EndoWrist SP 430011Recalls & reported problems

Summary

The FDA's MAUDE database contains 170 adverse event reports that list this exact device (DI 00886874114339), received between May 7, 2022 and Sep 24, 2026 — classified as 55 injuries, 115 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (54 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 25 most recent of 170 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 24, 2026Entrapment of Device

  It was reported that during a da Vinci-assisted surgical procedure, the Single Port (SP) Force Bipolar instrument jammed in the closed position, trapping tissue and making it impossible to open.The procedure was completed with no reported injury.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50886482 ↗
• MalfunctionSep 23, 2026Material Twisted/Bent

  It was reported that during a da Vinci-assisted surgical procedure, Single Port (SP) Fenestrated Bipolar Forceps instrument had misaligned jaws.The procedure was completed with no reported injury.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50864100 ↗
• MalfunctionJun 26, 2026Thermal Decomposition of Device

  IT WAS REPORTED THAT DURING CENTRAL PROCESSING, THE TIPS OF THE SINGLE PORT (SP) FENESTRATED BIPOLAR FORCEPS INSTRUMENT WILL NOT ALIGN. THERE WAS NO REPORT OF PATIENT INVOLVEMENT.

  Patient problems: Insufficient Information

  MAUDE report 25644635 ↗
• MalfunctionMay 27, 2026Break; Material Twisted/Bent

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED PROSTATECTOMY - SIMPLE TRANSVESICAL SURGICAL PROCEDURE, THE FENESTRATED BIPOLAR FORCEPS INSTRUMENT'S DISTAL TIP GOT BROKEN OUTSIDE THE PATIENT'S ANATOMY. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25307406 ↗
• InjuryMay 20, 2026Failure to Deliver Energy; Energy Output Problem

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED BENIGN HYSTERECTOMY PROCEDURE, BLEEDING OCCURRED WHILE PERFORMING TISSUE DISSECTION AND HEMOSTASIS WITH THE FENESTRATED BIPOLAR FORCEPS (FBF) INSTRUMENT. THE SURGEON REPORTED DIMINISHED ENERGY OUTPUT AND REDUCED SMOKE GENERATION DURING THIS EVENT. DESPITE REMOVING THE INSTRUMENT, THOROUGHLY CLEANING THE JAWS, AND PERFORMING ANOTHER COAGULATION ATTEMPT, THE ISSUE PERSISTED. THERE WERE NO COLLISIONS, THERMAL DAMAGE, OR VISIBLE CABLES. THE PATIENT DID NOT REQUIRE A BLOOD TRANSFUSION, AS THE BLEEDING WAS ANTICIPATED AND CONSIDERED MINIMAL. TO RESOLVE THE ISSUE, A BACKUP FBF INSTRUMENT WAS USED, AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE IS NO CONCERN ABOUT THIS EVENT CAUSING ANY LONG-TERM COMPLICATIONS, AND THE PATIENT DID NOT EXPERIENCE ANY POST-OPERATIVE COMPLICATIONS.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 25229726 ↗
• InjuryMay 20, 2026Insufficient Device Problem Information

  IT WAS REPORTED DURING A DA VINCI-ASSISTED NIPPLE SPARING MASTECTOMY PROCEDURE, A 9 MM SKIN BURN WAS NOTICED 2 CM LATERAL TO THE RIGHT NIPPLE. THE PROCEDURE WAS CONTINUED AND COMPLETED AS PLANNED. THE SURGEON REPORTED THAT THE FENESTRATED BIPOLAR FORCEPS (FBF) INSTRUMENT TIP IS NOT FINE, WHICH CREATED DIFFICULTIES SEEING HOW MUCH TISSUE WAS IN THE JAWS WHILE CAUTERIZING DURING THE PROCEDURE. BACITRACIN OINTMENT WAS APPLIED TO THE TWO SMALL SUPERFICIAL WOUNDS AND THE PATIENT WAS ADVISED TO CONTINUE APPLICATION OF VASELINE GAUZE DAILY.

