EndoWrist SP 431150Recalls & reported problems

Summary

The FDA's MAUDE database contains 25 adverse event reports that list this exact device (DI 00886874124055), received between Aug 4, 2025 and Sep 29, 2026 — classified as 1 injury, 24 malfunctions.

The most frequently reported specific device problem is “Break” (11 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 25 reports, in the reporter's own words as published by the FDA.

• InjurySep 29, 2026Entrapment of Device

  Patient problems: Unspecified Tissue Injury

  MAUDE report 50941331 ↗
• MalfunctionSep 23, 2026Material Twisted/Bent

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50875245 ↗
• MalfunctionSep 23, 2026Difficult to Open or Close

  It was reported that after a da Vinci-assisted surgical procedure, the customer observed the 6mm Force Bipolar instrument's button which allows the jaws to open was not holding. No known impact or patient consequence was reported. Intuitive Surgical Inc. (ISI) followed up with the customer: It was confirmed the instrument jaws were stuck in the closed position.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50873341 ↗
• MalfunctionSep 22, 2026No Apparent Adverse Event

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50861048 ↗
• MalfunctionSep 4, 2026Thermal Decomposition of Device

  It was reported that during central processing, Force Bipolar had a hole in the plastic of the jaw. It appears to be due to plastic melting. There was no report of patient involvement

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50622118 ↗
• MalfunctionAug 12, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50218069 ↗
• MalfunctionMay 15, 2026Break

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE SINGLE PORT (SP) FORCE BIPOLAR INSTRUMENT WAS MOVING ABNORMALLY AND WAS NOT OPENING PROPERLY. UPON INSPECTING THE INSTRUMENT, IT WAS CONFIRMED THAT THE SHAFT WAS INCOMPLETE AND BROKEN. AS THE SURGERY WAS ALREADY FINISHED, IT WAS TERMINATED IN THAT STATE. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY.

  Patient problems: Insufficient Information

  MAUDE report 25189712 ↗
• MalfunctionApr 30, 2026Break; Device Dislodged or Dislocated; Unintended Movement

  IT WAS REPORTED THAT DURING DA VINCI-ASSISTED SURGICAL PROCEDURE, THE FORCE BIPOLAR INSTRUMENT HAD ISSUE WITH GRIPPING FORCE. IT WAS UNKNOWN IF ANY FRAGMENT FELL INTO THE PATIENT. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. ISI FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: DURING THE PROCEDURE, THE INSTRUMENT COULDN¿T GRASP THE TISSUE. IT WAS PREDICTED THAT THE WRIST OF INSTRUMENT MAY BE DAMAGED. NO FRAGMENT FELL INTO THE PATIENT. THERE WAS NO REPORTED INJURY.

  Patient problems: Insufficient Information

  MAUDE report 25051068 ↗
• MalfunctionApr 29, 2026Device Dislodged or Dislocated; Material Twisted/Bent

  IT WAS REPORTED THAT PRIOR TO THE START OF A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE FORCE BIPOLAR INSTRUMENT'S JAWS WERE BENT. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. ISI FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE INSTRUMENT'S WRIST DOES NOT APPEAR TO BE UNHINGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25036994 ↗
• MalfunctionApr 24, 2026Break

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED MYOMECTOMY SURGICAL PROCEDURE, THE CONNECTION POINT OF THE 6MM FORCE BIPOLAR EXTEND INSTRUMENT DETACHED IMMEDIATELY AFTER USE. IT WAS AT THE END OF THE SURGERY, IT WAS NOT USED IN THE PATIENT AFTER THE INCIDENT. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24990386 ↗
• MalfunctionApr 15, 2026Entrapment of Device

