EndoWrist;daVinci Si 420190Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00886874111598), received between May 30, 2018 and May 21, 2023 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Break” (4 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 21, 2023Break; Break

  IT WAS REPORTED THAT DURING A DA VINCI ASSISTED PROCEDURE, A PORTION OF THE COBRA GRASPER WAS MISSING. THE MISSING PIECE DID NOT FALL OFF DURING PROCEDURE. WHEN THE CUSTOMER TRIED TO USE THE INSTRUMENT, THEY NOTICED PART WAS MISSING. THE PROCEDURE WAS COMPLETED ND THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16971236 ↗
• MalfunctionJun 6, 2019Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING CENTRAL PROCESSING, THE 8 MM COBRA GRASPER INSTRUMENT WAS FOUND TO HAVE A BROKEN CABLE. THERE WAS NO REPORT OF PATIENT INVOLVEMENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8675300 ↗
• MalfunctionJul 12, 2018Break; Break

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED MYOMECTOMY PROCEDURE, THE SURGEON NOTED A BROKEN "STEEL WIRE" ON THE COBRA GRASPER INSTRUMENT AND REPLACED THE INSTRUMENT TO COMPLETE THE PROCEDURE. THERE WAS NO REPORT OF FRAGMENTS FALLING INSIDE THE PATIENT, PATIENT HARM, ADVERSE OUTCOME OR INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7683922 ↗
• MalfunctionMay 30, 2018Break; Break

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE CUSTOMER NOTED THAT THE COBRA GRASPER INSTRUMENT HAD A BROKEN WIRE. 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 7553997 ↗