EndoWrist 470298Recalls & reported problems

Summary

The FDA's MAUDE database contains 134 adverse event reports that list this exact device (DI 00886874112427), received between Apr 19, 2017 and Feb 26, 2026 — classified as 2 deaths, 26 injuries, 106 malfunctions.

The most frequently reported specific device problem is “Difficult to Open or Close” (79 reports).

1 FDA recall record name this device's identifier.

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. Sep 19, 2017Class IITerminated

   Specific da Vinci Xi EndoWrist Stapler 45 instruments are potentially impacted by a variation in the manufacturing process. In affected instruments, there is a possibility that the Stapler Release Kit (SRK) Wrench interface feature accessed through release hole 2 is manufactured to an incorrect dimension, which may prevent the SRK Wrench from being able to manually unclamp the instrument.

   Z-0404-2018 · Root cause: Process control · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 134 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 26, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING CENTRAL PROCESSING, THE 45 STAPLER INSTRUMENT HAD AN EXPOSED WIRE. THERE WAS NO REPORT OF PATIENT INVOLVEMENT OR PATIENT INJURY.

  Patient problems: Insufficient Information

  MAUDE report 24453415 ↗
• MalfunctionFeb 18, 2026Break

  IT WAS REPORTED THAT THE STAPLER 45 INSTRUMENT WAS BROKEN AND DID NOT WORK. NO KNOWN IMPACT OR PATIENT CONSEQUENCE WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24382548 ↗
• MalfunctionFeb 18, 2026Break

  IT WAS REPORTED THAT THE STAPLER 45 INSTRUMENT WAS BROKEN AND DID NOT WORK. NO KNOWN IMPACT OR PATIENT CONSEQUENCE WAS REPORTED. INTUITIVE FOLLOWED UP AND OBTAINED ADDITIONAL INFORMATION. THE OR TAGS THESE INSTRUMENTS AS BROKEN AND NEEDING TO BE REPLACED.

  Patient problems: Insufficient Information

  MAUDE report 24382391 ↗
• MalfunctionFeb 13, 2026Break

  IT WAS REPORTED THAT THE STAPLER 45 INSTRUMENT WAS BROKEN, DID NOT WORK. NO KNOWN IMPACT OR PATIENT CONSEQUENCE WAS REPORTED. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED ADDITIONAL INFORMATION: THE HOSPITAL TAGGED THESE INSTRUMENTS AS BROKEN AND NEEDING TO BE REPLACED. NO MORE INFORMATION AVAILABLE AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24339016 ↗
• MalfunctionJan 27, 2026Difficult to Open or Close

  REFER TO H11 FOR FOLLOW-UP INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24196014 ↗
• MalfunctionOct 31, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  REFER TO H11 FOR FOLLOW-UP INFORMATION.

  Patient problems: Insufficient Information

  MAUDE report 23442576 ↗
• MalfunctionOct 22, 2025Grounding Malfunction; Product Quality Problem; Therapeutic or Diagnostic Output Failure

  THE DA VINCI XI ROBOT [REDACTED] MALFUNCTIONED 8 TIMES DURING THE CASE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23356190 ↗
• MalfunctionJul 28, 2025No Apparent Adverse Event; No Apparent Adverse Event

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE ENDOWRIST 45 STAPLER STOPPED WORKING PROPERLY. THE USER COMPLETED THE PROCEDURE WITH NO FURTHER ISSUE REPORTED. NO FRAGMENT FELL INSIDE THE PATIENT. NO KNOWN IMPACT OR PATIENT CONSEQUENCE WAS REPORTED. ISI FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE JAWS OF THE STAPLER WERE NOT WORKING PROPERLY WHICH CAUSED THE DEVICE TO MALFUNCTION WHICH RESULTED IN THE STAPLERS NOT FIRING. THE STAPLING ISSUE DID NOT CAUSE THE RELOAD TO BECOME STUCK ON TISSUE, NOR WERE THERE ANY STAPLED MISSING FROM THE STAPLE LINE OR HOLES OR GAPS OBSERVED WITHIN THE STAPLE LINE. THE ISSUE WAS RESOLVED BY UTILIZING A BACKUP STAPLER. THERE WAS NO BLEEDING OBSERVED ON THE STAPLE LINE DUE TO THE REPORTED STAPLER ISSUE. THE BLEEDING OBSERVED WAS NORMAL AND EXPECTED AS PART OF THE PROCEDURE. THERE WAS NO UNPLANNED TISSUE REMOVAL. PATIENT DEMOGRAPHIC INFORMATION WAS NOT PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22637535 ↗
• MalfunctionMar 5, 2025Break; Break

  IT WAS REPORTED THAT DURING CENTRAL PROCESSING, THE STAPLER 45 HAD A BROKEN END. THERE WAS NO REPORT OF PATIENT INVOLVEMENT.

