EndoWrist;daVinci Si 420117Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00886874111369), received between Jun 16, 2022 and May 6, 2023 — classified as 2 malfunctions.

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

• MalfunctionMay 6, 2023Peeled/Delaminated; Peeled/Delaminated

  IT WAS REPORTED THAT AFTER A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE NEEDLE DRIVER INSTRUMENT PRESENTED A LOSS OF INTEGRITY IN ITS EXTENSION (PEELED). THE PROCEDURE WAS COMPLETED WITH THE SAME INSTRUMENT WITH NO REPORTED INJURY.

  Patient problems: Insufficient Information

  MAUDE report 16883468 ↗
• MalfunctionJun 16, 2022Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED PULMONARY LOBECTOMY SURGICAL PROCEDURE, THE NEEDLE DRIVER INSTRUMENT'S BODY WAS DAMAGED; IT WAS PEELING AND EXPOSED THE METALLIC PART OF THE CLAMP. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY BY RESEATING THE SAME INSTRUMENT. INTUITIVE SURGICAL, INC. (ISI) HAS PERFORMED FOLLOW-UP TO OBTAIN ADDITIONAL INFORMATION. HOWEVER, NO FURTHER DETAILS HAVE BEEN RECEIVED AS OF THE DATE OF THIS REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14710337 ↗