EndoWrist;daVinci Si 420189Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 00886874111581), received between Apr 7, 2017 and Sep 10, 2025 — classified as 1 injury, 15 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-1697-2026 · Root cause: Process control · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 10, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  REFER TO H11 FOR FOLLOW-UP INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23021789 ↗
• MalfunctionSep 10, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT THE CUSTOMER EXPERIENCED AN ISSUE WITH AN INTUITIVE PRODUCT. THE CUSTOMER REPORTED EVENT HAS NO REPORT OF PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23021722 ↗
• MalfunctionSep 10, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT THE CUSTOMER EXPERIENCED AN ISSUE WITH AN INTUITIVE PRODUCT. THE CUSTOMER REPORTED EVENT HAS NO REPORT OF PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23021717 ↗
• MalfunctionSep 10, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  REFER TO H11 FOR FOLLOW-UP INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23021694 ↗
• MalfunctionSep 10, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT THE CUSTOMER EXPERIENCED AN ISSUE WITH AN INTUITIVE PRODUCT. THE CUSTOMER REPORTED EVENT HAS NO REPORT OF PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23021690 ↗
• MalfunctionSep 10, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  REFER TO H11 FOR FOLLOW-UP INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23021681 ↗
• MalfunctionJun 5, 2023Unintended System Motion; Difficult to Remove; Unintended System Motion; Difficult to Remove

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE DOUBLE FENESTRATED GRASPER INSTRUMENT WAS UNABLE TO BE REMOVED FROM THE ARM AND HAD TO BE REMOVED WITH FORCE. THE PROCEDURE WAS COMPLETED WITH A BACKUP INSTRUMENT AND THERE WAS NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17067239 ↗
• MalfunctionMar 22, 2023Unintended System Motion; Unintended System Motion

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED LOW ANTERIOR RESECTION SURGICAL PROCEDURE, THE USER OBSERVED NON-INTUITIVE MOVEMENT (MOVED IN THE OPPOSITE DIRECTION) ON THE INSTRUMENT INSTALLED ON PATIENT SIDE MANIPULATOR (PSM) ARM 3. THE CUSTOMER RECEIVED PHONE ASSISTANCE FROM THE TECHNICAL SUPPORT ENGINEER (TSE). TROUBLESHOOTING WAS PERFORMED BY TESTING THE SAME INSTRUMENT INTO ANOTHER PSM ARM; HOWEVER, THE ISSUE PERSISTED. REVIEW OF THE SITE¿S SYSTEM LOGS IDENTIFIED NO RELATED ERROR. THE SURGEON ELECTED TO CONTINUE WITH THE PROCEDURE. AT AN UNSPECIFIED TIME, CUSTOMER CALLED BACK AND INFORMED THAT THE SAME INSTRUMENT WAS RETESTED, AND THE SAME ISSUE WAS OBSERVED. THE USER STOPPED USING THE AFFECTED INSTRUMENT. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE SITE AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT: AN INSPECTION AND CHECK WAS CONDUCTED ON THE SYSTEM AND THE INSTRUMENT PRIOR TO USE. THE INSTRUMENTS WORKED INITIALLY. THE DOUBLE FENESTRATED GRASPER INSTRUMENT EXHIBITED AN ISSUE, AND IT WAS REPLACED WITH A BACKUP INSTRUMENT. THE PROCEDURE WAS COMPLETED USING ALL PSM ARMS. NO KNOWN IMPACT OR PATIENT CONSEQUENCE WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16593217 ↗
• InjuryMar 24, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED PULMONARY SEGMENTECTOMY SURGICAL PROCEDURE, THE ROBOTIC INSTRUMENT TIP ARTICULATED AND DANGLED. SURGEON HAD TO CUT THE TIP OFF OF IT IN ORDER TO REMOVE IT OUT OF THE PATIENT. INSTRUMENT FRAGMENTS REPORTEDLY FELL INSIDE THE PATIENT, BUT ALL PIECES WERE RETRIEVED WITHOUT INJURY. THE PROCEDURE WAS COMPLETED AS PLANNED WITH NO REPORTED INJURY. ON 23-FEB-2022, INTUITIVE SURGICAL, INC (ISI) RECEIVED USER FACILITY REPORT (B)(4) STATING: "ROBOTIC INSTRUMENT TIP ARTICULATED AND DANGLED. SURGEON HAD TO CUT THE TIP OFF OF IT IN ORDER TO REMOVE IT OUT OF THE PATIENT. ALL PIECES WERE RETRIEVED WITHOUT INJURY." ON (B)(6) 2022, ISI SPOKE TO THE RISK MANAGER AND OBTAINED THE FOLLOWING INFORMATION: THE PART NUMBER WAS 420189-11 AND IT WAS FOR A DOUBLE FENESTRATED GRASPER INSTRUMENT. SHE DID NOT KNOW WHERE THE INSTRUMENT WAS CURRENTLY, BUT WILL LOOK AROUND TO SEE IF IT IS IN THE RISK MANAGEMENT OFFICE (SHE RETURNS IN THE OFFICE LATER THIS WEEK). THERE WAS NO MENTION OF THE INSTRUMENT COLLIDING WITH ANOTHER INSTRUMENT OR WITH A HARD OBJECT INSIDE THE PATIENT. THE SURGEON WAS ARTICULATING THE INSTRUMENT WHEN IT BROKE. SHE DID NOT KNOW IF THE INSTRUMENT W

