EndoWrist SP 430010Recalls & reported problems

Summary

The FDA's MAUDE database contains 100 adverse event reports that list this exact device (DI 00886874114322), received between Sep 13, 2022 and Sep 28, 2026 — classified as 15 injuries, 85 malfunctions.

The most frequently reported specific device problem is “Break” (26 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 100 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 50925354 ↗
• MalfunctionAug 12, 2026Unintended Movement

  Patient problems: Insufficient Information

  MAUDE report 50217205 ↗
• MalfunctionMay 22, 2026Break

  IT WAS REPORTED THAT DURING CENTRAL PROCESSING, THE MARYLAND BIPOLAR FORCEPS INSTRUMENT WAS BROKEN AND WAS NOT ALIGNING UP. NO KNOWN IMPACT OR PATIENT CONSEQUENCE WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25262660 ↗
• MalfunctionMay 21, 2026Break

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, USER NOTICED THAT THE LINE AT THE MARYLAND BIPOLAR FORCEPS INSTRUMENT 'S TIP WAS BROKEN. 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 TIP OF THE INSTRUMENT WAS NOT BROKEN OFF OR DETACHED FROM THE SHAFT, AND NO PARTS WERE MISSING. FURTHERMORE, NO FRAGMENT FELL INTO THE PATIENT DURING THE PROCEDURE, SO RETRIEVAL WAS NOT NECESSARY, AND THERE WAS NO INJURY REPORTED. THE INSTRUMENT DID NOT COLLIDE WITH ANY OTHER INSTRUMENTS OR HARD MATERIAL, MINIMIZING THE RISK OF PROCEDURAL COMPLICATIONS. ADDITIONALLY, THERE WERE NO PHOTOGRAPHIC IMAGES OR VIDEO RECORDINGS AVAILABLE FOR ISI REVIEW IN THIS CASE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25248986 ↗
• MalfunctionMay 14, 2026Break

  IT WAS REPORTED THAT DURING CENTRAL PROCESSING, THE SP MARYLAND BIPOLAR FORCEPS INSTRUMENT WAS FOUND TO HAVE A PIECE MISSING FROM THE BACK OF THE ARM. THERE WAS NO REPORT OF FRAGMENT FALLING INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITH NO REPORT OF PATIENT INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER; HOWEVER, THE REPORTER WAS NOT ABLE TO PROVIDE FURTHER DETAILS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25178226 ↗
• MalfunctionApr 14, 2026Break

  IT WAS REPORTED THAT PRIOR TO THE START OF A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE TIP BROKE AT THE JAW OF THE SINGLE PORT MARYLAND BIPOLAR FORCEPS INSTRUMENT. THERE WAS NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE DAMAGE OCCURRED OUTSIDE OF THE SURGICAL PROCEDURE. THERE WAS NO REPORT OF FRAGMENTS FALLING FROM THE DEVICE WHILE USED WITHIN THE PATIENT. THE PATIENT HAS NOT RETURNED TO THE HOSPITAL DUE TO EXPERIENCING ANY POST-SURGICAL COMPLICATIONS. THERE WAS NO MATERIAL MISSING OR DETACHED FROM THE INSTRUMENT.

  Patient problems: Insufficient Information

  MAUDE report 24868201 ↗
• MalfunctionMar 31, 2026Break

  IT WAS REPORTED THAT DURING CENTRAL PROCESSING, THE MARYLAND BIPOLAR FORCEPS INSTRUMENT'S PLASTIC TIP WAS DAMAGED. THERE WAS NO REPORT OF PATIENT INVOLVEMENT OR PATIENT INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER; HOWEVER, THE CUSTOMER WAS UNABLE TO PROVIDE ADDITIONAL INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24748642 ↗
• MalfunctionMar 9, 2026Unintended System Motion

  REFER TO H11 FOR FOLLOW-UP INFORMATION.

  Patient problems: Insufficient Information

  MAUDE report 24547453 ↗
• MalfunctionFeb 23, 2026No Apparent Adverse Event

  REFER TO H11 FOR FOLLOW-UP INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24423393 ↗
• MalfunctionFeb 19, 2026Break

  REFER TO H11 FOR FOLLOW-UP INFORMATION.

  Patient problems: Insufficient Information

  MAUDE report 24395320 ↗
• MalfunctionDec 18, 2025Unintended Movement; Unintended Movement

  REFER TO H11 FOR FOLLOW-UP INFORMATION.

