Single-Site 478115Recalls & reported problems

Summary

The FDA's MAUDE database contains 61 adverse event reports that list this exact device (DI 00886874113752), received between Aug 17, 2022 and Apr 18, 2026 — classified as 61 malfunctions.

The most frequently reported specific device problem is “Unintended System Motion” (33 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 16, 2026.

Recalls naming this device

1. Oct 6, 2023Open, Classified

   There is the potential for the needle drive to become dislodged and/or broken which could result in uncontrollable movement.

   Z-0406-2024 · Root cause: Process control · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 61 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 18, 2026Material Split, Cut or Torn

  REFER TO H11 FOR FOLLOW-UP INFORMATION.

  Patient problems: Insufficient Information

  MAUDE report 24919907 ↗
• MalfunctionApr 1, 2026Material Split, Cut or Torn

  REFER TO H11 FOR FOLLOW-UP INFORMATION.

  Patient problems: Insufficient Information

  MAUDE report 24750969 ↗
• MalfunctionApr 1, 2026Material Split, Cut or Torn

  REFER TO H11 FOR FOLLOW-UP INFORMATION.

  Patient problems: Insufficient Information

  MAUDE report 24750954 ↗
• MalfunctionMar 30, 2026Material Split, Cut or Torn

  REFER TO H11 FOR FOLLOW-UP INFORMATION.

  Patient problems: Insufficient Information

  MAUDE report 24722512 ↗
• MalfunctionMar 25, 2026Material Split, Cut or Torn

  REFER TO H11 FOR FOLLOW-UP INFORMATION.

  Patient problems: Insufficient Information

  MAUDE report 24684274 ↗
• MalfunctionMar 11, 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: Insufficient Information

  MAUDE report 24573670 ↗
• MalfunctionMar 11, 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: Insufficient Information

  MAUDE report 24566046 ↗
• MalfunctionMar 3, 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: Insufficient Information

  MAUDE report 24502669 ↗
• MalfunctionFeb 13, 2026Material Split, Cut or Torn

  REFER TO H11 FOR FOLLOW-UP INFORMATION.

  Patient problems: Insufficient Information

  MAUDE report 24339161 ↗
• MalfunctionFeb 13, 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: Insufficient Information

  MAUDE report 24330019 ↗
• MalfunctionJan 9, 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: Insufficient Information

  MAUDE report 24017213 ↗
• MalfunctionDec 9, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  REFER TO H11 FOR FOLLOW-UP INFORMATION.

  Patient problems: Insufficient Information

  MAUDE report 23753619 ↗
• MalfunctionSep 5, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE SINGLE SITE WRISTED NEEDLE DRIVER INSTRUMENT WAS OBSERVED TO HAVE A BROKEN CABLE. THE PROCEDURE WAS COMPLETED. THERE WERE NO REPORTS OF PATIENT INJURY.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 22984539 ↗
• MalfunctionJul 18, 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 22548983 ↗
• MalfunctionJul 18, 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 22548958 ↗
• MalfunctionJul 14, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  REFER TO H11 FOR FOLLOW-UP INFORMATION.

  Patient problems: Insufficient Information

  MAUDE report 22502133 ↗
• MalfunctionApr 25, 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 21914315 ↗
• MalfunctionNov 16, 2024Break; Break

  REFER TO H11 FOR FOLLOW-UP INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20701209 ↗
• MalfunctionAug 26, 2024Unintended System Motion; Unintended System Motion

