EndoWrist SP 430151Recalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 00886874123447), received between Oct 22, 2025 and Sep 29, 2026 — classified as 4 injuries, 15 malfunctions.

The most frequently reported specific device problem is “Unintended Movement” (5 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 29, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50939853 ↗
• MalfunctionSep 22, 2026Unintended Movement

  It was reported that during a da Vinci-assisted surgical procedure, the front part of the 8mm Fenestrated Bipolar Forceps instrument did not fully engage. Upon removal and inspection, it was discovered that the instrument did not close completely even manually, so the arm was replaced with a new one and the surgery was performed.The procedure was completed with no reported injury.

  Patient problems: Insufficient Information

  MAUDE report 50850395 ↗
• MalfunctionAug 17, 2026Break

  Patient problems: Insufficient Information

  MAUDE report 50288334 ↗
• MalfunctionMay 29, 2026Unintended System Motion

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE SP FENESTRATED BIPOLAR FORCEPS INSTRUMENT DID NOT MOVE AS COMMANDED BY THE SURGEON. THE PROCEDURE WAS COMPLETED WITH NO REPORTS OF PATIENT INJURY. INTUITIVE FOLLOWED UP WITH THE CUSTOMER AND WAS ADVISED THAT IT IS UNKNOWN IF THE INSTRUMENT MOVED IN THE SAME DIRECTION OF THE SURGEON'S COMMANDS, OR IN THE OPPOSITE DIRECTION.

  Patient problems: Insufficient Information

  MAUDE report 25339147 ↗
• MalfunctionMay 1, 2026Unintended Movement

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE INSTRUMENT ARM DID NOT MOVE WELL. THERE WAS NO REPORT OF PATIENT INJURY.

  Patient problems: Insufficient Information

  MAUDE report 25062289 ↗
• MalfunctionApr 29, 2026Unintended Movement

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE SP FENESTRATED BIPOLAR FORCEPS INSTRUMENT FAILED TO RELEASE THE TISSUE AND THE JAWS HAD TO BE MANUALLY OPENED. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25035834 ↗
• MalfunctionApr 28, 2026Device Dislodged or Dislocated

  IT WAS REPORTED THAT PRIOR TO THE START OF A DA VINCI-ASSISTED SURGICAL PROCEDURE, A SINGLE PORT FENESTRATED BIPOLAR FORCEPS INSTRUMENT WAS FOUND TO HAVE MISALIGNED TIPS. THE CUSTOMER REPORTED EVENT HAD NO REPORT OF PATIENT INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE INSTRUMENT WAS NOT CONNECTED TO THE SYSTEM DURING THIS SURGERY. NO ARCING WAS REPORTED IN PRIOR SURGERIES.

  Patient problems: Insufficient Information

  MAUDE report 25011166 ↗
• InjuryApr 21, 2026Energy Output Problem

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

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 24945983 ↗
• MalfunctionApr 13, 2026Unintended Movement

  REFER TO H11 FOR FOLLOW-UP INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24863089 ↗
• MalfunctionMar 23, 2026Entrapment of Device

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED PARTIAL NEPHRECTOMY SURGICAL PROCEDURE, THE CUSTOMER INFORMED THE TECHNICAL SUPPORT ENGINEER (TSE) THAT THERE WAS AN ISSUE WITH THE FENESTRATED BIPOLAR FORCEPS (FBF) INSTRUMENT, AS THE JAWS WOULD NOT OPEN AT THE START OF THE CASE. THE CUSTOMER REPLACED THE FBF INSTRUMENT WITH A BACKUP INSTRUMENT TO CONTINUE WITH THE PROCEDURE. THE CUSTOMER LATER CONFIRMED THAT THEY EXPERIENCED THE SAME ISSUE ON THE SECOND INSTRUMENT AND THE SYSTEM HAD NOT BEEN USED SINCE. THE PROCEDURE WAS COMPLETED AS PLANNED WITH NO REPORTED ISSUE. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED ADDITIONAL INFORMATION: THE REPORTER CONFIRMED THAT THE FIRST FBF INSTRUMENT EXPERIENCED THE JAW-NOT-OPENING ISSUE WHILE GRASPING TISSUE. HOWEVER, AS THE TISSUE WAS THIN, IT WAS ABLE TO BE REMOVED FROM THE JAW WITHOUT CAUSING HARM. THE SECOND INSTRUMENT ISSUE OCCURRED WHEN WAS NOT GRASPING TISSUE. THE CUSTOMER REMOVED THE SECOND INSTRUMENT AND REPLACED IT WITH A DIFFERENT INSTRUMENT TO CONTINUE WITH THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24665216 ↗
• MalfunctionMar 16, 2026Break