  Patient problems: Insufficient Information

  MAUDE report 23846114 ↗
• MalfunctionDec 16, 2025Unintended System Motion; Unintended System Motion

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE 6MM MARYLAND BIPOLAR FORCEPS INSTRUMENT DID NOT WORK AS EXPECTED. 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 CONDUCTOR WIRE OF INSTRUMENT WAS NOT DAMAGED ON THE WRIST. NO OTHER PHYSICAL DAMAGE WAS OBSERVED. NO MATERIAL WAS MISSING OR DETACHED FROM THE PORTION OF THE DEVICE THAT ENTERS THE PATIENT¿S BODY. THERE WAS NO ALLEGATION OF AN UNCLAMPING FAILURE WHILE THE INSTRUMENT WAS GRIPPING TISSUE. THE INSTRUMENT DID NOT MOVE/FUNCTION AS INTENDED. THE INSTRUMENT WAS NOT MOVING INTUITIVELY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23822326 ↗
• MalfunctionDec 15, 2025Break; Break

  REFER TO H11 FOR FOLLOW-UP INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23811340 ↗
• MalfunctionDec 9, 2025Break; Break

  IT WAS REPORTED THAT DURING CENTRAL PROCESSING, SINGLE-PORT (SP) MARYLAND BIPOLAR FORCEPS (MBF) INSTRUMENT TIP WAS FOUND CHIPPED/BROKEN. THERE WAS NO REPORT OF PATIENT INVOLVEMENT. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE ROBOTIC COORDINATOR (ROCO) AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE SCRUB TECH NOTICED THE TIP DAMAGE BEFORE THE INSTRUMENT WAS USED ON THE PATIENT. NO ARCING OCCURRED. THERE WERE NO PATIENT INJURIES.

  Patient problems: Insufficient Information

  MAUDE report 23753629 ↗
• MalfunctionDec 3, 2025Break; Break

  IT WAS REPORTED THAT DURING CENTRAL PROCESSING , THE JAWS OF 6MM MARYLAND BIPOLAR FORCEPS INSTRUMENT BROKE. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT OR PATIENT INJURY.

  Patient problems: Insufficient Information

  MAUDE report 23701743 ↗
• MalfunctionNov 5, 2025Unintended System Motion; Unintended System Motion

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE SURGEON COULD NOT CONTROL THE MOVEMENT OF THE SINGLE PORT MARYLAND BIPOLAR FORCEPS INSTRUMENT. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23482348 ↗
• MalfunctionOct 23, 2025Unintended System Motion; Unintended System Motion

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED MALIGNANT TONGUE BASE RESECTION SURGICAL PROCEDURE, THE MARYLAND BIPOLAR FORCEPS (MBF) INSTRUMENT MOVED IN THE OPPOSITE DIRECTION. THE PROCEDURE WAS COMPLETED WITH A BACKUP INSTRUMENT, WITH NO REPORTS OF PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23372664 ↗
• MalfunctionOct 20, 2025Break; Break

  IT WAS REPORTED THAT THE MARYLAND BIPOLAR FORCEPS INSTRUMENT WAS TAGGED AND THE PLASTIC AROUND THE DISTAL TIP WAS BROKEN. THE PROCEDURE OUTCOME IS UNKNOWN AT THE TIME OF THE REPORT. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED ADDITIONAL INFORMATION: UPON REVIEW OF THE PROVIDED RESPONSES, THE REPORTER CONFIRMED THAT THE TIP WAS NOT BROKEN OFF OR DETACHED FROM THE TUBE ADAPTER, AND THERE WAS NO DAMAGE OR MISSING PART OBSERVED ON THE ADAPTER. ADDITIONALLY, NO SCRATCH MARKS OR ABRASIONS WERE NOTED. THE LAST USE OF THE INSTRUMENT WAS DURING A PARTIAL NEPHRECTOMY PROCEDURE ON (B)(6), 2025, ON SYSTEM SP0262, BUT IT IS UNKNOWN WHETHER ANY FRAGMENTS FELL INTO THE PATIENT OR IF POST-OPERATIVE IMAGING WAS CONDUCTED TO CHECK FOR REMAINING FRAGMENTS. THE ISSUE WAS IDENTIFIED BY THE SPD TECHNICIAN AFTER THE PROCEDURE, AND THERE WAS NO REPORT OF PATIENT INJURY. THE REPORTER FURTHER INDICATED THAT HOW THE PROCEDURE WAS COMPLETED AND WHETHER THE INSTRUMENT COLLIDED WITH OTHER INSTRUMENTS OR HARD MATERIALS DURING SURGERY IS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23343120 ↗
• InjuryOct 15, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, MARYLAND BIPOLAR FORCEPS AND CADIERE TIP GOT STUCK AND THE TIP BENT AND BROKE DURING SEPARATION. A FRAGMENT WAS RETRIEVED DURING THE SAME PROCEDURE. THE 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 NOTED. THE CUSTOMER WAS RETURNING THE INSTRUMENT TO THE DRIVE CENTER IN ORDER TO UNDOCK WHEN THE FRAGMENT FELL. THE SURGEON DIDN'T NOTICE ANY ISSUES WITH THE FUNCTIONALITY OF THE INSTRUMENT DURING THE SURGICAL PROCEDURE PRIOR TO THE ISSUE. THE FRAGMENT FELL INSIDE OF THE PATIENT DURING AN INSTRUMENT TIP OR ACCESSORY COLLISION. UPON FINAL REMOVAL OF THE INSTRUMENT THE WRIST WAS STRAIGHTENED. THE STAFF NOTICED DIFFICULTY REMOVING THE INSTRUMENTS BECAUSE THE TIP OF THE MARYLAND WAS CAUGHT IN THE HOLE OF THE CADIERE. THE SURGICAL STAFF DIDN'T NOTICE ANY DAMAGE TO THE CANNULA. THE FRAGMENTS WERE REMOVED WITH THE INSTRUMENTS WHILE CHECKING THE ABDOMINAL CAVITY WITH THE CAMERA. THE FRAGMENTS THEN WERE MATCHED TO THE DAMAGED AREA. NO ADDITIONAL SURGICAL PROCEDURE WAS REQ

