EndoWrist;daVinci Si 420194Recalls & reported problems

Summary

The FDA's MAUDE database contains 24 adverse event reports that list this exact device (DI 00886874111611), received between Jun 8, 2017 and Mar 2, 2026 — classified as 2 injuries, 22 malfunctions.

The most frequently reported specific device problem is “Material Split, Cut or Torn” (10 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. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. Dec 9, 2025Open, Classified

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

   Z-1698-2026 · Root cause: Process control · FDA record ↗

Most reported problems

Recent adverse event reports

The 24 most recent of 24 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 2, 2026Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING DA VINCI-ASSISTED SURGICAL PROCEDURE, MEGA NEEDLE DRIVER WAS FOUND TO HAVE BROKEN/FRAYED CABLE. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE DAMAGED PART IS METAL CABLE, BUT NOT BLACK CONDUCTOR WIRE. THE INSTRUMENT WAS INSPECTED PRIOR TO USE WITH NO ABNORMAL DAMAGE. SUTURING WAS BEING PERFORMED WHEN THE ISSUE OCCURRED. THERE WAS A PROBLEM ABOUT OPENING/CLOSING DURING THE PROCESS. NO FRAGMENT FELL INSIDE OF THE PATIENT¿S ANATOMY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24477735 ↗
• MalfunctionJan 30, 2026Material Split, Cut or Torn

  REFER TO H11 FOR FOLLOW-UP INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24228394 ↗
• MalfunctionJan 7, 2026Material Split, Cut or Torn

  REFER TO H11 FOR FOLLOW-UP INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23997633 ↗
• MalfunctionJan 7, 2026Material Split, Cut or Torn

  IT WAS REPORTED THAT THERE WAS A BROKEN CABLE WITH A DA VINCI PRODUCT. THE CUSTOMER REPORTED EVENT HAS NO REPORT OF PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23997620 ↗
• MalfunctionOct 15, 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: Insufficient Information

  MAUDE report 23294948 ↗
• MalfunctionAug 21, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT THERE WAS A BROKEN CABLE WITH A DA VINCI PRODUCT. THE CUSTOMER REPORTED EVENT HAS NO REPORT OF PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22867812 ↗
• MalfunctionJul 15, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT THERE WAS A BROKEN CABLE WITH A DA VINCI PRODUCT. THE CUSTOMER REPORTED EVENT HAS NO REPORT OF PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22514655 ↗
• MalfunctionMay 6, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT THERE WAS A BROKEN CABLE WITH A DA VINCI PRODUCT. THE CUSTOMER REPORTED EVENT HAS NO REPORT OF PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21972604 ↗
• MalfunctionMar 24, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT THERE WAS A BROKEN CABLE WITH A DA VINCI PRODUCT. THE CUSTOMER REPORTED EVENT HAS NO REPORT OF PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21682986 ↗
• MalfunctionFeb 25, 2025Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE MEGA NEEDLE DRIVER WIRE WAS ABOUT TO BREAK. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21458854 ↗
• MalfunctionDec 28, 2024Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED MITRAL VALVE REPAIR SURGICAL PROCEDURE, THE WIRE OF THE MEGA NEEDLE DRIVER INSTRUMENT WAS BROKEN. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21031438 ↗
• MalfunctionOct 16, 2024Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE MEGA NEEDLE DRIVER HAD A BROKEN WIRE. THE USER COMPLETED THE PROCEDURE USING A BACKUP MEGA NEEDLE DRIVER WITH NO FURTHER ISSUE REPORTED. NO FRAGMENT FELL INSIDE THE PATIENT. NO KNOWN IMPACT OR PATIENT CONSEQUENCE WAS REPORTED. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THERE WERE NO INSTRUMENT COLLISIONS DURING THE PROCEDURE. THERE WERE NO ISSUES RELATED TO THE OPENING/CLOSING OF THE GRIPS NOR THE HORIZONTAL/VERTICAL MOTION OF THE GRIPS/WRIST. THERE WAS NO IMPROPER MANIPULATION OF THE WRIST.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20458582 ↗
• MalfunctionMar 16, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18918874 ↗
• MalfunctionJun 17, 2023Unintended Movement; Unintended Movement

  REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17149116 ↗
• MalfunctionJun 5, 2023Unintended System Motion; Unintended System Motion

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE MEGA NEEDLE DRIVER INSTRUMENT DID NOT RESPOND TO THE SURGEON'S COMMANDS. A SIMILAR BACKUP INSTRUMENT WAS USED TO PROCEED WITH THE CASE. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17067313 ↗
• MalfunctionJun 5, 2023Unintended System Motion; Failure to Align; Unintended System Motion; Failure to Align

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE MEGA NEEDLE DRIVER HAD NON-INTUITIVE MOTION. THE CUSTOMER USED A BACKUP INSTRUMENT OF THE SAME KIND TO CONTINUE. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17067312 ↗
• MalfunctionMay 6, 2023Defective Device; Defective Device

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE MEGA NEEDLE DRIVER HAD A FRAYED WIRE AT THE TIP. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY USING A BACKUP MEGA NEEDLE DRIVER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16883428 ↗
• InjuryNov 6, 2020Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.