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED BILATERAL INGUINAL LYMPHADENECTOMY SINGLE PORT SURGICAL PROCEDURE, THE FORCE BIPOLAR INSTRUMENT ENTRAPPED LYMPH NODE FATTY TISSUE. THIS EVENT OCCURRED WHEN THE TISSUE WAS GRASPED, BUT THE FORCE BIPOLAR INSTRUMENT WOULD NOT OPEN. THE INSTRUMENT RELEASE KIT (IRK) FAILED TO SUCCESSFULLY OPEN THE JAWS OF THE INSTRUMENT. THIS WAS A LYMPH NODE DISSECTION PROCEDURE, AND THE MONOPOLAR CURVED SCISSORS INSTRUMENT WAS THEN USED TO CUT THE FATTY LYMPH NODE TISSUE AROUND THE JAWS OF THE INSTRUMENT IN ORDER TO REMOVE THE INSTRUMENT. THE SURGEON CONFIRMED THERE WAS NO SIGNIFICANT BLEEDING, HOWEVER, IT IS UNKNOWN IF CAUTERY WAS USED. IN ADDITION, THE SURGEON REPORTED THERE WAS NO INJURY TO THE PATIENT. THE SURGERY WAS COMPLETED WITH NO OTHER COMPLICATIONS. ON 18-MAR-2026, INTUITIVE SURGICAL, INC. (ISI) RECEIVED USER FACILITY REPORT 4900320000-2026-8003 STATING: "DURING THE PROCEDURE, THE INSTRUMENT WAS GRASPING TISSUE AND WOULD NOT UNGROUP. TROUBLESHOOTING WAS PREFORMED BUT THE SURGEON HAD TO CUT THE TISSUE THAT THE INSTRUMENT WAS GRASPING IN ORDER TO REMOVE THE INSTRUMENT FROM THE ROBOT."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24884315 ↗
• MalfunctionApr 13, 2026Material Twisted/Bent

  IT WAS REPORTED THAT DURING CENTRAL PROCESSING, THE FORCE BIPOLAR INSTRUMENT JAWS WERE BENT. THERE WAS NO REPORT OF PATIENT INVOLVEMENT OR PATIENT INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED ADDITIONAL INFORMATION: THE WRIST OF THE INSTRUMENT APPEARS TO BE UNHINGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24858574 ↗
• MalfunctionMar 18, 2026Break

  IT WAS REPORTED THAT PRIOR TO THE START OF A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE 6MM FORCE BIPOLAR INSTRUMENT TIP WAS BENT AND BROKE OFF. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24628841 ↗
• MalfunctionMar 18, 2026

  DURING THE PROCEDURE, THE INSTRUMENT WAS GRASPING TISSUE AND WOULD NOT UNGROUP. TROUBLESHOOTING WAS PREFORMED BUT THE SURGEON HAD TO CUT THE TISSUE THAT THE INSTRUMENT WAS GRASPING IN ORDER TO REMOVE THE INSTRUMENT FROM THE ROBOT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24625853 ↗
• MalfunctionMar 11, 2026Break

  IT WAS REPORTED DURING THE DA VINCI ASSISTED SURGICAL PROCEDURE, THE FORCE BIPOLAR INSTRUMENT WAS BROKEN. THE CUSTOMER REPORTED EVENT HAS NO REPORT OF PATIENT INJURY. FOLLOW-UP WAS ATTEMPTED TO GATHER MORE INFORMATION, BUT THE CUSTOMER WAS NOT ABLE TO PROVIDE ANY ADDITIONAL DETAILS RELATED TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24571897 ↗
• MalfunctionMar 3, 2026Unintended System Motion

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE FORCE BIPOLAR INSTRUMENT WOULD ENGAGE IN A DIFFERENT DIRECTION THAN THE SURGEON WAS TRYING. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24503552 ↗
• MalfunctionFeb 13, 2026Break

  IT WAS REPORTED THAT DURING CENTRAL PROCESSING, THE WHITE SEAL AT THE TIP OF THE FORCE BIPOLAR INSTRUMENT WAS COMING OUT FRAYED. THERE WAS NO REPORT OF PATIENT INVOLVEMENT. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: DAMAGE TO THE INSTRUMENT WAS IDENTIFIED DURING CENTRAL PROCESSING AND NOT DURING A SURGICAL PROCEDURE. THERE WERE NO REPORTS OF FRAGMENTS FALLING FROM THE DEVICE WHILE IT WAS USED WITHIN A PATIENT, AND NO MATERIAL APPEARS TO BE MISSING OR DETACHED, THOUGH THE INSTRUMENT WAS COMING APART. THE PATIENT HAS NOT RETURNED TO THE HOSPITAL WITH ANY POST-SURGICAL COMPLICATIONS RELATED TO RETAINED FOREIGN MATERIAL.

