EndoWrist SP 430004Recalls & reported problems

Summary

The FDA's MAUDE database contains 356 adverse event reports that list this exact device (DI 00886874114285), received between Aug 4, 2021 and Sep 28, 2026 — classified as 36 injuries, 320 malfunctions.

The most frequently reported specific device problem is “Break” (150 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 25 most recent of 356 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 28, 2026Break

  Patient problems: Insufficient Information

  MAUDE report 50926015 ↗
• MalfunctionAug 17, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50288326 ↗
• MalfunctionAug 11, 2026Break

  It was reported that prior to the start of a da Vinci-assisted surgical procedure, a Single Port Monopolar Curved Scissors (MCS) instrument had a missing internal pin. The procedure was completed with no reported injury.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50207792 ↗
• MalfunctionMay 27, 2026Break

  IT WAS REPORTED THAT THE CUSTOMER EXPERIENCED AN ISSUE WITH THE 6MM MONOPOLAR CURVED SCISSORS INSTRUMENT. THE CUSTOMER REPORTED EVENT HAS NO REPORT OF PATIENT INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE CUSTOMER CONFIRMED THAT THE MISSING MATERIAL/DAMAGE WAS IDENTIFIED DURING REPROCESSING AND DID NOT OCCUR WHILE THE DEVICE WAS IN USE WITHIN A PATIENT. THERE WERE NO REPORTS OF FRAGMENTS FALLING FROM THE DEVICE DURING PATIENT USE. NO POST-SURGICAL COMPLICATIONS OR HOSPITAL RETURNS RELATED TO RETAINED FOREIGN MATERIAL WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25308461 ↗
• MalfunctionMay 27, 2026No Apparent Adverse Event

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25308087 ↗
• MalfunctionMay 27, 2026Break

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE MONOPOLAR CURVED SCISSORS INSTRUMENT WAS NOT WORKING. THERE WAS NO REPORTED INJURY. 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 25307716 ↗
• MalfunctionMay 22, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING CENTRAL PROCESSING, THE SINGLE PORT MONOPOLAR CURVED SCISSORS INSTRUMENT WAS DAMAGED AT THE PLASTIC IN THE JAW. THERE WAS NO REPORT OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25257923 ↗
• MalfunctionMay 19, 2026Break; Use of Device Problem

  IT WAS REPORTED THAT PRIOR TO THE START OF A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE CUSTOMER WAS UNABLE TO INSTALL THE SCISSORS TIP TO THE SINGLE PORT (SP) MONOPOLAR CURVED SCISSORS INSTRUMENT. THE SAME TIP WAS ABLE TO BE INSTALLED ON A DIFFERENT INSTRUMENT. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. ISI FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE DAMAGED INSTRUMENT WAS PASSED OFF OF THE FIELD BEFORE THE SURGERY STARTED. BECAUSE THE TECH WAS UNABLE TO INSTALL THE SCISSOR TIP IMMEDIATELY AFTER IT WAS OPENED TO THE FIELD, SITE ASSUME THE DAMAGE OCCURRED OUTSIDE OF A SURGICAL PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25224046 ↗
• MalfunctionMay 18, 2026Arcing

  IT WAS REPORTED THAT DURING CENTRAL PROCESSING, THE MONOPOLAR CURVED SCISSOR INSTRUMENT WAS NOTED TO HAVE PART OF THE SHEATH REMAINING. THERE WAS NO REPORT OF PATIENT INVOLVEMENT OR PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25210567 ↗
• MalfunctionMay 15, 2026No Apparent Adverse Event

  IT WAS REPORTED THAT THE CUSTOMER EXPERIENCED AN ISSUE WITH THE MONOPOLAR CURVED SCISSORS. THE CUSTOMER REPORTED EVENT HAS NO REPORT OF PATIENT INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE DAMAGE TO THE DEVICE OCCURRED OUTSIDE OF A SURGICAL PROCEDURE AND NOT WHILE IN USE WITHIN THE PATIENT. THERE WERE NO REPORTS OF FRAGMENTS FALLING FROM THE DEVICE, AND NO MATERIAL WAS MISSING OR DETACHED FROM THE INSTRUMENT. THE TIP ACCESSORY WAS ABLE TO BE INSTALLED SECURELY AND DID NOT FALL ONCE IN PLACE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25179994 ↗
• MalfunctionMay 14, 2026Material Integrity Problem

