EndoWrist;daVinci Si 420205Recalls & reported problems

Summary

The FDA's MAUDE database contains 246 adverse event reports that list this exact device (DI 00886874111642), received between Mar 9, 2017 and Sep 29, 2026 — classified as 18 injuries, 227 malfunctions.

The most frequently reported specific device problem is “Material Split, Cut or Torn” (72 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 246 reports, in the reporter's own words as published by the FDA.

• OtherSep 29, 2026Arcing

  It was reported that during a da Vinci-assisted surgical procedure, the lead surgeon noticed sparks coming from the tip of the Fenestrated Bipolar Forceps instrument while performing uterine coagulation. The arcing appeared to originate from equipment, wrists, insulating materials and places. The arc grounded on patient anatomy when the bipolar energy was activated. Burnt insulation was noticed. The instrument tips did not collide with any other instrument or tool during procedure. It was reported that there was no patient injury. The procedure was completed as planned.

  Patient problems: Insufficient Information

  MAUDE report 50933194 ↗
• MalfunctionSep 23, 2026Material Split, Cut or Torn

  Patient problems: Insufficient Information

  MAUDE report 50875033 ↗
• MalfunctionApr 15, 2026Unintended Movement

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE FENESTRATED BIPOLAR FORCEPS INSTRUMENT FRONT END OF THE JAWS WAS UNABLE TO CLOSE. IT WAS FOUND THAT THE JAWS WERE BENT. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24890781 ↗
• MalfunctionMar 23, 2026No Device Output

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE 8 MM FENESTRATED BIPOLAR FORCEPS WAS NOT RECOGNIZED. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24670260 ↗
• MalfunctionMar 23, 2026Thermal Decomposition of Device; No Device Output

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE 8MM FENESTRATED BIPOLAR FORCEPS INSTRUMENT WAS NOT RECOGNIZED. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24670152 ↗
• MalfunctionMar 13, 2026Energy Output Problem

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE 8MM FENESTRATED BIPOLAR FORCEPS ENERGY WAS NOT RESPONDING. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY.

  Patient problems: Insufficient Information

  MAUDE report 24594738 ↗
• MalfunctionMar 2, 2026No Device Output

  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 24478541 ↗
• MalfunctionFeb 27, 2026Material Split, Cut or Torn

  IT WAS REPORTED THAT THERE WAS A BROKEN CABLE WITH A DA VINCI PRODUCT. THE CUSTOMER REPORTED EVENT HAS NO REPORT OF PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24466846 ↗
• MalfunctionFeb 25, 2026Material Split, Cut or Torn

  IT WAS REPORTED THAT THERE WAS A BROKEN CABLE WITH A DA VINCI PRODUCT. THE CUSTOMER REPORTED EVENT HAS NO REPORT OF PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24449460 ↗
• MalfunctionFeb 24, 2026Material Frayed

  IT WAS REPORTED THAT THERE WAS A FRAYED CABLE WITH A DA VINCI PRODUCT. THE CUSTOMER REPORTED EVENT HAS NO REPORT OF PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24425334 ↗
• MalfunctionFeb 23, 2026Material Frayed

  IT WAS REPORTED THAT THERE WAS A FRAYED CABLE WITH A DA VINCI PRODUCT. THE CUSTOMER REPORTED EVENT HAS NO REPORT OF PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24424238 ↗
• MalfunctionJan 9, 2026Material Split, Cut or Torn

  REFER TO H11 FOR FOLLOW-UP INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24029769 ↗
• MalfunctionJan 6, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE PULLEY WAS LOOSE IN THE WRIST ARTICULATION WHEN THE SURGEON TURNED THE INSTRUMENT. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY.

  Patient problems: Insufficient Information

  MAUDE report 23984698 ↗
• MalfunctionDec 19, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  REFER TO H11 FOR FOLLOW-UP INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23857478 ↗
• MalfunctionDec 19, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  REFER TO H11 FOR FOLLOW-UP INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23857363 ↗
• MalfunctionNov 12, 2025No Apparent Adverse Event; No Apparent Adverse Event

  IT WAS REPORTED THAT AFTER A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE FENESTRATED BIPOLAR FORCEPS INSTRUMENT STOPPED WORKING UN THE MIDDLE OF THE SURGICAL PROCEDURE. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: NO DAMAGE TO THE CONDUCTOR WIRE OBSERVED. NO MATERIAL MISSING OR DETACHED FROM THE PORTION OF THE INSTRUMENT THAT ENTERS THE PATIENT'S BODY. NO ALLEGATION OF UNCLAMPING FAILURE WHILE THE INSTRUMENT GRIPPING TISSUE. NO ISSUES RELATED TO NON-INTUITIVE OR UNCONTROLLED MOTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23537430 ↗
• MalfunctionNov 7, 2025Material Split, Cut or Torn; Material 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: Insufficient Information

  MAUDE report 23502184 ↗
• MalfunctionSep 19, 2025Thermal Decomposition of Device; Thermal Decomposition of Device

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE SURGEON FELT THAT THE 8MM FENESTRATED BIPOLAR FORCEPS INSTRUMENT WAS NOT FUNCTIONING PROPERLY. NO FRAGMENT FELL INTO THE PATIENT. THE PROCEDURE WAS COMPLETED BUT THE PATIENT OUTCOME WAS NOT PROVIDED. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE INSTRUMENT EXPERIENCED A LOSS OF CAUTERY DURING THE PROCEDURE. NO ARCING DURING THE PROCEDURE. NO ISSUES WITH THE JAWS OF THE INSTRUMENT MOVING IN THE WRONG/OPPOSITE DIRECTION OF THE SURGEON CONTROLS. THERE WAS NO INJURY TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23102447 ↗
• MalfunctionSep 19, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT AFTER A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE 8MM FENESTRATED BIPOLAR FORCEPS INSTRUMENT WAS OBSERVED TO HAVE A BROKEN CABLE AFTER IT WAS PULLED OUT. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23092907 ↗
• MalfunctionSep 9, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT THERE WAS A BROKEN CABLE WITH A DA VINCI PRODUCT. THE CUSTOMER REPORTED EVENT HAS NO REPORT OF PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23010807 ↗
• MalfunctionSep 9, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE PULLEY WAS BROKEN IN THE ARTICULATION. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY.

  Patient problems: Insufficient Information

  MAUDE report 22999817 ↗
• MalfunctionSep 3, 2025Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE FENESTRATED BIPOLAR FORCEPS INSTRUMENT CAN MOVE UPWARDS, TO THE LEFT, TO THE RIGHT, BUT NOT DOWNWARDS. THERE WAS NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22959043 ↗
• MalfunctionAug 21, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT THERE WAS A BROKEN CABLE WITH A DA VINCI PRODUCT. THE CUSTOMER REPORTED EVENT HAS NO REPORT OF PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22868090 ↗
• MalfunctionAug 20, 2025No Apparent Adverse Event; No Apparent Adverse Event

  REFER TO H11 FOR FOLLOW-UP INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22855269 ↗
• MalfunctionAug 19, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT THERE WAS A BROKEN CABLE WITH A DA VINCI PRODUCT. THE CUSTOMER REPORTED EVENT HAS NO REPORT OF PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22845314 ↗