  Patient problems: Insufficient Information

  MAUDE report 24330009 ↗
• MalfunctionJan 28, 2026Break; Material Fragmentation

  IT WAS REPORTED THAT PRIOR TO STARTING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE SINGLE PORT FORCE BIPOLAR INSTRUMENT WAS FOUND WITH THE JOINT AND TIP CONNECTION AREA SEPARATED. THERE WAS NO REPORT OF ANY FRAGMENTS FALLING INSIDE THE PATIENT, AND A BACKUP INSTRUMENT OF THE SAME KIND WAS USED TO COMPLETE THE PROCEDURE. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE CUSTOMER INDICATED THAT THE TIP DID NOT DETACH FROM THE JOINT OUTSIDE THE COVERAGE OF THE SP SHEATH, AND NO FRAGMENT FELL INSIDE THE PATIENT'S ANATOMY DURING PREVIOUS USE; HOWEVER, IT IS UNKNOWN IF ANY PIECE OR MATERIAL WAS MISSING. THE PROCEDURE WAS COMPLETED USING A BACKUP INSTRUMENT OF THE SAME TYPE, WITH NO KNOWN IMPACT OR PATIENT CONSEQUENCE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24204491 ↗
• MalfunctionOct 30, 2025Difficult to Open or Close; Difficult to Open or Close

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE JAWS OF THE 6 MM EXTENDED RANGE FORCE BIPOLAR INSTRUMENT WOULD NOT OPEN. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. FOLLOW-UP WAS ATTEMPTED TO GATHER MORE INFORMATION, BUT THE CUSTOMER WAS NOT ABLE TO PROVIDE ANY ADDITIONAL DETAILS RELATED TO THE EVENT/INSTRUMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23430173 ↗
• MalfunctionOct 27, 2025No Apparent Adverse Event; No Apparent Adverse Event

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE FORCE BIPOLAR 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: THE REPORTED DAMAGE TO THE DEVICE OCCURRED OUTSIDE OF A SURGICAL PROCEDURE AND NOT WHILE IT WAS IN USE WITH A PATIENT. THERE WERE NO REPORTS OF FRAGMENTS FALLING FROM THE DEVICE DURING PATIENT USE. SINCE NO FRAGMENTS ENTERED THE PATIENT, NO SPECIFIC ACTIONS WERE NEEDED, AND THE PATIENT HAS NOT RETURNED TO THE HOSPITAL WITH POST-SURGICAL COMPLICATIONS RELATED TO RETAINED FOREIGN MATERIAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23397973 ↗
• MalfunctionOct 26, 2025Break; Break

  REFER TO H11 FOR FOLLOW-UP INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23387911 ↗
• MalfunctionSep 11, 2025Difficult to Open or Close; Difficult to Open or Close

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE THAT THE TIP OF THE FORCE BIPOLAR INSTRUMENT WAS FOUND TO BE MISALIGNED; THE JAWS WOULD NOT OPEN. THE PROCEDURE WAS COMPLETED WITH NO REPORTS OF PATIENT INJURY. INTUITIVE FOLLOWED UP WITH THE CUSTOMER AND WAS ADVISED THAT THERE IS NO ADDITIONAL INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23028631 ↗
• MalfunctionAug 28, 2025Break; Break

  REFER TO H11 FOR FOLLOW-UP INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22919074 ↗
• MalfunctionAug 26, 2025Break; Material Twisted/Bent; Break; Material Twisted/Bent

  IT WAS REPORTED THAT THE FORCE BIPOLAR INSTRUMENT'S TIP WAS NOT CLOSING PROPERLY. NO KNOWN IMPACT OR PATIENT CONSEQUENCE WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22899448 ↗
• MalfunctionAug 4, 2025Unintended System Motion; Unintended System Motion

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED RETROPERITONEAL ANTERIOR PARTIAL NEPHRECTOMY SURGICAL PROCEDURE, INTUITIVE SURGICAL, INC. (ISI) CLINICAL SALES REPRESENTATIVE (CSR) INFORMED TECHNICAL SUPPORT ENGINEER (TSE) THAT A NON-INTUITIVE MOTION MESSAGE APPEARED. THE CUSTOMER RESEATED STERILE ADAPTER (SA) AND EXTENDED RANGE FORCE BIPOLAR (ERFB) INSTRUMENT ON PATIENT SIDE MANIPULATOR (PSM) 1 TWICE, BUT THE ISSUE WAS NOT RESOLVED. THE CUSTOMER REPLACED THE ERFB INSTRUMENT WITH FENESTRATED BIPOLAR FORCEPS (FBF) INSTRUMENT TO RESOLVE THE ISSUE. THE PROCEDURE WAS COMPLETING AS PLANNED WITH NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22701061 ↗