  Patient problems: Burn(s)

  MAUDE report 25229236 ↗
• MalfunctionMay 12, 2026Material Twisted/Bent

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE FENESTRATED BIPOLAR FORCEPS INSTRUMENT TIPS DO NOT ALIGN WELL. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25155509 ↗
• MalfunctionMay 4, 2026Break

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, USER NOTICED THAT THE FENESTRATED BIPOLAR FORCEPS INSTRUMENT HAD A BROKEN TIP. THE USER CONTINUED AND COMPLETED THE PROCEDURE AS PLANNED. 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 MATERIAL WAS DETACHED OR MISSING FROM THE PORTION OF THE DEVICE THAT ENTERS THE PATIENT¿S BODY. HOWEVER, IT WAS STATED THAT THE INCIDENT DID NOT INVOLVE A FRAGMENT FALLING INSIDE PATIENT ANATOMY. THE REPORTER ALSO CONFIRMED THAT THERE WAS NO INJURY TO THE PATIENT AS A RESULT OF THE INCIDENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25074423 ↗
• MalfunctionApr 29, 2026Break; Material Fragmentation

  IT WAS REPORTED THAT AFTER A DA VINCI-ASSISTED SURGICAL PROCEDURE THAT THE PLASTIC PART AT THE BOTTOM OF THE TIP OF THE SINGLE PORT FENESTRATED BIPOLAR FORCEPS INSTRUMENT WAS FOUND TO BE BROKEN. THERE WERE NO REPORTS OF FRAGMENTS FALLING INTO THE PATIENT.

  Patient problems: Insufficient Information

  MAUDE report 25029736 ↗
• MalfunctionApr 21, 2026Material Split, Cut or Torn

  IT WAS REPORTED THAT THE CUSTOMER EXPERIENCED AN ISSUE WITH AN INTUITIVE PRODUCT. THE CUSTOMER REPORTED EVENT HAS NO REPORT OF PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24946730 ↗
• MalfunctionApr 7, 2026No Apparent Adverse Event

  IT WAS REPORTED THAT THE CUSTOMER EXPERIENCED AN ISSUE WITH AN INTUITIVE PRODUCT. THE CUSTOMER REPORTED EVENT HAS NO REPORT OF PATIENT INJURY. ISI FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE ISSUE WITH THE DEVICE OCCURRED DURING SURGERY, BUT NO FRAGMENTS FELL INTO THE PATIENT. THERE WAS NO REPORT OF ANY MISSING OR DETACHED MATERIAL FROM THE INSTRUMENT, AND THE PATIENT HAS NOT RETURNED TO THE HOSPITAL WITH ANY POST-SURGICAL COMPLICATIONS RELATED TO FOREIGN MATERIAL RETENTION.

  Patient problems: Insufficient Information

  MAUDE report 24810316 ↗
• MalfunctionMar 30, 2026Unintended Movement

  IT WAS REPORTED DURING THE DA VINCI ASSISTED SIMPLE EXTRAPERITONEAL PROSTATECTOMY SURGICAL PROCEDURE, THE FENESTRATED BIPOLAR FORCEPS INSTRUMENT WAS MOVING IN THE OPPOSITE DIRECTION AS INTENDED. THE CUSTOMER REMOVED IT FOR ANOTHER INSTRUMENT TO RESOLVE THE ISSUE. THE TECHNICAL SERVICE ENGINEER (TSE) ATTEMPTED TO REVIEW THE LOGS BUT ONSITE WAS NOT AVAILABLE. THE TSE RECOMMENDED RESEATING THE ENDOSCOPE TO TRY AND RESOLVE THE ISSUE. THE PROCEDURE WAS COMPLETING AS PLANNED WITH NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24734964 ↗
• MalfunctionMar 18, 2026Break

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE SINGLE PORT FENESTRATED BIPOLAR FORCEPS INSTRUMENT TIP DID NOT MEET. 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 DAMAGE WAS IDENTIFIED OUTSIDE OF A SURGICAL PROCEDURE, NOT WHILE IN USE WITHIN A PATIENT. THEREFORE, THERE IS NO REPORT OF A FRAGMENT FALLING INTO THE PATIENT'S ANATOMY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24624735 ↗
• MalfunctionMar 16, 2026Unintended System Motion

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED BENIGN HYSTERECTOMY SURGICAL PROCEDURE, THE SINGLE PORT (SP) FENESTRATED BIPOLAR FORCEPS INSTRUMENT DID NOT MOVE PROPERLY AND THE INSTRUMENT MOTION WAS NOT INTUITIVE. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24608252 ↗
• MalfunctionMar 12, 2026Energy Output Problem

  REFER TO H11 FOR FOLLOW-UP INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24584703 ↗
• InjuryMar 9, 2026Material Separation

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, A FRAGMENT FELL OFF FROM THE FENESTRATED BIPOLAR FORCEPS INSTRUMENT. THE FRAGMENT WAS RETRIEVED DURING THE SAME SURGICAL PROCEDURE WHICH WAS COMPLETED AS PLANNED. A POST-OPERATIVE X-RAY WAS ALSO PERFORMED. INTUITIVE SURGICAL, INC. (ISI) HAS ATTEMPTED TO GATHER ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT; HOWEVER, NO RESPONSE HAS BEEN RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24552475 ↗
• MalfunctionFeb 13, 2026Break