  Patient problems: Insufficient Information

  MAUDE report 21522394 ↗
• MalfunctionJan 11, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING CENTRAL PROCESSING, THE CABLE WAS BROKEN ON THE STAPLER 45 INSTRUMENT. THE PROCEDURE WAS COMPLETED WITH NO REPORT OF PATIENT INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE TECHNICIANS WERE TRAINED TO DO A QUICK LOOK BEFORE INSERTION TO LOOK FOR ANYTHING OUT OF THE ORDINARY. EVERYTHING ON THE INSTRUMENT APPEARED TO BE INTACT. IT WASN¿T UNTIL THE INSTRUMENT WAS ACTUALLY IN THE INITIAL MOTIONS THAT THE CABLE WAS DISCOVERED BECAUSE THE INSTRUMENT WOULD NOT MOVE PROPERLY WHEN TESTED BY THE SURGEON (THEY ALWAYS TEST THE MOTION AFTER INITIAL INSERTION TO BE SURE IT IS ALL WORKING, WHICH THIS WAS NOT). THE STAFF REMOVED THE INSTRUMENT AND DISCOVERED THE CABLE WAS DAMAGED. THE INSTRUMENT NEVER WORKED. AFTER INITIAL INSERTION, IT DID NOT MOTION PROPERLY SO IT WAS REMOVED AND INSPECTED, DISCOVERING THE CABLE. THE INSTRUMENT DID NOT COLLIDE WITH ANY OTHER INSTRUMENTS DURING THE PROCEDURE. NO FRAGMENTS FELL INSIDE THE PATIENT'S ANATOMY. THE INSTRUMENT WAS SENT TO ISI FOR ANALYSIS. NO PHOTOS OR VIDEOS ARE AVAILABLE FOR REVIEW.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18490517 ↗
• MalfunctionSep 18, 2023Firing Problem; Firing Problem

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED WEDGE-TO-COMPLETION LOBECTOMY SURGICAL PROCEDURE, THE STAPLER 45 INSTRUMENT FAILED TO DEPLOY. THE PROCEDURE WAS COMPLETED AS PLANNED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE CUSTOMER DID NOT HAVE ADDITIONAL INFORMATION TO PROVIDE ON THE REPORTED ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17765287 ↗
• MalfunctionJul 12, 2023Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED CENTRAL PROCESSING, THE STAPLER 45 INSTRUMENT WAS NOTED WITH A GOLD PIN BROKEN OFF ON THE CASING. THERE WAS NO REPORT OF PATIENT INVOLVEMENT OR NO REPORTED INJURY.

  Patient problems: Insufficient Information

  MAUDE report 17313040 ↗
• MalfunctionJun 8, 2023Difficult to Open or Close; Difficult to Open or Close

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE STAPLER 45 INSTRUMENT WAS JAMMED AND COULD NO LONGER BE OPENED. THE STAPLER RELEASE KIT WAS USED TO REMOVE THE INSTRUMENT. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17093856 ↗
• MalfunctionJun 8, 2023Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT DURING A DA VINCI ASSISTED LOW ANTERIOR RESECTION PROCEDURE, THE STAPLER 45 INSTRUMENT FAILED TO UNCLAMP. THE PROCEDURE WAS COMPLETED WITHOUT REPORTED INJURY. ISI FOLLOWED UP WITH THE INITIAL REPORTER AND ON 1/20/2022, OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE STAPLER RELEASE KIT WAS USED TO OPEN THE JAWS OF THE STAPLER. THERE WAS NO HARM TO THE PATIENT. THE PROCEDURE CONTINUED AS PLANNED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17093855 ↗
• MalfunctionJun 6, 2023Visual Prompts will not Clear; Failure to Form Staple; Visual Prompts will not Clear; Failure to Form Staple