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED MYOMECTOMY SURGICAL PROCEDURE, THE CUSTOMER NOTICED THAT THE WRISTED NEEDLE DRIVER INSTRUMENT MOVED IN A DIFFERENT DIRECTION THAN INTENDED. THE INSTRUMENT WAS NOT USED ON THE PATIENT. THE INSTRUMENT WAS REMOVED AND REPLACED WITH A BACKUP. FOLLOWING THIS, THE USER CONTINUED AND COMPLETED THE PROCEDURE WITH NO FURTHER ISSUES. NO FRAGMENT FELL INTO THE PATIENT. NO KNOWN IMPACT OR PATIENT CONSEQUENCE WAS REPORTED. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED ADDITIONAL INFORMATION: THE REPORTER CONFIRMED THAT THE INSTRUMENT MOVED IN THE OPPOSITE DIRECTION. THE ISSUE DID NOT OCCUR WITH THE SURGEON'S HEAD INSIDE THE SURGEON CONSOLE¿S HIGH-RESOLUTION STEREO VIEWER. THE ISSUE DID NOT OCCUR WHILE THE SURGEON WAS ATTEMPTING TO MANIPULATE INSTRUMENTS FROM THE SURGEON CONSOLE. THERE WAS NO SHAKINESS AND/OR FRICTION EXPERIENCED/OBSERVED. THERE WAS NO INSTRUMENT-TO-INSTRUMENT OR SYSTEM ARM-TO-ARM INTERFERENCE. THE ISSUE WAS PERSISTENT. THE REPORTER WAS UNABLE TO DISCLOSE THE PATIENT DEMOGRAPHIC INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20072941 ↗
• MalfunctionFeb 6, 2024Unintended System Motion; Unintended System Motion

  REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18656017 ↗
• MalfunctionJan 23, 2024Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED MYOMECTOMY SURGICAL PROCEDURE, THE WRISTED NEEDLE DRIVER INSTRUMENT MOVED TO THE OPPOSITE DIRECTION. THERE WAS NO REPORT OF FRAGMENT(S) FALLING INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITH A BACKUP INSTRUMENT OF SAME KIND. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE INSTRUMENT WAS INSPECTED PRIOR TO USE WITH NO ABNORMALITY. THE ISSUE OCCURRED PERSISTENTLY WHILE THE SURGEON¿S HEAD WAS INSIDE THE SURGEON CONSOLE (SC)¿S HIGH RESOLUTION STEREO VIEWER AND THE SURGEON WAS ATTEMPTING TO MANIPULATE INSTRUMENTS FROM THE SC. THE TIMING OF INSTRUMENT MOVEMENT WAS APPROPRIATE. THERE WAS NO INSTRUMENT-TO-INSTRUMENT OR SYSTEM ARM-TO-ARM INTERFERENCE. NO SHAKINESS, FRICTION, OR EXTERNAL COLLISIONS OCCURRED. THERE WAS NO INJURY TO THE PATIENT AS RESULT OF THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18566953 ↗
• MalfunctionJan 20, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SUBTOTAL GASTRECTOMY SURGICAL PROCEDURE, THE WRISTED NEEDLE DRIVER (WND) HAD A BROKEN WIRE. NO FRAGMENT FELL INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED AS PLANNED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE INSTRUMENT WAS INSPECTED PRIOR TO USE WITH NO ISSUE. SUTURE WAS BEING PERFORMED WHEN THE ISSUE OCCURRED. THE INSTRUMENT DID NOT COLLIDE WITH OTHER INSTRUMENT OR TOOL DURING THE PROCEDURE. THERE WAS NO FRAGMENT FALLING INTO THE PATIENT¿S ANATOMY. THE CUSTOMER USED A BACKUP INSTRUMENT TO CONTINUE WITH THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18548606 ↗
• MalfunctionJan 18, 2024Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED MYOMECTOMY SURGICAL PROCEDURE, THE WRISTED NEEDLE DRIVER INSTRUMENT JAWS WERE NOT OPENED DUE TO A BROKEN CABLE. A BACKUP INSTRUMENT WAS USED. NO KNOWN IMPACT OR PATIENT CONSEQUENCE WAS REPORTED. PROCEDURE WAS COMPLETED. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE INSTRUMENT WAS INSPECTED PRIOR TO USE, AND NO DAMAGE WAS FOUND. THE CUSTOMER INDICATED THAT A CABLE WAS FOUND PROTRUDING FROM THE DISTAL END OF THE INSTRUMENT WHILE SUTURING THE TISSUE AND THE ISSUE WAS RELATED TO THE OPENING, CLOSING OF THE GRIPS. THE INSTRUMENT JAW WAS NOT GRASPING ON TISSUE WHEN THE ISSUE OCCURRED. THERE WERE NO ISSUES WITH LEFT, RIGHT MOTION OF THE GRIPS OR UP, DOWN MOTION OF THE WRIST. THE INSTRUMENT DID NOT COLLIDE WITH ANY OTHER INSTRUMENT OR TOOL DURING THE PROCEDURE. THE PROCEDURE WAS COMPLETED WITH NO REPORT OF FRAGMENT(S) FALLING INSIDE THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18532460 ↗
• MalfunctionNov 22, 2023Unintended System Motion; Unintended System Motion