  IT WAS REPORTED THAT DURING CENTRAL PROCESSING, THE PLASTIC AT THE DISTAL END OF THE 6MM FENESTRATED BIPOLAR FORCEPS INSTRUMENT WAS CHIPPING. THERE WAS NO REPORT OF PATIENT INVOLVEMENT. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE INSTRUMENT WAS BROKEN DURING CENTRAL PROCESSING. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24330031 ↗
• InjuryJan 27, 2026Material Fragmentation

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED RADICAL EXTRAPERITONEAL PROSTATECTOMY WITHOUT LYMPHADENECTOMY PROCEDURE, THE TIP OF THE FENESTRATED BIPOLAR INSTRUMENT WAS OBSERVED TO BE BROKEN. A FRAGMENT FELL INSIDE THE PATIENT BUT WAS RETRIEVED DURING THE SAME SURGICAL PROCEDURE WHICH WAS COMPLETED ROBOTICALLY. THE INITIAL REPORTER INDICATED THAT THE INSTRUMENT BROKE WHILE THE OR STAFF WAS HOLDING AN ULTRASOUND DEVICE. NO ADDITIONAL SURGICAL PROCEDURE WAS REQUIRED AND NO X-RAYS WERE PERFORMED DUE TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24190297 ↗
• MalfunctionJan 13, 2026Device Dislodged or Dislocated

  REFER TO H11 FOR FOLLOW-UP INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24050519 ↗
• MalfunctionJan 7, 2026Crack; Unintended Movement

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED PARTIAL NEPHRECTOMY SURGICAL PROCEDURE, THE FENESTRATED BIPOLAR FORCEPS INSTRUMENT WOULD NOT COMPLETELY CLOSE WHEN GRASPING TISSUE. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. ISI FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE CUSTOMER CONFIRMED THAT NO ARCING WAS OBSERVED DURING THE PROCEDURE, AND THERE WERE NO RELATED INCIDENTS SUCH AS SPARKING OR SMOKE. NO OTHER INSTRUMENTS WERE IN USE THAT COULD BE ASSOCIATED WITH AN ARCING EVENT, AND THE EVENT DID NOT ORIGINATE FROM ANY INSTRUMENT INVOLVED IN THE COMPLAINT. ADDITIONALLY, THERE WERE NO PATIENT INJURIES OR ADVERSE EVENTS REPORTED DURING OR AFTER THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23996822 ↗
• InjuryJan 5, 2026Material Fragmentation

  REFER TO H11 FOR FOLLOW-UP INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Unspecified Tissue Injury

  MAUDE report 23969359 ↗
• MalfunctionDec 31, 2025Unintended System Motion; Unintended System Motion

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED PROSTATECTOMY SURGICAL PROCEDURE, THE FENESTRATED BIPOLAR FORCEPS INSTRUMENT WRIST WAS NOT WORKING PROPERLY. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER, HOWEVER, NO FURTHER DETAILS COULD BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23936661 ↗
• InjuryDec 16, 2025Material Fragmentation; Material Fragmentation

  REFER TO H11 FOR FOLLOW-UP INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23823972 ↗
• MalfunctionDec 12, 2025Break; Break

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE FENESTRATED BIPOLAR FORCEPS INSTRUMENT TIPS WERE CHIPPED. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY.

  Patient problems: Insufficient Information

  MAUDE report 23786526 ↗
• MalfunctionDec 4, 2025Break; Break

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED MYOMECTOMY SURGICAL PROCEDURE, THE JAW OF THE FENESTRATED BIPOLAR FORCEPS INSTRUMENT WAS BROKEN. THE USER CONTINUED AND COMPLETED THE PROCEDURE AS PLANNED. 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 STATED THAT THEY DROPPED THE INSTRUMENT ON THE FLOOR AND PICKED IT UP AND NOTICED THAT THE JAW WAS COMPLETELY BROKEN OFF. NO FRAGMENTS FELL INTO THE PATIENT, AND THERE WAS NO PATIENT INJURY. NOTHING WAS MISSING FROM THE INSTRUMENT. THE USER REPLACED THE INSTRUMENT WITH A SPARE ONE. THE INSTRUMENT DID NOT COLLIDE WITH ANY OTHER INSTRUMENTS OR OTHER HARD MATERIAL DURING THE SURGICAL PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23722125 ↗