  IT WAS REPORTED THAT DURING DA VINCI-ASSISTED SURGICAL PROCEDURE, THE FENESTRATED BIPOLAR FORCEPS COULD NOT BE REMOVED AS THE RELEASE BUTTON GOT STUCK. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY.

  Patient problems: Insufficient Information

  MAUDE report 24612557 ↗
• InjuryMar 9, 2026Detachment of Device or Device Component

  REFER TO H11 FOR FOLLOW-UP INFORMATION.

  Patient problems: Foreign Body In Patient

  MAUDE report 24544978 ↗
• MalfunctionMar 2, 2026Unintended System Motion

  REFER TO H11 FOR FOLLOW-UP INFORMATION.

  Patient problems: Insufficient Information

  MAUDE report 24490303 ↗
• MalfunctionFeb 14, 2026Entrapment of Device; Difficult to Remove

  REFER TO H11 FOR FOLLOW-UP INFORMATION.

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

  MAUDE report 24340965 ↗
• MalfunctionFeb 11, 2026Thermal Decomposition of Device

  IT WAS REPORTED THAT AFTER A DA VINCI-ASSISTED SURGICAL PROCEDURE, USER OBSERVED SOME MELT MARKS ON SINGLE PORT (SP) FENESTRATED BIPOLAR FORCEPS INSTRUMENT. THE PROCEDURE WAS COMPLETED AS PLANNED WITH NO REPORTED INJURIES. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED ADDITIONAL INFORMATION: THE REPORTER CONFIRMED THAT NO ARCING WAS OBSERVED DURING THE PROCEDURE. THERE WERE NO OTHER INSTRUMENTS IN USE THAT COULD HAVE CONTRIBUTED TO AN ARCING EVENT, AND NO INJURY TO THE PATIENT WAS REPORTED. THE INSTRUMENT WAS INSPECTED PRIOR TO USE, AND NO DAMAGE OR ANYTHING OUT OF THE ORDINARY WAS NOTED. THE SURGEON BELIEVES THAT THE THERMAL DAMAGE TO THE INSTRUMENT WAS CAUSED BY THE CONTINUOUS USE OF THE FENESTRATED BIPOLAR FORCEPS FOR A LONG TIME WITHOUT UTILIZING THE AUTOSTOP FEATURE. THERE WAS NO COLLISION WITH AN ENERGY INSTRUMENT DURING THE PROCEDURE, AND NO PHOTOGRAPHIC IMAGES OR VIDEO RECORDINGS OF THE PROCEDURE ARE AVAILABLE FOR ISI REVIEW.

