EndoWrist SP 430100Recalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 00886874123454), received between Oct 15, 2025 and Sep 28, 2026 — classified as 2 injuries, 17 malfunctions.

The most frequently reported specific device problem is “Break” (9 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 19 most recent of 19 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 28, 2026Break

  It was reported that during central processing, the user reported that the tip of a Single Port Monopolar Curved Scissors instrument was broken. There was no report of patient involvement or patient injury.

  Patient problems: Insufficient Information

  MAUDE report 50910834 ↗
• MalfunctionSep 25, 2026Unintended Movement

  It was reported that during a da Vinci-assisted surgical procedure, the joint was not bending properly and kept moving differently from the console input. Customer tried detaching it to reassemble the sheath, and replaced it with a new one, but the same issue persisted. After switching to a different Monopolar Curved Scissors arm, it functioned correctly.The procedure was completed with no reported injury.

  Patient problems: Insufficient Information

  MAUDE report 50895164 ↗
• MalfunctionAug 13, 2026Break

  It was reported that during central processing, a Single Port Monopolar Curved Scissors instrument had broken tip. There was no report of patient involvement.Intuitive Surgical, Inc. (ISI) contacted the customer and obtained the following information: The instrument was not used on the patient in the procedure, so no fragments fell into the patient.

  Patient problems: Insufficient Information

  MAUDE report 50231275 ↗
• MalfunctionMay 27, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED RECONSTRUCTIVE SURGICAL PROCEDURE, THE TIP OF MONOPOLAR CURVED SCISSORS INSTRUMENT WAS LOCKED IN PLACE BUT WOBBLY. IT WAS NOT RIGHT ENOUGH TO CUT CORRECTLY. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25309704 ↗
• MalfunctionMay 18, 2026Unintended System Motion

  IT WAS REPORTED THAT PRIOR TO THE START OF A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE 6MM MONOPOLAR CURVED SCISSORS INSTRUMENT WAS MOVING IN THE OPPOSITE DIRECTION THAN INTENDED. 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 ISSUE OCCURRED WHILE THE SURGEON WAS SEATED AT THE SURGEON CONSOLE WITH THEIR HEAD INSIDE THE HIGH RESOLUTION STEREO VIEWER AND ATTEMPTING TO MANIPULATE INSTRUMENTS. WHEN TRYING TO MOVE THE INSTRUMENT LEFT, IT MOVED RIGHT, AND VICE VERSA; THE INSTRUMENT'S MOVEMENT WAS OPPOSITE TO WHAT WAS INTENDED. IT IS UNCLEAR WHETHER THE INSTRUMENT MOVEMENT WAS PROPORTIONAL TO THE SURGEON¿S HAND MOVEMENTS OR IF THERE WAS ANY LAG, BUT NO COMPLAINTS OF DELAY OR SHAKINESS WERE REPORTED. THE ISSUE HAPPENED PERSISTENTLY: AFTER RESEATING THE INSTRUMENT, THE PROBLEM RECURRED, AND THE INSTRUMENT HAD TO BE REPLACED WITH A NEW ONE. THERE WERE NO PATIENT INJURIES, INSTRUMENT OR SYSTEM COLLISIONS, OR UNUSUAL FINDINGS DURING PRE-USE INSPECTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25209032 ↗
• MalfunctionMay 4, 2026Material Split, Cut or Torn

  IT WAS REPORTED THAT PRIOR TO START OF DA VINCI-ASSISTED SURGICAL PROCEDURE, THE MONOPOLAR CURVED SCISSORS INSTRUMENT WAS FOUND TO HAVE PROTRUDING WIRE AND WAS BENT. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. ISI FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE DAMAGE WAS IDENTIFIED PRIOR TO THE START OF THE PROCEDURE DURING PREPARATION. NO FRAGMENTS FELL INTO THE PATIENT, AND ALL OBSERVED DAMAGE OR MATERIAL LOSS OCCURRED OUTSIDE OF SURGERY. ADDITIONALLY, THERE WERE NO INSTANCES OF THE PATIENT RETURNING TO THE HOSPITAL DUE TO COMPLICATIONS ASSOCIATED WITH THE RETENTION OF FOREIGN MATERIAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25074426 ↗
• MalfunctionApr 23, 2026Material Split, Cut or Torn

  IT WAS REPORTED DURING A DA VINCI ASSISTED PARTIAL NEPHRECTOMY SURGICAL PROCEDURE; A SMALL, GRAY PLASTIC PIECE WAS BROKEN ON TIP OF SP MCS INSTRUMENT. THE CUSTOMER REPORTED EVENT HAS NO REPORT OF PATIENT INJURY AS THE DEVICE WAS NOT USED ON PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24971965 ↗
• MalfunctionMar 30, 2026Break

