EndoWrist;daVinci Si 420172Recalls & reported problems

Summary

The FDA's MAUDE database contains 188 adverse event reports that list this exact device (DI 00886874111475), received between Jan 3, 2020 and Apr 13, 2026 — classified as 9 injuries, 179 malfunctions.

The most frequently reported specific device problem is “Material Split, Cut or Torn” (44 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 188 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 13, 2026Energy Output Problem

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE 8MM MARYLAND BIPOLAR FORCEPS COULD NOT OUTPUT ENERGY. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY OR HARM TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24860526 ↗
• MalfunctionJan 30, 2026Material Split, Cut or Torn

  REFER TO H11 FOR FOLLOW-UP INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24228391 ↗
• MalfunctionJan 23, 2026Material Split, Cut or Torn

  REFER TO H11 FOR FOLLOW-UP INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24170133 ↗
• MalfunctionNov 8, 2025Energy Output Problem; Energy Output Problem

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE 8MM MARYLAND BIPOLAR FORCEPS INSTRUMENT ENERGY CANNOT BE EXCITED. THE PROCEDURE WAS COMPLETED WITH NO REPORTED PATIENT INJURY. ISI FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: NO ARCING WAS OBSERVED DURING THE PROCEDURE, INDICATING THAT THE EQUIPMENT DID NOT GENERATE ANY ENERGY OUTPUT. NO PATIENT INJURY OR ADVERSE EVENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23504626 ↗
• MalfunctionNov 4, 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 23471115 ↗
• MalfunctionSep 9, 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 23010919 ↗
• MalfunctionAug 26, 2025Material Frayed; Material Frayed

  REFER TO H11 FOR FOLLOW-UP INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22900226 ↗
• MalfunctionAug 22, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT PRIOR TO THE START OF A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE OR NURSE CHECKED AND FOUND THAT THE CAUTERY PIN OF MARYLAND BIPOLAR FORCEPS IS LOOSEN AND FELL OUT. THE ELECTRIC CABLE IS STILL ATTACHED BUT NOT WELL. THEY USE BACK UP INSTRUMENT TO START THE PROCEDURE. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22878600 ↗
• MalfunctionAug 5, 2025Material Frayed; Material Frayed

  REFER TO H11 FOR FOLLOW-UP INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22721375 ↗
• MalfunctionAug 1, 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 22691221 ↗
• MalfunctionJul 18, 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 22547666 ↗
• MalfunctionJul 14, 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 22501847 ↗
• MalfunctionJun 21, 2025Smoking; Smoking

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED PROSTATECTOMY SURGICAL PROCEDURE, SMOKE BEGAN TO COME OUT OF THE MARYLAND BIPOLAR FORCEPS INSTRUMENT. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22303572 ↗
• MalfunctionJun 12, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, NO NOTIFICATION WAS MADE DURING THE SURGERY, A CUT CORD WAS FOUND. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22198460 ↗
• MalfunctionJun 11, 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 22189723 ↗
• MalfunctionApr 16, 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 21845993 ↗
• MalfunctionApr 3, 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 21768342 ↗
• MalfunctionFeb 11, 2025No Device Output; No Device Output

  REFER TO H11 FOR FOLLOW-UP INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21352434 ↗
• MalfunctionFeb 11, 2025Thermal Decomposition of Device; Thermal Decomposition of Device

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE MARYLAND BIPOLAR FORCEPS INSTRUMENT SPARKED DURING ENERGY ACTIVATION. THE ISSUE CAUSED THE PLASTIC ON THE TIP TO MELT. 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 EVENT OCCURRED WHILE CAUTERIZING. THE MONOPOLAR CURVED SCISSORS WERE ALSO USED. THE INSTRUMENT WAS NOT IN CONTACT WITH TISSUE WHEN THE ARCING OCCURRED. THERE WAS NO INJURY TO THE PATIENT AND THE INSTRUMENT DID NOT COLLIDE WITH THE OTHER INSTRUMENT NOR WAS IT IN CONTACT WITH STAPLES, CLIPS OR SUTURES WHILE ENERGIZED. IT IS UNCERTAIN IF THE JAWS WERE IMMERSED IN LIQUID OR CONTAMINATED BY CARBONIZED TISSUE (BIO DEBRIS) PRIOR TO ACTIVATING THE INSTRUMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21352430 ↗
• MalfunctionFeb 8, 2025Break; Material Split, Cut or Torn; Break; Material Split, Cut or Torn

  REFER TO H11 FOR FOLLOW-UP INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21340251 ↗
• MalfunctionJan 17, 2025Thermal Decomposition of Device; Thermal Decomposition of Device

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE 8MM MARYLAND BIPOLAR FORCEPS INSTRUMENT TIP SPARKED AFTER ACTIVATING THE AUTO CUT FUNCTION. THE INSTRUMENT WAS REMOVED, AND INSPECTION FOUND THE RESIN PART OF THE TIP BURNT. A BACKUP INSTRUMENT WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORT OF ANY FRAGMENTS FALLING INSIDE THE PATIENT. NO KNOWN IMPACT OR PATIENT CONSEQUENCE WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21185762 ↗
• MalfunctionJan 14, 2025Energy Output Problem; Energy Output Problem

  IT WAS REPORTED DURING THE DA VINCI ASSISTED SURGICAL PROCEDURE; THE MARYLAND BIPOLAR FORCEPS INSTRUMENT HAD NO ENERGY. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21146686 ↗
• MalfunctionDec 6, 2024Energy Output Problem; Energy Output Problem

  IT WAS REPORTED THAT DURING DA VINCI-ASSISTED SURGICAL PROCEDURE, THE MARYLAND BIPOLAR FORCEPS WAS FOUND TO HAVE POOR ROTATION AND POOR ENERGY DISTRIBUTION. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: WHEN APPEALING FOR INSTRUMENTS IN THE OPERATING ROOM, THERE WAS NO FEEDBACK OF WIRE DAMAGE, ONLY THE ISSUE OF ENERGY DISTRIBUTION WAS REPORTED, AND THE STAFF COULD NOT CONFIRM WHETHER THE WIRE WAS DAMAGED OR NOT. NURSES AND SURGEONS REPORTED THAT NO ARC WAS SEEN DURING THE OPERATION. THE HOSPITAL HAS REPORTED THAT THERE HAVE BEEN NO ADVERSE EVENTS CAUSED BY THE DEVICE. ATTACHED ARE PICTURES OF THE EQUIPMENT. THE HOSPITAL IS UNABLE TO PROVIDE PATIENT INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20861642 ↗
• MalfunctionNov 23, 2024Thermal Decomposition of Device; Thermal Decomposition of Device

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE 8MM MARYLAND BIPOLAR FORCEPS INSTRUMENT'S MOUTH MOVEMENT WAS NOT FREE AND COULD NOT REACH THE SURGICAL SITE. THE SURGEON COULD NOT PERFORM THE OPERATION NORMALLY. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: ARCING WAS NOT OBSERVED DURING THE PROCEDURE. NO PATIENT INJURY OR HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20766185 ↗
• MalfunctionNov 19, 2024Thermal Decomposition of Device; Thermal Decomposition of Device

  REFER TO H11 FOR FOLLOW-UP INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20720066 ↗