EndoWrist 470530Recalls & reported problems

Summary

The FDA's MAUDE database contains 136 adverse event reports that list this exact device (DI 00886874112717), received between Mar 7, 2017 and Sep 23, 2026 — classified as 2 deaths, 26 injuries, 108 malfunctions.

The most frequently reported specific device problem is “Difficult to Open or Close” (54 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 136 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 23, 2026Firing Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50875032 ↗
• MalfunctionMay 31, 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 25341546 ↗
• MalfunctionMay 9, 2026Break

  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 25131896 ↗
• MalfunctionApr 17, 2026No Device Output

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THERE WERE STAPLE REMNANTS LEFT IN THE TIP OF THE 8MM CURVED-TIP STAPLER INSTRUMENT. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: DURING THE USE OF THE STAPLER, IT WAS NOTED THAT IT APPEARED TO HAVE HAD SOME STAPLE REMNANTS WHILE TRYING TO INSERT A NEW STAPLE LOAD. THE DEVICE WAS NOT USED, AND A NEW ONE WAS USED IN PLACE OF THAT STAPLER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24917976 ↗
• MalfunctionMar 31, 2026Break

  REFER TO H11 FOR FOLLOW-UP INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24748290 ↗
• MalfunctionMar 3, 2026Break

  IT WAS REPORTED THAT THE CUSTOMER EXPERIENCED AN ISSUE WITH AN INTUITIVE PRODUCT. THE CUSTOMER REPORTED EVENT HAS NO REPORT OF PATIENT INJURY. INTUITIVE FOLLOWED UP WITH THE INITIAL REPORTER TO OBTAIN ADDITIONAL INFORMATION, HOWEVER, NO FURTHER DETAILS ARE AVAILABLE REGARDING THE REPORTED EVENT.

  Patient problems: Insufficient Information

  MAUDE report 24492953 ↗
• MalfunctionMar 2, 2026Material Split, Cut or Torn

  IT WAS REPORTED THAT THE CURVED-TIP STAPLER 30 HAD A FRAYED WIRE AND THE TIP DID NOT ROTATE. THERE WAS NO REPORTED HARM OR INJURY. ISI CONTACTED THE CUSTOMER FOR FOLLOW UP, HOWEVER THEY DID NOT HAVE ADDITIONAL INFORMATION TO PROVIDE ON THE REPORTED ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24478123 ↗
• MalfunctionFeb 27, 2026Difficult to Open or Close

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE ENDOWRIST 30 CURVED TIP STAPLER JAWS COULD NOT OPEN. THE USER WAS COMPLETING THE PROCEDURE AS PLANNED WITH NO FURTHER ISSUE REPORTED. NO FRAGMENT FELL INSIDE THE PATIENT. NO KNOWN IMPACT OR PATIENT CONSEQUENCE WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24471181 ↗
• MalfunctionFeb 26, 2026Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE CURVED-TIP 30 STAPLER INSTRUMENT HAD BROKEN CABLES. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24453825 ↗
• MalfunctionFeb 19, 2026Positioning Problem

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE CURVED-TIP STAPLER 30 INSTRUMENT RELOAD WOULD NOT SIT PROPERLY. THE PROCEDURE WAS COMPLETED WITH NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24385662 ↗
• MalfunctionJan 27, 2026Difficult to Open or Close

  REFER TO H11 FOR FOLLOW-UP INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24196225 ↗
• MalfunctionJan 27, 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 24194568 ↗
• MalfunctionJan 8, 2026Difficult to Open or Close

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE JAWS OF CURVED TIP STAPLER INSTRUMENT WOULD NOT OPEN. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24007398 ↗
• MalfunctionJan 6, 2026Unintended System Motion

  REFER TO H11 FOR FOLLOW-UP INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23983447 ↗
• MalfunctionJan 5, 2026Material Split, Cut or Torn

  REFER TO H11 FOR FOLLOW-UP INFORMATION.

  Patient problems: Insufficient Information

  MAUDE report 23969218 ↗
• MalfunctionDec 11, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING CENTRAL PROCESSING, CUSTOMER REPORTED A BROKEN WIRE. THERE WAS NO REPORT OF PATIENT INVOLVEMENT OR PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23784961 ↗
• MalfunctionNov 12, 2025Failure to Fire; Failure to Fire

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED PULMONARY LOBECTOMY SURGICAL PROCEDURE, CUSTOMER STATED FIRING FAILED, ERROR MESSAGE - CANNOT COMPLETE FIRING CYCLE. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23529848 ↗
• MalfunctionNov 12, 2025Unintended System Motion; Unintended System Motion

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED PULMONARY SEGMENTECTOMY SURGICAL PROCEDURE, THE WRIST PORTION OF THE STAPLER 30 CURVED-TIP INSTRUMENT WOULD NOT ARTICULATE APPROPRIATELY WHEN TRYING TO STAPLE. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23529783 ↗
• MalfunctionOct 15, 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: Insufficient Information

  MAUDE report 23305286 ↗
• MalfunctionSep 19, 2025No Apparent Adverse Event; No Apparent Adverse Event

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED PULMONARY LOBECTOMY SURGICAL PROCEDURE, THE ENDOWRIST 30 CURVED TIP STAPLER TIP HAD A ROTATION ISSUE. THE USER COMPLETED THE PROCEDURE WITH NO FURTHER ISSUE REPORTED. NO FRAGMENT FELL INSIDE THE PATIENT. NO KNOWN IMPACT OR PATIENT CONSEQUENCE WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23102144 ↗
• MalfunctionSep 19, 2025Firing Problem; Firing Problem