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED DONOR HEPATECTOMY SURGICAL PROCEDURE, THE STAPLER 45 INSTRUMENT EXPERIENCED AN ERROR DURING STAPLE FIRING - MISFIRE AND BLADE EXPOSED MESSAGE. THE CUSTOMER USED A THIRD-PARTY HANDHELD STAPLER TO COMPLETE PROCEDURE, WHICH WAS CONVERTED TO LAPAROSCOPIC SURGERY WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: DURING A RIGHT HEPATECTOMY, THE STAPLER MISFIRED, GIVING AN ERROR MESSAGE - "STAPLER MISFIRE, BLADE MAY BE EXPOSED". THE STAPLER ACHIEVED 100% CLAMP ALLOWING THE SURGEON TO FIRE THE STAPLER, BUT WHEN CUTTING THE TISSUE, THE STAPLER DID NOT COMPLETE THE CUT AND TRIGGERED AN ERROR, LEAVING THE BLADE EXPOSED. AS THE HEPATECTOMY WAS BEING DONE FOR HEPATOCELLULAR CARCINOMA, WIDE MARGINS WERE BEING DONE TO ALLOW FOR COMPLETE EXCISION OF THE TUMOR, SO THE STAPLER WAS CUTTING THROUGH NORMAL LIVER TISSUE. THE PATIENT HAD Y90 RADIOEMBOLIZATION OF 2 HEPATOMAS, BUT THE ISSUE OCCURRED WHEN THE SURGEON WAS CUTTING THROUGH NORMAL LIVER TISSUE. THE SURGEON DID NOT ENCOUNTER ANY OBSTRUCTIONS SUCH AS CLIPS, STAPLES, BONE, OR OTHER HARD OBJECTS BETWEEN THE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17067488 ↗
• MalfunctionJun 5, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  THE STAPLER 45 INSTRUMENT WAS RETURNED WITH NO REPORTED COMPLAINT. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE CUSTOMER TO REQUEST INFORMATION ON WHY THE INSTRUMENT WAS RETURNED, BUT NO INFORMATION WAS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17067459 ↗
• MalfunctionJun 2, 2023Fracture; Fracture

  THE STAPLER 45 INSTRUMENT WAS RETURNED WITH NO ALLEGED COMPLAINT. NO ALLEGATION WAS MADE AGAINST THIS PRODUCT. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) MADE MULTIPLE FOLLOW-UP ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION. HOWEVER, NO FURTHER DETAILS HAVE BEEN RECEIVED AS OF THE DATE OF THIS REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17045894 ↗
• InjuryJun 1, 2023Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED GASTRIC BYPASS (GB) SURGICAL PROCEDURE, THE STAPLER 45 INSTRUMENT FIRED A GREEN RELOAD ACCESSORY WITHOUT ANY ISSUE(S) DURING THE FIRST FIRING. ON THE SECOND FIRE, WITH ANOTHER GREEN RELOAD, ONLY A STAPLE LINE WAS FORMED WITHOUT A CUT. THE SURGEON ATTEMPTED A THIRD GREEN RELOAD, AND ONLY A STAPLER LINE WAS FORMED WITHOUT A CUT AGAIN. THE CUSTOMER USED A SECOND STAPLER 45 INSTRUMENT, AND THE SURGEON FIRED A GREEN RELOAD ACCESSORY WITHOUT ISSUE, DURING THE FIRST FIRING. ON THE SECOND FIRE, WITH ANOTHER GREEN RELOAD, THE STAPLER INSTRUMENT STOPPED HALFWAY, WITH THE MESSAGE: "UNABLE TO COMPLETE FIRE. TAP BLUE PEDAL TO UNCLAMP THEN REMOVE STAPLER. WARNING: BLADE MAY BE EXPOSED." IT WAS FOUND THAT THE STAPLE LINE WAS HALFWAY THROUGH, WITH AN IRREGULAR STAPLE LINE. THE SURGEON STOPPED THE BLEEDING WITH ROBOTIC BIPOLAR AND HARMONIC INSTRUMENTS. THE CUSTOMER REMOVED THE SECOND STAPLER INSTRUMENT AND USED A THIRD, BACKUP STAPLER 45 INSTRUMENT. THE THIRD STAPLER INSTRUMENT WORKED FINE FOR FIRING; HOWEVER, WHEN THE CUSTOMER ATTEMPTED TO REMOVE THE INSTRUMENT, IT WAS STUCK TO THE STERILE ADAPTER (SA). THE CUSTOMER PRESSED THE EMERGENCY STOP BUTTON