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE SINGLE PORT (SP) MONOPOLAR CURVED SCISSORS INSTRUMENT HAD A CHIP AT THE TIP. THE PROCEDURE WAS COMPLETING AS PLANNED WITH NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24736174 ↗
• InjuryMar 26, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED HYSTERECTOMY SURGICAL PROCEDURE, THE MONOPOLAR CURVED SCISSORS (MCS) TIP CONNECTION BROKE DURING CATHETERIZATION, CAUSING THE TIP TO DETACH AND FALL INTO THE ABDOMINAL CAVITY. ALL VISIBLE PIECES OF THE TIP WERE REMOVED. THE PROCEDURE WAS PERFORMED USING A BACKUP DEVICE, DELAYING THE SURGERY BY APPROXIMATELY 10 MINUTES. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: DURING THE PROCEDURE, THE CONNECTING PART BETWEEN THE TIP AND THE INSTRUMENT BROKE OFF RESULTING IN FRAGMENTS AND THE TIP FALLING INTO THE PATIENT. THESE FRAGMENTS WERE RETRIEVED DURING THE SAME PROCEDURE BY THE ASSISTANT USING A LAPAROSCOPIC INSTRUMENT. THE TEAM VISUALLY CONFIRMED THAT ALL FRAGMENTS WERE REMOVED. NO POST-OPERATIVE IMAGING, SUCH AS X-RAYS OR ULTRASOUNDS, WAS CONDUCTED TO CHECK FOR RESIDUAL FRAGMENTS. THE PATIENT HAS NOT RETURNED WITH ANY POST-SURGICAL COMPLICATIONS RELATED TO A RETAINED FOREIGN OBJECT. THERE WERE NO INJURIES OR COMPLICATIONS AS A RESULT OF THIS INCIDENT, NOR WAS ANY ADDITIONAL SURGICAL PROCEDURE REQUIRED FOR FRAGMENT REMOVAL. WHILE THE INSTRUMENT IS AVAILABLE TO BE RET

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24698383 ↗
• InjuryMar 16, 2026Material Fragmentation; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE MONOPOLAR CURVED SCISSORS (MCS) TIP DETACHED FROM THE MCS INSTRUMENT. WHILE REMOVING THE MCS TIP, THE CUSTOMER NOTICED THAT THE INSTRUMENT'S JOINT WAS BROKEN AND SOME PIECES HAD FALLEN OFF. THE CUSTOMER IMMEDIATELY REMOVED THE FRAGMENTS DURING THE SAME SURGICAL PROCEDURE WHICH WAS COMPLETED ROBOTICALLY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE MCS INSTRUMENT WAS INSPECTED PRIOR TO USE AND SHOWED NO DAMAGE OR ABNORMALITIES. THE FRAGMENT(S) FELL OFF DURING REMOVAL OF THE INSTRUMENT REMOVAL. THERE WAS NO COLLISION WITH OTHER INSTRUMENTS AND NO RESISTANCE WAS FELT DURING REMOVAL OF THE INSTRUMENT. NO DAMAGE WAS OBSERVED TO THE CANNULA. THE FRAGMENT WAS RETRIEVED DURING THE SAME PROCEDURE, WITH CONFIRMATION THAT ALL PIECES WERE ACCOUNTED FOR BY MATCHING THEM WITH THE INSTRUMENT. NO ADDITIONAL SURGICAL PROCEDURES OR POST-OPERATIVE TESTS (SUCH AS X-RAYS OR ULTRASOUNDS) WERE REQUIRED, AND THE PROCEDURE WAS COMPLETED ROBOTICALLY WITHOUT ANY INJURY TO THE PATIENT OR POST-SURGICAL COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24611739 ↗
• MalfunctionMar 10, 2026Break

  IT WAS REPORTED THAT DURING A TRAINING/DEMO OF THE DA VINCI SYSTEM, THE DISPOSABLE MCS TIP COVER OF THE MONOPOLAR CURVED SCISSORS INSTRUMENT WOULD NOT ATTACH; A PIECE BROKE OFF DURING THE ATTEMPTS. THERE WAS NO REPORT OF PATIENT INVOLVEMENT. ISI FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE TIP ACCESSORY WOULD GO ON BUT DID NOT SCREW. ONCE INSTALLED IT WOULD FALL OFF. THERE WAS NO PATIENT INVOLVEMENT AS IT WAS DURING A TRAINING SESSION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24563620 ↗
• MalfunctionFeb 25, 2026Break