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED MYOMECTOMY SURGICAL PROCEDURE, THE WRISTED NEEDLE DRIVER INSTRUMENT HAD AN UNUSUAL MOVEMENT. THERE WAS NO REPORT OF FRAGMENT(S) FALLING INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITH A BACKUP INSTRUMENT OF THE SAME KIND. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THIS IS A RECALL PART. THE INSTRUMENT WAS INSPECTED PRIOR TO USE WITH NO ABNORMALITY. THE CUSTOMER OBSERVED THAT THE MOVEMENT OF THE TIP WAS WEAK PERSISTENTLY. NO REPORT THAT THE INSTRUMENT MOVED IN UNCONTROLLED MOTION OR THE OPPOSITE DIRECTION. THE ISSUE OCCURRED WHILE THE SURGEON¿S HEAD WAS INSIDE THE SURGEON CONSOLE (SC)¿S HIGH RESOLUTION STEREO VIEWER AND THE SURGEON WAS ATTEMPTING TO MANIPULATE INSTRUMENTS FROM THE SC. NO SHAKINESS, FRICTION, OR EXTERNAL COLLISIONS OCCURRED. THE MOVEMENTS OF THE SURGEON SCALED APPROPRIATELY TO THE INSTRUMENT AND THE TIMING OF INSTRUMENT MOVEMENT WAS APPROPRIATE. NO KNOWN IMPACT OR PATIENT CONSEQUENCE WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18196524 ↗
• MalfunctionOct 13, 2023Unintended System Motion; Unintended System Motion

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED MYOMECTOMY SURGICAL PROCEDURE, THE TIP OF THE WRISTED NEEDLE DRIVER INSTRUMENT TIP HAD NO SUFFICIENT MOVEMENT. A BACKUP INSTRUMENT OF SAME KIND WAS USED TO CONTINUE THE PROCEDURE. THERE WAS NO REPORT OF FRAGMENT(S) FALLING INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITH NO REPORT OF PATIENT INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE WRISTED NEEDLE DRIVER INSTRUMENT WAS INSPECTED PRIOR TO USE WITH NO ABNORMALITY. THE CUSTOMER CONFIRMED THAT THE INSTRUMENT JAW MOVEMENT DID NOT MATCH THE ACTION INTENDED BY THE SURGEON PERSISTENTLY. THE ISSUE OCCURRED WHILE THE SURGEON¿S HEAD WAS INSIDE THE SURGEON CONSOLE (SC)¿S HIGH RESOLUTION STEREO VIEWER AND THE SURGEON WAS ATTEMPTING TO MANIPULATE INSTRUMENTS FROM THE SSC. THE TIMING OF INSTRUMENT MOVEMENT WAS NOT APPROPRIATE. NO SHAKINESS/ FRICTION/ EXTERNAL COLLISIONS WAS EXPERIENCED/OBSERVED. THERE WAS NO INSTRUMENT-TO-INSTRUMENT OR SYSTEM ARM-TO-ARM INTERFERENCE. THE DRAPE NUMBER WAS UNKNOWN, AND THE DRAPE WOULD NOT BE RETURNED. THERE WAS NO INJURY TO THE PATIENT AS RESULT OF THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17936346 ↗