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17038005 ↗
• MalfunctionMay 28, 2023Failure to Fire; Failure to Fire

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, ENDOWRIST STAPLER 45 HAD FIRING ISSUE. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) MADE MULTIPLE FOLLOW UP ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION. HOWEVER, NO FURTHER DETAILS HAVE BEEN RECEIVED AS OF THE DATE OF THIS REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17016022 ↗
• MalfunctionMay 28, 2023Material Integrity Problem; Material Split, Cut or Torn; Material Integrity Problem; Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING CENTRAL PROCESSING, SCRATCHES WERE NOTED ON THE STAPLER 45 INSTRUMENT CABLE. THE INSIDE COATING OF THE CABLE WAS EXPOSED. THERE WAS NO REPORT OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17015903 ↗
• MalfunctionMay 28, 2023Difficult to Open or Close; Difficult to Open or Close

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE ENDOWRIST STAPLER 45 INSTRUMENT CLAMPED ON TISSUE, BUT IT WOULD NOT FIRE AND THE JAWS DID NOT OPEN. THE CUSTOMER USED A STAPLER RELEASE KIT (SRK) TO OPEN THE STAPLER 45 INSTRUMENT JAWS AND REMOVE IT FROM TISSUE. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) MADE MULTIPLE FOLLOW-UP ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION. HOWEVER, NO FURTHER DETAILS HAVE BEEN RECEIVED AS OF THE DATE OF THIS REPORT. THIS COMPLAINT WILL BE CLASSIFIED BASED ON THE PROVIDED INFORMATION AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17015899 ↗
• MalfunctionMay 28, 2023Failure to Fire; Failure to Fire

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED UROLOGY SURGICAL PROCEDURE, THE STAPLER 45 DID NOT FIRE. 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 PROCEDURE WAS COMPLETED AS PLANNED WITH NO REPORT OF PATIENT INJURY. THE ISSUE WAS RESOLVED BY USING ANOTHER DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17015896 ↗
• MalfunctionMay 27, 2023Material Frayed; Material Frayed

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED COLOSTOMY CLOSURE SURGICAL PROCEDURE, A WIRE WAS STICKING OUT OF THE STAPLER 45. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17015752 ↗
• MalfunctionMay 27, 2023Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED LOW ANTERIOR RESECTION SURGICAL PROCEDURE, ONE OF THE WIRES WAS SLIGHTLY STICKING OUT AND THE STAPLER 45 WOULD NOT ENGAGE. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17015751 ↗
• InjuryMay 13, 2023Detachment of Device or Device Component; Difficult to Open or Close; Detachment of Device or Device Component; Difficult to Open or Close

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED LOW ANTERIOR RESECTION SURGICAL PROCEDURE, THE STAPLER 45 INSTRUMENT SUCCESSFULLY FIRED AND TRANSECTED DURING ITS FIRST USE (1ST STAPLE FIRE). ON THE 2ND INTENDED FIRE (THE INSTRUMENT WAS INSTALLED WITH A BLUE STAPLER RELOAD) THE INSTRUMENT TIP WAS UNABLE TO OPEN WHILE INSIDE THE ABDOMINAL CAVITY. THE INSTRUMENT WAS REMOVED AND REINSTALLED, BUT THE ISSUE PERSISTED. FOLLOWING THIS, THE INSTRUMENT WAS REPLACED TO THE BACKUP INSTRUMENT. INSPECTION OF THE ABDOMINAL CAVITY IDENTIFIED A PIECE OF WIRE. THE ENTIRE PIECE WAS REMOVED OUT OF THE PATIENT. THE SURGEON COMPLETED THE SURGICAL TASK USING THE BACKUP INSTRUMENT. AN X-RAY WAS PERFORMED AND CONFIRMED NO ADDITIONAL FRAGMENTS WERE LEFT INSIDE THE PATIENT. THE USER COMPLETED THE PROCEDURE WITH NO FURTHER ISSUE REPORTED. NO KNOWN IMPACT OR PATIENT CONSEQUENCE WAS REPORTED. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE SITE AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT: THE ISI CLINICAL SALES REPRESENTATIVE (CSR) COMMUNICATED THAT THE SITE REPORTED THAT THEY DID NOT INSTALL A STAPLER SHEATH ON THE INSTRUMENT DURING INTRAOPERATIVE USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16927521 ↗