EndoWrist;daVinci Si 420183Recalls & reported problems

Summary

The FDA's MAUDE database contains 193 adverse event reports that list this exact device (DI 00886874111536), received between Feb 13, 2017 and Apr 28, 2026 — classified as 10 injuries, 183 malfunctions.

The most frequently reported specific device problem is “Break” (62 reports).

1 FDA recall record name this device's identifier, 1 still open.

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.

Recalls naming this device

1. Dec 9, 2025Class IIOpen, Classified

   Due to increased in complaints regarding frayed or broken pitch cables on reusable surgical instruments

   Z-1701-2026 · Root cause: Process change control · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 193 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 28, 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 25022371 ↗
• MalfunctionApr 15, 2026Thermal Decomposition of Device; Energy Output Problem

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE PERMANENT CAUTERY HOOK (PCH) INSTRUMENT HAD NO ENERGY OUTPUT. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24880803 ↗
• MalfunctionFeb 20, 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 24407417 ↗
• MalfunctionFeb 19, 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 24395815 ↗
• MalfunctionJan 27, 2026Energy Output Problem

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE PERMANENT CAUTERY HOOK INSTRUMENT WAS NOT GENERATING ELECTRICAL ENERGY. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24194231 ↗
• MalfunctionJan 17, 2026Arcing

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE PERMANENT CAUTERY HOOK INSTRUMENT WAS LEAKING ELECTRICITY. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24106133 ↗
• MalfunctionDec 29, 2025Arcing; Arcing

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE 8MM PERMANENT CAUTERY HOOK (PCH) INSTRUMENT'S TIP EXPERIENCED AN ELECTRICAL LEAKAGE. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23917560 ↗
• MalfunctionSep 16, 2025Thermal Decomposition of Device; Thermal Decomposition of Device

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE SURGEON NOTICED ABNORMAL ELECTRICAL ENERGY REGARDING THE 8MM PERMANENT CAUTERY HOOK (PCH) INSTRUMENT AND THERE WERE SIGNS OF CHARRING AT THE TIP. NO FRAGMENT FELL INTO THE PATIENT. 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 CUSTOMER MEANT NO ENERGY WHEN THEY STATED THEY EXPERIENCED 'ABNORMAL ELECTRICAL ENERGY'. NO EVENT DETAILS WERE PROVIDED. ARCING WAS OBSERVED DURING THE PROCEDURE, WHILE DISSECTING, AND WHEN USING A FENESTRATED BIPOLAR FORCEPS INSTRUMENT. THE ARC APPEARED TO ORIGINATE FROM THE SUBJECT INSTRUMENT; THE INSTRUMENT TIPS WERE IN CONTACT WITH TISSUE, BUT THEY DID NOT TOUCH ANY STAPLES, CLIPS, OR SUTURES WHILE ENERGIZED. THE JAWS WERE NOT IMMERSED IN LIQUID OR CONTAMINATED BY CARBONIZED TISSUE (BIO DEBRIS) PRIOR TO ACTIVATING THE INSTRUMENT. THE SURGEON ATTRIBUTES THE THERMAL DAMAGE OBSERVED AT THE INSTRUMENT TO A QUALITY ISSUE. THE INSTRUMENT DID NOT COLLIDE WITH AN ENERGY INSTRUMENT DURING THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23068560 ↗
• 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 22691248 ↗
• 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 22501751 ↗
• MalfunctionFeb 12, 2025Thermal Decomposition of Device; Arcing; Thermal Decomposition of Device; Arcing

  REFER TO H11 FOR FOLLOW-UP INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21361647 ↗
• MalfunctionOct 19, 2024Break; Break

  IT WAS REPORTED THAT THE CUSTOMER OBSERVED THAT THE 8MM PERMANENT CAUTERY HOOK INSTRUMENT WAS BROKEN AND THE EQUIPMENT WAS BROKEN UPON OPENING THE PACKAGE. THERE WAS NO REPORT OF PATIENT INVOLVEMENT.

  Patient problems: Insufficient Information

  MAUDE report 20488918 ↗
• MalfunctionJun 1, 2024Arcing; Arcing

  REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19442710 ↗
• MalfunctionMay 22, 2024Arcing; Arcing

  REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19378260 ↗
• MalfunctionMay 15, 2024Unintended System Motion; Material Split, Cut or Torn; Unintended System Motion; Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, WHEN PERFORMING A ROTATIONAL MOVEMENT TO START THE CUT, THE PERMANENT CAUTERY HOOK (PCH) PRESENTED RESISTANCE TO ROTATION, MAKING THE CUTTING AMPLITUDE DIFFICULT. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19317426 ↗
• MalfunctionMay 9, 2024Energy Output Problem; Energy Output Problem

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE PERMANENT CAUTERY HOOK INSTRUMENT HAD NO ENERGY OUTPUT. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19280281 ↗
• MalfunctionApr 18, 2024Arcing; Arcing