  Patient problems: Insufficient Information

  MAUDE report 24317913 ↗
• MalfunctionFeb 5, 2026Unintended Movement

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED MYOMECTOMY SURGICAL PROCEDURE, THE ARM DOES NOT MOVE WELL DURING SURGERY. 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 REPORTED ISSUE WAS WITH THE FENESTRATED BIPOLAR FORCEPS INSTRUMENT. THE ISSUE OCCURRED WITH THE SURGEON¿S HEAD INSIDE THE SURGEON CONSOLE¿S HIGH RESOLUTION STEREO VIEWER WHILE THE SURGEON WAS ATTEMPTING TO MANIPULATE THE INSTRUMENTS FROM THE SURGEON SIDE CONSOLE (SSC). THE CONTACT PERSON STATED THAT IT WAS UNKNOWN WHAT THE EXACT MOVEMENT ISSUE WITH THE INSTRUMENT. AS PER THE NURSE, THE SURGEON, WHILE OPERATING AT THE CONSOLE, MENTIONED THE INSTRUMENT WAS NOT MOVING AS DESIRED, BUT THE EXACT NATURE OF THE PROBLEM WAS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24269822 ↗
• MalfunctionDec 30, 2025Entrapment of Device; Difficult to Open or Close; Entrapment of Device; Difficult to Open or Close

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED OVARIAN CYSTECTOMY SURGICAL PROCEDURE, IT WAS REPORTED THAT THE SINGLE PORT FENESTRATED BIPOLAR FORCEPS INSTRUMENT TIP DID NOT OPEN WHEN HOLDING THE INSTRUMENT. ATTEMPTS WERE MADE TO OPEN THE TIP BY TURNING THE DIAL AND PRESSING THE DISENGAGEMENT BUTTON, BUT THESE ACTIONS DID NOT RESOLVE THE ISSUE. THE PROCEDURE WAS CONVERTED TO A TRADITIONAL LAPAROSCOPIC SURGERY WITH NO REPORTED INJURY. THERE WAS A PROCEDURE DELAY OF 15 - 30 MINUTES. INTUITIVE SURGICAL, INC. (ISI) CONTACTED THE CUSTOMER AND OBTAINED THE FOLLOWING INFORMATION: THE INSTRUMENT WAS INSPECTED PRIOR TO USE, AND NOTHING WAS OUT OF THE ORDINARY. THE PROCEDURE WAS AN OVARIAN CYST PROCEDURE, AND THE SURGEON WAS DISSECTING UTERUS TISSUE. THE ISSUE DID NOT OCCUR AFTER A SYSTEM FAULT. THE PROCEDURE WAS CONVERTED TO A LAPAROSCOPIC SURGERY, THEN THE SURGEON REMOVED THE TISSUE THAT WAS STUCK INTO THE INSTRUMENT BY USING A LAPAROSCOPIC INSTRUMENT. THE TISSUE THAT WAS STUCK IN THE INSTRUMENT WAS TISSUE THAT WAS ORIGINALLY INTENDED TO BE REMOVED DURING THE PROCEDURE. THERE WAS NO UNEXPECTED TISSUE REMOVAL AND THERE WAS NO BLEEDING. THERE WERE NO INCREASE PORT INCISION OR ADDITIONAL POR

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23928120 ↗
• InjuryDec 15, 2025Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED OVARIAN CYSTECTOMY PROCEDURE, THE TIP OF THE FENESTRATED BIPOLAR FORCEPS (FBF) INSTRUMENT BROKE AND A FRAGMENT FELL INSIDE THE PATIENT. THE EVENT OCCURRED DURING INSTRUMENT REMOVAL. THE FRAGMENT(S) WERERRETRIEVED DURING THE SAME SURGICAL PROCEDURE BY IRRIGATION AND SUCTIONING. THEY WERE UNABLE TO CONFIRM THAT ALL FRAGMENTS WERE RETRIEVED. THE PROCEDURE WAS COMPLETED ROBOTICALLY USING BACKUP FBF INSTRUMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23811542 ↗
• InjuryOct 22, 2025Break; Break

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED PARTIAL NEPHRECTOMY SURGICAL PROCEDURE, WHEN THE SURGEON ATTEMPTED TO GRASP THE TISSUE, THE TIP OF THE FENESTRATED BIPOLAR FORCEPS INSTRUMENT WAS MISSING. THE SURGEON WAS ABLE TO RETRIEVE THE FRAGMENT. THE PROCEDURE WAS COMPLETED AS PLANNED. AN X-RAY WAS PERFORMED TO CONFIRM NO FRAGMENTS REMAINED INSIDE THE PATIENT. 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 23363307 ↗