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED PULMONARY SEGMENTECTOMY SURGICAL PROCEDURE, THE 30 CURVED-TIP STAPLER INSTRUMENT GOT STUCK WHILE BEING USED SINCE IT HAD SUTURED AND CUT HALF THE LENGTH TO BE SUTURED. THERE WAS NO REPORT OF PATIENT HARM, ADVERSE OUTCOME, OR INJURY. INTUITIVE SURGICAL (IS) CONTACTED THE CUSTOMER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION REGARDING THIS EVENT: THE INSTRUMENT AND ACCESSORY WERE INSPECTED PRIOR TO USE, WITH NO DAMAGE OR ABNORMALITIES NOTED. THE INCIDENT INVOLVED A GREEN STAPLER RELOAD, CHOSEN FOR ITS CLINICAL SUITABILITY, DURING THE FIRST STAPLE FIRE IN A SEGMENTAL LUNG RESECTION TARGETING THE BRONCHUS. THE TISSUE WAS NEITHER CALCIFIED NOR HAD IT BEEN EXPOSED TO RADIATION OR CHEMOTHERAPY, AND THERE WAS NO TISSUE TENSION OR BUNCHING. THE ISSUE INVOLVED A PARTIAL FIRE, RESULTING IN AN EXPOSED BLADE AND MISSING STAPLES FROM THE STAPLE LINE, BUT NO MALFORMED STAPLES, GAPS, OR DEPLOYMENT OF STAPLES OCCURRED UNEXPECTEDLY. THERE WERE NO OBSTRUCTIONS OR PRIOR STAPLE LINES ENCOUNTERED, AND THE STAPLER DID NOT GET STUCK TO THE TISSUE. NO ERRORS OR MESSAGES WERE NOTED, AND THERE WAS NO BLEEDING, UNPLANNED TISSUE REMOVAL, OR FRAGMENTS DETACHE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23100724 ↗
• MalfunctionSep 19, 2025Firing Problem; Firing Problem

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED PULMONARY SEGMENTECTOMY SURGICAL PROCEDURE, THE CURVED-TIP 30 STAPLER INSTRUMENT GOT STUCK WHILE BEING USED SINCE IT HAD SUTURED AND CUT HALF THE LENGTH TO BE SUTURED. THE CUSTOMER REPLACED THE CURVED-TIP 30 STAPLER INSTRUMENT WITH A BACK-UP INSTRUMENT OF THE SAME KIND, WHICH ENCOUNTERED THE SAME PROBLEM, BUT THE SURGEON WAS ABLE TO COMPLETE THE STAPLING AND CUTTING WITH THIS INSTRUMENT. THERE WAS NO PATIENT HARM, ADVERSE OUTCOME, OR INJURY. INTUITIVE SURGICAL (IS) CONTACTED THE SITE AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION REGARDING THIS EVENT: THE INSTRUMENT WAS INSPECTED PRIOR TO USE WITH NO DAMAGE FOUND. THE REPORTED ISSUE INVOLVED A GREEN STAPLER RELOAD, SELECTED FOR ITS CLINICAL SUITABILITY, DURING THE FIRST STAPLER FIRE IN A SEGMENTAL LUNG RESECTION TARGETING THE BRONCHUS. THERE WAS NO CALCIFICATION, RADIATION, CHEMOTHERAPY EXPOSURE, TISSUE TENSION, OR BUNCHING. THE ISSUE WAS A PARTIAL FIRE, RESULTING IN AN EXPOSED BLADE AND MISSING STAPLES FROM THE STAPLE LINE, BUT NO MALFORMED STAPLES, UNEXPECTED STAPLE DEPLOYMENT, OR GAPS WERE OBSERVED. THE RELOAD WAS NOT STUCK TO TISSUE. THERE WERE NO OBSTRUCTIONS, PRIOR STAPLE LIN

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23100301 ↗
• MalfunctionSep 19, 2025Unintended System Motion; Unintended System Motion

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED TRANSTHORACIC CHEST ANASTOMOSIS ESOPHAGECTOMY SURGICAL PROCEDURE, THE ENDOWRIST 30 CURVED TIP STAPLER MOVED IN THE OPPOSITE OF THE INTENDED DIRECTION. THE USER COMPLETED THE PROCEDURE WITH NO FURTHER ISSUE REPORTED. NO KNOWN IMPACT OR PATIENT CONSEQUENCE WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23098263 ↗
• MalfunctionSep 19, 2025Difficult to Open or Close; Difficult to Open or Close

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED PULMONARY LOBECTOMY SURGICAL PROCEDURE, THE JAWS OF THE CURVED-TIP STAPLER 30 INSTRUMENT WOULD NOT OPEN. NO FRAGMENT FELL INTO THE PATIENT. THE CUSTOMER COMPLETED THE PROCEDURE AND NO KNOWN IMPACT OR PATIENT CONSEQUENCE WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23095819 ↗
• MalfunctionSep 16, 2025Material Frayed; Material Frayed

  IT WAS REPORTED THAT DURING CENTRAL PROCESSING, CUSTOMER IDENTIFIED A FRAYED CABLE NEAR TIP OF INSTRUMENT. THERE WAS NO REPORT OF PATIENT INVOLVEMENT OR PATIENT INJURY.

  Patient problems: Insufficient Information

  MAUDE report 23068933 ↗