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23301961 ↗
• MalfunctionSep 16, 2025Break; Break

  IT WAS REPORTED THAT AFTER A DA VINCI-ASSISTED RADICAL PROSTATECTOMY SURGICAL PROCEDURE, THE SHEATHS WERE REMOVED FROM ALL THE INSTRUMENTS, AND THE FRONT PART OF THE INSTRUMENTS FELT LOOSE. UPON INSPECTION, IT APPEARED THAT THE FLEXIBLE PART WAS SEPARATED. 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 INSTRUMENT/ACCESSORY WAS INSPECTED PRIOR TO USE AND WAS FOUND TO BE IN GOOD CONDITION, WITH NO DAMAGE OR ANYTHING OUT OF THE ORDINARY. DURING THE SURGICAL PROCEDURE, THE SURGEON DID NOT NOTICE ANY ISSUES WITH THE INSTRUMENT'S FUNCTIONALITY, AND THERE WERE NO COLLISIONS WITH OTHER INSTRUMENTS OR HARD MATERIALS. CONSEQUENTLY, NO FRAGMENTS FELL INSIDE THE PATIENT, AND NO POST-OPERATIVE TESTS SUCH AS X-RAYS OR ULTRASOUNDS WERE PERFORMED TO CHECK FOR REMAINING FRAGMENTS. THE PROCEDURE WAS COMPLETED ROBOTICALLY WITHOUT ANY INJURY TO THE PATIENT. FURTHERMORE, THE PATIENT HAS NOT RETURNED TO THE HOSPITAL DUE TO ANY POST-SURGICAL COMPLICATIONS RELATED TO RETAINING A FOREIGN OBJECT. PATIENT DEMOGRAPHIC INFORMATION AND RELEVANT MEDICAL HISTORY ARE UNAVAILABLE, AS THE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23068562 ↗
• MalfunctionAug 21, 2025Unintended System Motion; Unintended System Motion

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE CUSTOMER EXPERIENCED REVERSE MOVEMENT ON THE PATIENT SIDE MANIPULATORS (PSM) AND WITH SINGLE-PORT (SP) MARYLAND BIPOLAR FORCEPS (MBF) INSTRUMENT. THE ISSUE ALWAYS STARTED AT THE BEGINNING OF THE PROCEDURE, AND IT WAS NOT DUE TO A CAMERA ISSUE. THE CUSTOMER REPLACED THE INSTRUMENT TO RESOLVE THE ISSUE. THE CUSTOMER STATED THAT THEY WERE IN THE PROCESS OF RESEATING THE ENDOSCOPE AND MAY EXCHANGE IT. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY.

  Patient problems: Insufficient Information

  MAUDE report 22867701 ↗
• MalfunctionAug 18, 2025No Apparent Adverse Event; No Apparent Adverse Event

  IT WAS REPORTED THAT PRIOR TO STARTING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE MARYLAND BIPOLAR FORCEPS INSTRUMENT WAS DAMAGED AT THE TIP. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22834835 ↗
• MalfunctionAug 18, 2025No Apparent Adverse Event; No Apparent Adverse Event

  IT WAS REPORTED THAT DURING CENTRAL PROCESSING, THE MARYLAND BIPOLAR FORCEPS INSTRUMENT HAD A SMALL INJURY TO THE JAW. THERE WAS NO REPORT OF PATIENT INVOLVEMENT OR PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22825186 ↗
• MalfunctionAug 15, 2025No Device Output; No Device Output

  REFER TO H11 FOR FOLLOW-UP INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22820777 ↗
• InjuryAug 13, 2025Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT DURING A SINGLE PORT DA VINCI-ASSISTED CHOLECYSTECTOMY PROCEDURE, THE MARYLAND BIPOLAR FORCEPS INSTRUMENT COLLIDED WITH ANOTHER INSTRUMENT AND BECAME DAMAGED. A FRAGMENT FELL INTO THE PATIENT AND WAS RETRIEVED WITH FORCEPS DURING THE SAME PROCEDURE. THE CUSTOMER CONFIRMED WITH THE SCOPE THAT ALL FRAGMENTS WERE RETRIEVED. NO ADDITIONAL SURGICAL PROCEDURE WAS REQUIRED. THE CUSTOMER DID NOT PERFORM AN X-RAY. THE PROCEDURE WAS COMPLETED ROBOTICALLY USING A BACKUP MARYLAND BIPOLAR FORCEPS INSTRUMENT WITH A DELAY OF LESS THAN 15 MINUTES. THE PATIENT HAS NOT RETURNED TO THE HOSPITAL DUE TO ANY POST-SURGICAL COMPLICATIONS RELATED TO RETAINING A FOREIGN OBJECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22793614 ↗