  IT WAS REPORTED THAT PRIOR TO START OF DA VINCI-ASSISTED SURGICAL PROCEDURE, THE TIP COVER OF MONOPOLAR CURVED SCISSORS COULD NOT BE REMOVED AND NEW ONE COULD NOT BE ATTACHED. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY

  Patient problems: Insufficient Information

  MAUDE report 24450632 ↗
• MalfunctionFeb 3, 2026Unintended System Motion

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED RETROPERITONEAL ANTERIOR PARTIAL NEPHRECTOMY SURGICAL PROCEDURE, THE CUSTOMER INFORMED INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) THAT THE SINGLE-PORT (SP) MONOPOLAR CURVED SCISSORS (MCS) ORIENTATION WAS 90 DEGREES TO THE INTENDED TURN BY SURGEON¿S HAND. THE TSE COULD NOT FIND ANY RELATED ERROR IN THE LOGS. THE TSE HAD THE CUSTOMER SWAP THE SP MCS ON A DIFFERENT PATIENT SIDE MANIPULATOR (PSM) ARM, AND THE ISSUE PERSISTED ON THE SP MCS INSTRUMENT. THE TSE HAD THE CUSTOMER REPLACED THE SP MCS INSTRUMENT, WHICH RESOLVED THE ISSUE. THE TSE ADVISED THE CUSTOMER TO RETURN THE INSTRUMENT. THE PROCEDURE WAS COMPLETING AS PLANNED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE ROBOTIC COORDINATOR AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE INSTRUMENT WILL NOT BE RETURNED. THE ROCO SUSPECTED THAT THE INSTRUMENT WAS STERILIZED, WRAPPED AND SENT BACK UP BY ACCIDENT. THE ROCO DID NOT ENCOUNTER ANY FURTHER ISSUES WITH THE SCISSORS INSTRUMENT DURING AN OPERATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24248300 ↗
• MalfunctionJan 13, 2026Break

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE TIP OF THE MONOPOLAR CURVED SCISSORS INSTRUMENT WAS CRACKED. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24061751 ↗
• MalfunctionDec 31, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING CENTRAL PROCESSING, THE SINGLE-PORT (SP) MONOPOLAR CURVED SCISSORS (MCS) INSTRUMENT GRAY PART OF THE TIP OF THE INSTRUMENT FOR ATTACHING THE MCS CHIP WAS MISSING. THERE WAS NO REPORT OF PATIENT INVOLVEMENT. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE THERMAL DAMAGE WAS IDENTIFIED IN CENTRAL PROCESSING AFTER CLEANING. THE INSTRUMENT WAS INSPECTED FOR DAMAGE PRIOR TO REPROCESSING AND THERE WAS NO DAMAGE OR ANYTHING OUT TO THE ORDINARY OBSERVED. DURING THE PROCEDURE ON (B)(6) 2025, THE INSTRUMENT WAS INSPECTED PRIOR TO USE. IT WAS OBSERVED THAT IT WAS HARD TO ATTACH THE MONOPOLAR CURVED SCISSORS (MCS) TIP. THE INSTRUMENT WAS ALSO INSPECTED AFTER USE AND NOTHING OUT OF THE ORDINARY WAS OBSERVED. IT WAS UNKNOWN IF THERE WERE ANY INSTRUMENT COLLISIONS. THERE WERE NO REPORTS OF FRAGMENTS FALLING INTO THE PATIENT. THE PATIENT HAS NOT RETURNED DUE TO ANY POST-SURGICAL COMPLICATION RELATED TO RETENTION OF FOREIGN MATERIAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23931943 ↗
• MalfunctionDec 20, 2025Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE THAT THE TIP OF THE MONOPOLAR CURVED SCISSORS (MCS) INSTRUMENT BECAME DETACHED. THE USER REINSTALLED THE MCS TIP AND HAD NO ISSUES USING THE INSTRUMENT. AFTER THE PROCEDURE WAS COMPLETED, THE USER FOUND DAMAGE TO THE TIP. THERE WERE NO REPORTS OF PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23858439 ↗
• MalfunctionDec 15, 2025Break; Material Fragmentation; Break; Material Fragmentation

  REFER TO H11 FOR FOLLOW-UP INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23800058 ↗
• MalfunctionDec 1, 2025Break; Break

  IT WAS REPORTED THAT THE 6MM MONOPOLAR CURVED SCISSORS INSTRUMENT TIP WAS BROKEN.

  Patient problems: Insufficient Information

  MAUDE report 23688258 ↗
• MalfunctionOct 15, 2025Break; Break

  REFER TO H11 FOR FOLLOW-UP INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23305360 ↗