  IT WAS REPORTED THAT THE 6MM SINGLE PORT (SP) MONOPOLAR CURVED SCISSORS (MCS) INSTRUMENT HAD A DAMAGED HOUSING. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 25177571 ↗
• MalfunctionMay 13, 2026Unintended Movement

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE MONOPOLAR CURVED SCISSORS INSTRUMENT WAS NOT RESPONDING PROPERLY NOR CUTTING PROPERLY. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25164462 ↗
• MalfunctionMay 9, 2026No Apparent Adverse Event

  IT WAS REPORTED THAT DURING CENTRAL PROCESSING, 6MM MONOPOLAR CURVED SCISSORS INSTRUMENT WAS FOUND TO BE BROKEN. THERE WAS NO REPORT OF PATIENT INVOLVEMENT OR PATIENT INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE INSTRUMENT WAS DESCRIBED AS BROKEN; HOWEVER, THE FAILURE WAS NOT RELATED TO THE MOVEMENT OF THE INSTRUMENT DURING USE. UPON INSPECTION, NO PHYSICAL DAMAGE WAS NOTED, AND THERE WAS NO MATERIAL DETACHED FROM THE INSTRUMENT. FURTHERMORE, THERE WAS NO EVIDENCE OF A BROKEN CABLE AT THE DISTAL END, NOR WERE THERE ANY SIGNS OF THERMAL DAMAGE. ALL COMPONENTS APPEARED INTACT, AND NO FRAGMENTS WERE LOST AS A RESULT OF THE FAILURE. ALTHOUGH THE INSTRUMENT WAS REPORTED AS BROKEN, THERE WERE NO VISIBLE SIGNS OF MECHANICAL, ELECTRICAL, OR THERMAL DAMAGE, AND NO DETACHMENT OF MATERIAL WAS OBSERVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25131908 ↗
• MalfunctionMay 6, 2026Material Fragmentation

  IT WAS REPORTED THAT THE CUSTOMER EXPERIENCED AN ISSUE WITH THE MONOPOLAR CURVED SCISSORS. THE CUSTOMER REPORTED EVENT HAS NO REPORT OF PATIENT INJURY. INTUITIVE FOLLOWED UP BUT NO ADDITIONAL INFORMATION WAS AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 25090242 ↗
• MalfunctionMay 1, 2026Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT DURING CENTRAL PROCESSING, THE PLASTIC WAS CRACKED/MISSING AT TIP. THERE WAS NO REPORT OF PATIENT INVOLVEMENT.

  Patient problems: Insufficient Information

  MAUDE report 25062175 ↗
• MalfunctionApr 29, 2026Unintended Movement

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, SINGLE PORT (SP) MONOPOLAR CURVED SCISSORS (MCS) INSTRUMENT HAD OPENING/CLOSING MALFUNCTION. A BACK-UP INSTRUMENT WAS USED TO RESOLVE THE REPORTED ISSUE. THE PROCEDURE WAS COMPLETING AS PLANNED WITH NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25037185 ↗
• MalfunctionApr 23, 2026Unintended System Motion

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE MONOPOLAR CURVED SCISSORS INSTRUMENT WAS NOT RESPONDING. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. ISI FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION ON 30-MAR-2026: THE JAWS OF THE INSTRUMENT REMAINED COMPLETELY STATIC WHILE IN THE OPEN POSITION, AND NO BROKEN CABLE WAS VISIBLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24973132 ↗
• MalfunctionApr 23, 2026Break

