EndoWrist;daVinci Si 420278Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00886874111772), received between May 26, 2017 and Jul 27, 2021 — classified as 8 malfunctions.

The most frequently reported specific device problem is “Break” (6 reports).

1 FDA recall record name this device's identifier, 1 still open.

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.

Recalls naming this device

1. Dec 9, 2025Class IIOpen, Classified

   Due to increased complaints for broken/frayed grip cables for reusable instruments.

   Z-1699-2026 · Root cause: Process control · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 27, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED LOW ANTERIOR RESECTION SURGICAL PROCEDURE, THE GRASPING RETRACTOR INSTRUMENT HAD BROKEN CABLES AT THE TIP. THERE WAS NO REPORT OF A FRAGMENT FALLING INSIDE THE PATIENT DUE TO THIS EVENT. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) MADE MULTIPLE FOLLOW-UP ATTEMPTS 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 12229660 ↗
• MalfunctionMar 18, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A DA VINCI ASSISTED PROCEDURE, THE GRASPING RETRACTOR HAD A LOOSE WIRE. THE PROCEDURE WAS COMPLETED AND THERE WAS NO PATIENT INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE REPORTER TO REQUEST ADDITIONAL INFORMATION. HOWEVER, THE REPORTER NOTED THAT NO FURTHER DETAILS WERE AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11520287 ↗
• MalfunctionJan 11, 2021Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A DA VINCI ASSISTED PROCEDURE THE GRASPING RETRACTOR INSTRUMENT HAD BROKEN STRINGS. THE PROCEDURE WAS COMPLETED AND THERE WAS NO PATIENT INJURY. INTUITIVE SURGICAL, INC. (ISI) MADE MULTIPLE FOLLOW-UP ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION. HOWEVER, NO FURTHER DETAILS HAVE BEEN RECEIVED AS OF THE DATE OF THIS REPORT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 11145017 ↗
• MalfunctionMay 19, 2020Break; Break

  IT WAS REPORTED THAT DURING A DA VINCI ASSISTED ABDOMINOPERINEAL RESECTION, THE GRASPING RETRACTOR HAD A BROKEN CABLE. THE PROCEDURE WAS COMPLETED AND THERE WAS NO PATIENT INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE SITE DID NOT PERFORM ANY TESTS BUT PERFORMED A VISUAL INSPECTION OF THE CAVITY FOR LOOSE FRAGMENTS. THE REPORTER ALSO CONFIRMED THE SURGERY AS A COMBINATION OF LAPAROSCOPIC AND ROBOTIC ABDOMINOPERINEAL RESECTION, PERFORMED ON (B)(6) 2020.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10073396 ↗
• MalfunctionJan 9, 2019Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A DA VINCI ASSISTED TOTAL BENIGN HYSTERECTOMY SURGICAL PROCEDURE, THE 8MM GRASPING RETRACTOR 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 8231200 ↗
• MalfunctionFeb 15, 2018Break; Break

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED PARTIAL NEPHRECTOMY PROCEDURE, A BROKEN CABLE WAS NOTED AT THE ARTICULATING JAW OF THE GRASPING RETRACTOR INSTRUMENT. 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 7273245 ↗
• MalfunctionJul 24, 2017Break; Break

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE CUSTOMER NOTED A BROKEN CABLE ON THE GRASPING RETRACTOR INSTRUMENT. 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 6737481 ↗
• MalfunctionMay 26, 2017Break; Break

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED PULMONARY LOBECTOMY PROCEDURE, A CABLE AT THE WRIST OF THE GRASPING RETRACTOR INSTRUMENT BROKE. THE INSTRUMENT WAS REPLACED AND THE PROCEDURE WAS COMPLETED. 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 6594640 ↗