EndoWrist SP 431100Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 00886874124048), received between Jul 9, 2025 and Sep 29, 2026 — classified as 4 injuries, 13 malfunctions.

The most frequently reported specific device problem is “Break” (8 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 18, 2026.

Most reported problems

Recent adverse event reports

The 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 29, 2026Unintended Movement

  It was reported that prior to starting a da Vinci-assisted Urology surgical procedure, a Monopolar Curved Scissors (MCS) instrument exhibited non intuitive motion. The customer continued with the procedure as planned, and no patient impact or consequence was reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50927526 ↗
• MalfunctionMay 19, 2026Break

  IT WAS REPORTED THAT PRIOR TO A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE TIP OF THE MONOPOLAR CURVED SCISSORS INSTRUMENT COULD NOT BE ATTACHED. THERE WAS NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25224267 ↗
• MalfunctionApr 29, 2026Break

  IT WAS REPORTED THAT THE SINGLE PORT (SP) EXTENDED RANGE MONOPOLAR CURVED SCISSORS HAD A BROKEN TIP. THERE WAS NO REPORT OF PATIENT INVOLVEMENT OR REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) MADE A FOLLOW-UP ATTEMPT TO OBTAIN ADDITIONAL INFORMATION. HOWEVER, NO FURTHER DETAILS COULD BE PROVIDED AND OBTAINED THE FOLLOWING: THE CUSTOMER REPORTED THAT THEY DID NOT HAVE ANY MORE INFORMATION, OTHER THAN WHAT WAS ORIGINALLY OFFERED.

  Patient problems: Insufficient Information

  MAUDE report 25037250 ↗
• MalfunctionApr 22, 2026Break

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED MYOMECTOMY SURGICAL PROCEDURE, THE MONOPOLAR CURVED SCISSORS INSTRUMENT'S EXTENDED R HAD A BREAKAGE RESULTING IN THE SCISSORS TAB DETACHING FROM THE INSTRUMENT. 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 PART OF THE MONOPOLAR CURVED SCISSORS (MCS) EXTENDED R BROKE WAS THE DISTAL END OF SP MONOPOLAR INSTRUMENT. THE INCIDENT DID NOT HAVE A FRAGMENT FALL INSIDE THE PATIENT'S ANATOMY. THE PROCEDURE THE INSTRUMENT WAS USED IN WAS OVARIAN CYSTECTOMY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24959494 ↗
• InjuryMar 30, 2026Material Fragmentation

  REFER TO H11 FOR FOLLOW-UP INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24723125 ↗
• InjuryFeb 25, 2026Detachment of Device or Device Component

  REFER TO H11 FOR FOLLOW-UP INFORMATION.

  Patient problems: Foreign Body In Patient

  MAUDE report 24442310 ↗
• MalfunctionFeb 24, 2026Difficult to Open or Close; Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED MYOMECTOMY SURGICAL PROCEDURE, WHILE EXCISING THE MYOMA PROTRUDING FROM THE FRONT OF THE UTERUS AND DISSECTING THE TISSUE, IT APPEARED ON THE SURGICAL SCREEN THAT THE JAW OF THE MONOPOLAR CURVED SCISSORS (MCS) INSTRUMENT WAS NOT CLOSING COMPLETELY. THE SURGEON ATTEMPTED TO OPEN AND CLOSE THE JAW SEVERAL TIMES AND, SUSPECTING IT WAS NOT FUNCTIONING PROPERLY, REQUESTED AN INSTRUMENT CHECK. UPON REMOVING THE SHEATH AND INSPECTING THE WIRE, IT WAS DISCOVERED THAT THE WIRE NEAR THE TIP WAS BROKEN. WHILE CHECKING THE INSTRUMENT'S OPERATION BY OPENING AND CLOSING THE RELEASE DIAL, IT WAS CONFIRMED THAT THE WIRE WAS BREAKING LITTLE BY LITTLE WHEN THE JAW WAS OPENED AND CLOSED. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24434734 ↗
• MalfunctionFeb 9, 2026Break

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE TIP OF A SINGLE PORT MONOPOLAR CURVED SCISSORS INSTRUMENT HAD A BROKEN TIP. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) CONTACTED THE CUSTOMER BUT WAS NOT ABLE TO OBTAIN ANY ADDITIONAL INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24288877 ↗
• MalfunctionJan 29, 2026No Apparent Adverse Event

  IT WAS REPORTED THAT THE CUSTOMER EXPERIENCED AN ISSUE WITH THE SINGLE PORT (SP) MONOPOLAR CURVED SCISSORS (MCS). THE CUSTOMER REPORTED EVENT HAS NO REPORT OF 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 24217017 ↗
• MalfunctionJan 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 24050514 ↗
• InjuryJan 12, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED HYSTERECTOMY PROCEDURE, THE TIP OF THE MONOPOLAR CURVED SCISSORS (MCS) INSTRUMENT FELL OFF INSIDE THE PATIENT. THE TIP WAS RETRIEVED DURING THE SAME SURGICAL PROCEDURE WHICH WAS COMPLETED ROBOTICALLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24038076 ↗
• InjuryJan 7, 2026Detachment of Device or Device Component

  REFER TO H11 FOR FOLLOW-UP INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23989800 ↗
• MalfunctionDec 16, 2025Break; Break

  IT WAS REPORTED THAT PRIOR TO STARTING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE MONOPOLAR CURVED SCISSORS (MCS) INSTRUMENT'S TIP WAS CHIPPED. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23823893 ↗
• MalfunctionDec 16, 2025Unintended Movement; Unintended Movement

  REFER TO H11 FOR FOLLOW-UP INFORMATION.

  Patient problems: Insufficient Information

  MAUDE report 23813396 ↗
• MalfunctionNov 26, 2025Break; Break

  REFER TO H11 FOR FOLLOW-UP INFORMATION.

  Patient problems: Insufficient Information

  MAUDE report 23653852 ↗
• MalfunctionNov 24, 2025Break; Break

  IT WAS REPORTED THAT PRIOR TO THE START OF A DA VINCI-ASSISTED NEPHRECTOMY SURGICAL PROCEDURE, THE MONOPOLAR CURVED SCISSORS INSTRUMENT'S TIP WAS BROKEN, AND THE SCISSOR COULD NOT BE PLACED. 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 TIP WAS NOTICED BEFORE THE CASE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23639269 ↗
• MalfunctionJul 9, 2025Break; Break

  IT WAS REPORTED THAT DURING CENTRAL PROCESSING, SINGLE-PORT (SP) MONOPOLAR CURVED SCISSORS (MCS) DISTAL TIP WAS FOUND BROKEN. THERE WAS NO REPORT OF PATIENT INVOLVEMENT.

  Patient problems: Insufficient Information

  MAUDE report 22463706 ↗