  IT WAS REPORTED THAT AFTER A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE SP MONOPOLAR CURVED SCISSORS INSTRUMENT HAD BROKEN COILS THAT WERE PROTRUDING FROM THE TOP OF THE INSTRUMENT. THERE WAS NO REPORT OF PATIENT INVOLVEMENT. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: NO FRAGMENT OF THE INSTRUMENT FELL INSIDE THE PATIENT¿S ANATOMY DURING THE PROCEDURE, AND THERE WAS NO INCIDENT OF AN INSTRUMENT PART BREAKING OFF OR DETACHING WHILE IN USE. THE PATIENT DID NOT SUFFER ANY INJURY RELATED TO THIS EVENT. THE ISSUE WAS ONLY IDENTIFIED AFTER THE PROCEDURE HAD BEEN COMPLETED AND THE INSTRUMENT HAD BEEN PROCESSED THROUGH THE STERILIZER. NO PHOTOGRAPHIC IMAGES OR VIDEO RECORDINGS OF THE DEVICE OR THE PROCEDURE ARE AVAILABLE FOR REVIEW BY INTUITIVE SURGICAL, INC. (ISI).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24961871 ↗
• InjuryApr 22, 2026Material Fragmentation; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED MALIGNANT MASTECTOMY SURGICAL PROCEDURE, THE MONOPOLAR CURVED SCISSOR (MCS) TIP DETACHED FROM THE MCS INSTRUMENT AND FELL INSIDE THE PATIENT. AFTER RETRIEVING THE MCS TIP, IT WAS DISCOVERED THAT A PIECE OF PLASTIC ABOUT 1 MM IN SIZE WAS MISSING FROM THE END OF THE INSTRUMENT WHERE THE MCS TIP CONNECTS. A POST-OPERATIVE X-RAY WAS PERFORMED; HOWEVER, THE RESULTS ARE UNKNOWN. THE PROCEDURE WAS COMPLETED. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE MCS INSTRUMENT WAS INSPECTED PRIOR TO USE, WITH NO VISIBLE DAMAGE OR ABNORMALITIES NOTED. DURING THE SURGICAL PROCEDURE, A DEVICE FRAGMENT FELL INSIDE THE PATIENT WHILE THE INSTRUMENT WAS BEING USED FOR DISSECTING AND RETRACTING TISSUE AFTER APPROXIMATELY 30 MINUTES OF USE. THE SURGEON DID NOT OBSERVE ANY FUNCTIONALITY ISSUES, AND THERE WAS NO COLLISION BETWEEN INSTRUMENTS OR WITH HARD MATERIALS. THE FRAGMENT WAS NOT RETRIEVED. NO ADDITIONAL SURGICAL PROCEDURE WAS PERFORMED TO ATTEMPT RETRIEVAL OF THE MISSING FRAGMENT. THE SURGERY WAS COMPLETED ROBOTICALLY WITHOUT PATIENT INJURY, AND THERE HAVE BEEN NO REPORTED POST

  Patient problems: Foreign Body In Patient

  MAUDE report 24955386 ↗
• MalfunctionApr 21, 2026Break

  IT WAS REPORTED THAT PRIOR TO START OF DA VINCI-ASSISTED SURGICAL PROCEDURE; WHILE PLACING TIP COVER ON MONOPOLAR CURVED SCISSORS, GREY PART OF TIP FELL OFF. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24934400 ↗
• MalfunctionApr 17, 2026No Apparent Adverse Event

  REFER TO H11 FOR FOLLOW-UP INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24912782 ↗
• MalfunctionApr 13, 2026Break

  IT WAS REPORTED THAT PRIOR TO A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE TIP OF THE SINGLE PORT (SP) MONOPOLAR CURVED SCISSORS (MCS) INSTRUMENT WAS BROKEN. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC.(ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: Insufficient Information

  MAUDE report 24866581 ↗
• MalfunctionApr 10, 2026Break

  IT WAS REPORTED THAT DURING DA VINCI-ASSISTED SURGICAL PROCEDURE, THE TIP OF MONOPOLAR CURVED SCISSORS WAS FOUND TO BE BROKEN. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24838111 ↗
• MalfunctionApr 7, 2026Break

  IT WAS REPORTED THAT PRIOR TO STARTING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE MONOPOLAR CURVED SCISSORS INSTRUMENT RETAINING CLIP AT THE INSTRUMENT TIP WAS BROKEN. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY.

  Patient problems: Insufficient Information

  MAUDE report 24811630 ↗
• MalfunctionApr 3, 2026Break

  IT WAS REPORTED THAT THE MONOPOLAR CURVED SCISSORS INSTRUMENT WAS BROKEN. THE CUSTOMER REPORTED EVENT HAS NO REPORT OF PATIENT INJURY.

  Patient problems: Insufficient Information

  MAUDE report 24783492 ↗