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13887598 ↗
• MalfunctionOct 5, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED PROSTATECTOMY SURGICAL PROCEDURE, THE DOUBLE FENESTRATED GRASPER INSTRUMENT WAS BROKEN. A BACKUP INSTRUMENT OF THE SAME TYPE WAS USED AND THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE CUSTOMER WHO PROVIDED A PHOTOGRAPH OF THE INSTRUMENT. THE IMAGE INDICATED THAT THE ISSUE WAS LIKELY A BROKEN CABLE, BUT COULD NOT BE CONFIRMED WITHOUT EVALUATION OF THE RETURNED INSTRUMENT. NO FURTHER DETAILS RELATED TO THE EVENT HAVE BEEN RECEIVED AS OF THE DATE OF THIS REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12580017 ↗
• MalfunctionJan 4, 2019Break; Break

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE INSTRUMENT WAS "OUT OF CONTROLLED DURING PROCEDURE". IT WAS IDENTIFIED THAT THE WIRE OF THE DOUBLE FENESTRATED GRASPER INSTRUMENT WAS LOOSE AND BROKEN. 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 8216009 ↗
• MalfunctionSep 26, 2018Break; Break

  IT WAS REPORTED THAT PRIOR TO THE START OF A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE DOUBLE FENESTRATED GRASPER INSTRUMENT HAD AN "EXPOSED WIRE". THERE WAS NO REPORT FRAGMENTS FALLING INSIDE THE PATIENT, PATIENT HARM, ADVERSE OUTCOME OR INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7910614 ↗
• MalfunctionJul 13, 2018Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED PULMONARY WEDGE RESECTION PROCEDURE, THE DOUBLE FENESTRATED GRASPER 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 7687798 ↗
• MalfunctionJun 26, 2018Break; Detachment Of Device Component; Break; Detachment Of Device Component

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED ILEAL CONDUIT PROCEDURE, THE DOUBLE FENESTRATED GRASPER INSTRUMENT HAD "INSUFFICIENT" GRIP. 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 7639853 ↗
• MalfunctionMay 1, 2018Break; Detachment Of Device Component; Break; Detachment Of Device Component

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE CUSTOMER FELT THE DOUBLE FENESTRATED GRASPER INSTRUMENT WAS "OUT OF CONTROL". WHEN THE INSTRUMENT WAS REMOVED, A LOOSE AND BROKEN WIRE WAS NOTED. 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 7478438 ↗
• MalfunctionApr 7, 2017Break; Break

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, A CABLE AT THE DISTAL TIP OF THE DOUBLE FENESTRATED GRASPER INSTRUMENT WAS OBSERVED TO BE FRAYED. THERE WAS NO REPORT THAT ANY FRAGMENT(S) FROM THE INSTRUMENT FELL INTO A PATIENT DURING THE SURGICAL PROCEDURE AND THERE WAS NO REPORT OF PATIENT HARM, ADVERSE OUTCOME OR INJURY. THE PLANNED SURGICAL PROCEDURE WAS COMPLETED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6474352 ↗