EndoWrist SP 430101Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00886874124147), received between Jul 9, 2025 and Sep 28, 2026 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Break” (5 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 16, 2026.

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 28, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50925536 ↗
• MalfunctionSep 4, 2026Break

  Patient problems: Insufficient Information

  MAUDE report 50621963 ↗
• MalfunctionAug 20, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50356991 ↗
• MalfunctionFeb 9, 2026Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE SINGLE PORT MONOPOLAR CAUTERY INSTRUMENT SHOWED A BLUE LIGHT, BUT DURING THE SURGERY, WHEN ATTEMPTING TO USE THE MONOPOLAR, AN ORANGE LIGHT APPEARED ON THE CORD AND INSTRUMENT. THE CUSTOMER UNPLUGGED AND RE-PLUGGED ALL THE CORDS AND REPLACED THEM WITH NEW ONES, BUT IT STILL DID NOT WORK, AND A 'REPLACE INSTRUMENT' ERROR MESSAGE APPEARED. EVEN AFTER REATTACHING THE INSTRUMENT, IT DID NOT FUNCTION, SO THEY REPLACED IT WITH A NEW INSTRUMENT, AFTER WHICH THE ENERGY COULD BE USED NORMALLY. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24288885 ↗
• MalfunctionDec 15, 2025Unintended System Motion; Unintended System Motion

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED RADICAL TONSILLECTOMY SURGICAL PROCEDURE, THE SINGLE PORT MONOPOLAR CAUTERY INSTRUMENT WAS "OUT OF ALIGNMENT" WHILE USING THE ROBOT; IT MOVED THE WRONG WAY. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23811500 ↗
• MalfunctionNov 27, 2025Break; Break

  IT WAS REPORTED THAT AFTER A DA VINCI-ASSISTED PROSTATECTOMY-SIMPLE TRANSVESICAL SURGICAL PROCEDURE, SINGLE PORT (SP) MONOPOLAR CAUTERY INSTRUMENT TIP BROKE OFF AFTER THE PROCEDURE WHEN THE SURGICAL TECH WAS REMOVING THE SPATULA TIP. THE SPATULA TIP WAS THROWN AWAY BY THE TECH. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. INTUITIVE FOLLOWED UP AND OBTAINED ADDITIONAL INFORMATION. THE INSTRUMENT WAS INSPECTED PRIOR TO USE. THE SURGICAL TASK WAS BEING PERFORMED WHEN THE ISSUE OCCURRED WAS THE SURGICAL TECH WAS REMOVING THE SPATULA TIP FROM INSTRUMENT WHEN IT BROKE OFF, SAID SHE DIDN¿T THINK TO SAVE THE SPATULA TIP FOR ANALYSIS AND THREW IT AWAY. THE CONTACT PERSON DID NOT BELIEVE THE INSTRUMENT DID NOT COLLIDE WITH ANY OTHER INSTRUMENT. THE INCIDENT DID NOT INVOLVE A FRAGMENT FALLING INSIDE THE PATIENT. THERE WERE NO TESTS LIKE AN X-RAY OR ULTRASOUND PERFORMED TO CHECK FOR REMAINING FRAGMENTS. THE PATIENT HAS NOT RETURNED TO THE HOSPITAL DUE TO THE EXPERIENCING ANY COMPLICATION RELATED TO RETAINING A FOREIGN OBJECT. PATIENT DEMOGRAPHICS WERE NOT PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23663494 ↗
• MalfunctionJul 9, 2025Break; Break

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED RADICAL TONSILLECTOMY SURGICAL PROCEDURE, THE SINGLE PORT (SP) MONOPOLAR CAUTERY INSTRUMENT HAD A SPLIT AT THE TIP. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY.

  Patient problems: Insufficient Information

  MAUDE report 22463121 ↗