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED PULMONARY LOBECTOMY SURGICAL PROCEDURE, THE PERMANENT CAUTERY HOOK (PCH) INSTRUMENT HAD A LEAKAGE. THE PROCEDURE WAS COMPLETED WITH A BACKUP PCH INSTRUMENT AND WITH NO FURTHER ISSUE REPORTED. THERE WAS NO KNOWN IMPACT OR PATIENT CONSEQUENCE REPORTED. ISI FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE REPORTER CONFIRMED THAT THERE WAS NO ELECTRICAL DISCHARGE. THE INSTRUMENT WAS INSPECTED BEFORE USE AND THERE WAS NO DAMAGE OR ANYTHING OUT OF THE ORDINARY. THE REPORTER CONFIRMED THAT NO ARCING WAS OBSERVED. ADDITIONALLY, THE REPORTER CONFIRMED THAT THE INSTRUMENT'S TIPS DID NOT COLLIDE WITH ANY OTHER INSTRUMENTS OR TOOLS DURING THE PROCEDURE. THERE WAS NO PATIENT INJURY. THERE WAS NO REPORT OF POST-SURGICAL COMPLICATION AND THE PATIENT DID NOT RETURNED TO THE HOSPITAL. NO IMAGES OR VIDEOS ARE AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19140620 ↗
• InjuryMar 26, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED ISOLATED NISSEN FUNDOPLICATION SURGICAL PROCEDURE, THE PERMANENT CAUTERY HOOK INSTRUMENT BROKE AND FRAGMENTS FELL INSIDE THE PATIENT. THE CLINICAL TERRITORY ASSOCIATE (CTA) STATED ALL FRAGMENTS HAVE BEEN REMOVED FROM THE PATIENT. THE CUSTOMER REPLACED THE INSTRUMENT WITH A BACKUP AND COMPLETED THE PROCEDURE. INTUITIVE SURGICAL INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE HOOK HAD COME LOOSE, AN IMAGE OF THE DAMAGE WAS PROVIDED FOR REVIEW. A RETURN OF THE INSTRUMENT WAS MADE BY THE PHARMACY BUT THE REPORTER DID NOT HAVE THE INFORMATION. THE HOOK WAS RETRIEVED WITH A CELIO CLIP. THE ISSUE OCCURRED DURING DISSECTION. THE INSTRUMENT WAS IN USE FOR APPROXIMATELY 45 MINS PRIOR TO THE INCIDENT. ACCORDING TO THE REPORTER, IT WAS A VERY OLD INSTRUMENT THAT HAD MULTIPLE STERILIZATION CYCLES. THE SURGEON NOTICED THAT THE INSTRUMENT DID NOT COAGULATE WELL. THE INSTRUMENT DID NOT COLLIDE WITH ANY OTHER INSTRUMENTS OR OTHER HARD MATERIAL DURING THE SURGICAL PROCEDURE. THE INSTRUMENT WAS NOT REMOVED BEFORE IT RUPTURED. DURING FINAL REMOVAL OF THE INSTRUMENT, THE WRIST WAS STRAIGHTENED THE SU

  Patient problems: Foreign Body In Patient

  MAUDE report 18979047 ↗
• MalfunctionMar 13, 2024Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT, THE PERMANENT CAUTERY HOOK (PCH) INSTRUMENT HAD A BREAK IN THE STEEL CABLE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18892015 ↗
• MalfunctionFeb 29, 2024Material Fragmentation; Material Fragmentation

  REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.

  Patient problems: Insufficient Information

  MAUDE report 18809494 ↗
• MalfunctionFeb 23, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, A PERMANENT CAUTERY HOOK INSTRUMENT HAD CORROSION. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18765074 ↗
• MalfunctionJan 27, 2024Material Fragmentation; Material Fragmentation

  REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18592595 ↗
• MalfunctionJan 25, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED MYOMECTOMY SURGICAL PROCEDURE, THE PERMANENT CAUTERY HOOK INSTRUMENT WAS FOUND TO HAVE A BROKEN CABLE. THERE WAS NO REPORT OF FRAGMENT(S) FALLING INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITH A BACKUP INSTRUMENT OF SAME KIND. NO KNOWN IMPACT OR PATIENT CONSEQUENCE WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18577595 ↗
• MalfunctionJan 3, 2024Detachment 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 PERMANENT CAUTERY HOOK TIP WAS BROKEN. THERE WAS NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE CUSTOMER REPORTED THAT UNFORTUNATELY THEY DID NOT HAVE FURTHER INFO FOR THIS EVENT AND THAT ALL THAT THEY WERE AWARE OF WAS THAT THE ISSUE WAS NOTED PRIOR TO PROCEDURE DURING THE CASE CART CHECK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18433175 ↗
• MalfunctionDec 27, 2023Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE PERMANENT CAUTERY HOOK INSTRUMENT HAD A BROKEN STEEL WIRE. THE PROCEDURE WAS COMPLETED WITH NO REPORTS OF PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18396155 ↗