STUCK AND WOULD NOT FLEX. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17016014 ↗
• InjurySep 4, 2020Break; Break

  REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 10497824 ↗
• MalfunctionJan 21, 2020Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE TIP OF THE MEGASUTURECUT NEEDLE DRIVER INSTRUMENT BROKE AND FELL INSIDE THE PATIENT. THE CUSTOMER RETRIEVED THE FRAGMENT DURING THE SAME PROCEDURE. A BACKUP INSTRUMENT OF THE SAME TYPE WAS USED TO COMPLETE THE PROCEDURE WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE OPERATING ROOM (OR) NURSE AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE TIP BROKE WHILE TYING A SUTURE. THE CUSTOMER DID NOT FIND THE TIP INSIDE THE PATIENT INITIALLY, BUT LATER THE BROKEN TIP WAS FOUND AND RETRIEVED. THE CUSTOMER REPORTED THE FRAGMENT SEEMED TO COME WITH THE INSTRUMENT WHEN THE INSTRUMENT WAS REMOVED FROM THE PATIENT. ALL FRAGMENTS WERE RETRIEVED AND THERE WAS NO ADDITIONAL SURGICAL PROCEDURE REQUIRED TO REMOVE THE FRAGMENT. THE CUSTOMER DID NOT PERFORM ANY POST-OPERATIVE TESTS TO CHECK FOR REMAINING FRAGMENTS. THE INSTRUMENT WAS USED FOR ABOUT HALF AN HOUR PRIOR TO THE ISSUE. THE INSTRUMENT WAS INSPECTED PRIOR TO USE. THERE WAS NO ISSUE WITH THE FUNCTIONALITY OF THE INSTRUMENT AND THE INSTRUMENT DID NOT COLLIDE WITH ANY OTHER INSTRUMENTS OR OTHER HARD MATERIAL DURING THE SURGICAL PROCEDURE. T

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

  MAUDE report 9612932 ↗
• MalfunctionMay 23, 2019Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A DA VINCI ASSISTED SURGICAL PROCEDURE, THE MEGA SUTURECUT NEEDLE HAD A BROKEN CABLE. THERE WAS NO REPORT OF FRAGMENT(S) FALLING INSIDE THE PATIENT, PATIENT HARM, ADVERSE OUTCOME OR INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8637962 ↗
• MalfunctionJun 6, 2018Break; Break

  IT WAS REPORTED THAT PRIOR TO THE START OF A DA VINCI-ASSISTED TOTAL BENIGN HYSTERECTOMY PROCEDURE, THE MEGA SUTURE CUT INSTRUMENT COULD NOT BE RECOGNIZED BY THE SYSTEM. THERE WAS NO REPORT OF FRAGMENT(S) FALLING INSIDE THE PATIENT, PATIENT HARM, ADVERSE OUTCOME OR INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7574997 ↗
• MalfunctionJan 23, 2017Break; Detachment Of Device Component; Break; Detachment Of Device Component

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, BROKEN CABLES WERE OBSERVED ON THE MEGA SUTURECUT NEEDLE DRIVER INSTRUMENT. THERE WAS NO REPORT OF FRAGMENTS FALLING INTO THE PATIENT, PATIENT HARM, ADVERSE OUTCOME OR INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6270796 ↗