  Patient problems: Foreign Body In Patient; No Known Impact Or Consequence To Patient

  MAUDE report 10805668 ↗
• MalfunctionAug 14, 2020Break; Break

  IT WAS REPORTED THAT DURING A DA VINCI ASSISTED PROCEDURE, THE WIRES OF THE MEGA NEEDLE DRIVER BROKE INTRA-ABDOMINALLY. THE SURGEON WAS AWARE OF THE ISSUE AND THE INSTRUMENT WAS REMOVED SAFELY. THE INSTRUMENT WAS NOTED TO HAVE 8 REMAINING LIVES. THE PROCEDURE WAS COMPLETED WITH A BACKUP DA VINCI INSTRUMENT OF THE SAME KIND AND THERE WAS NO PATIENT INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE REPORTER STATED THAT THE PATIENT WAS A (B)(6) YEAR OLD HISPANIC FEMALE WEIGHING (B)(6) KG. ON THE DAY OF THE PROCEDURE, THE PATIENT UNDERWENT COMPLETE BLOOD CELL (CBC) TYPE AND SCREEN, AND COVID TESTS. THE PATIENT HAD A HISTORY OF ARTHRITIS, HYPERTENSION AND STRESS INCONTINENCE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10411577 ↗
• MalfunctionJul 10, 2018Break; Break

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED HYSTERECTOMY PROCEDURE, THE MEGA NEEDLE DRIVER INSTRUMENT WAS NOT MOVING INTUITIVELY. THE SURGEON THEN NOTED A BROKEN "STEEL WIRE" 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 7673617 ↗
• MalfunctionMar 23, 2018Break; Break

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE TIP OF THE MEGA NEEDLE DRIVER INSTRUMENT WAS NOTED TO BE SIDEWAYS. 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 7367299 ↗
• MalfunctionNov 13, 2017Break; Break

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED HYSTERECTOMY WITH BILATERAL SALPINGO-OOPHORECTOMY PROCEDURE, A CABLE FROM THE MEGA NEEDLE DRIVER INSTRUMENT SNAPPED AND FELL INSIDE THE PATIENT. ALL FRAGMENTS WERE RETRIEVED WITH A DA VINCI PROGRASP FORCEPS INSTRUMENT. THERE WAS NO POST-OPERATIVE TESTS PERFORMED TO CHECK FOR ANY REMAINING FRAGMENTS. THERE WAS NO REPORT OF PATIENT HARM, ADVERSE OUTCOME OR INJURY.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 7026561 ↗
• MalfunctionSep 14, 2017Break; Break

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED HYSTERECTOMY PROCEDURE, THE CUSTOMER NOTED LOOSE WIRES ON THE MEGA NEEDLE DRIVER 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 6866404 ↗
• InjuryJun 8, 2017Device Issue; Device Issue

  IT WAS INITIALLY REPORTED THAT DURING A DA VINCI-ASSISTED HYSTERECTOMY PROCEDURE, BOWEL TISSUE GOT STUCK AROUND THE CABLING OR WRIST AREA OF THE MEGA NEEDLE DRIVER INSTRUMENT. THE SURGICAL PROCEDURE WAS CONVERTED TO OPEN SURGERY IN ORDER TO REPAIR THE PATIENT'S BOWEL. ON (B)(6) 2017, INTUITIVE SURGICAL, INC. (ISI) CONTACTED THE ISI CLINICAL SALES REPRESENTATIVE (CSR) AND OBTAINED THE FOLLOWING INFORMATION REGARDING THE REPORTED EVENT: THE CSR WAS NOT PRESENT DURING THE SURGICAL PROCEDURE WHICH WAS NOT RECORDED ON VIDEO. THE CSR DID NOT KNOW WHAT SURGICAL TASK WAS BEING PERFORMED WHEN THE EVENT OCCURRED, HOW THE SURGICAL STAFF WAS ABLE TO REMOVE THE STUCK BOWEL TISSUE FROM THE INSTRUMENT'S WRIST, OR WHAT TYPE OF BOWEL INJURY THE PATIENT SUSTAINED. THE SURGEON MADE THE DECISION TO CONVERT TO OPEN SURGERY IN ORDER TO REPAIR THE PATIENT'S BOWEL. HOWEVER, THE CSR DID NOT KNOW WHAT SPECIFIC MEDICAL INTERVENTION WAS PERFORMED TO REPAIR THE PATIENT'S BOWEL. THE PLANNED HYSTERECTOMY PROCEDURE WAS COMPLETED VIA OPEN SURGERY. TO THE CSR'S KNOWLEDGE, NO POST-OPERATIVE COMPLICATIONS HAVE BEEN REPORTED.

  Patient problems: Tissue Damage

  MAUDE report 6624684 ↗