EndoWrist;daVinci Si 410298Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 00886874111093), received between Feb 3, 2017 and Jun 5, 2023 — classified as 8 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Difficult to Open or Close” (6 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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 5, 2023Retraction Problem; Retraction Problem

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, A STAPLER 45 INSTRUMENT HAD A BLADE EXPOSED ERROR DURING FIRING AND CUTTING IN HALF. THE CUSTOMER WAS ABLE TO OPEN THE GRIP USING A STAPLER RELEASE KIT (SRK) AND REMOVED THE INSTRUMENT. THE CUSTOMER USED A THIRD-PARTY LAPAROSCOPIC STAPLER TO CONTINUE AND CONVERTED THE PROCEDURE TO LAPAROSCOPIC SURGERY WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE OR NURSE AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE PROCEDURE WAS CONVERTED TO LAPAROSCOPIC SURGERY BECAUSE A BACKUP INSTRUMENT WAS NOT AVAILABLE. THERE WAS NO INJURY TO THE PATIENT. THE INSTRUMENT WAS INSPECTED PRIOR TO USE. AFTER ATTEMPTING TO ENGAGE THE INSTRUMENT FOR 5-6 TIMES, CALIBRATION AND INITIALIZATION PASSED AND CLAMPING AND CUTTING WERE PERFORMED. DURING THE STAPLER CLAMPING SEQUENCE, THE CLAMPING TIME AT LEAST 45 SECONDS-1 MINUTE IS JUDGED TO HAVE PASSED SINCE THE UNCLAMPING WAS PERFORMED 3 TIMES UNTIL THE SMART CLAMPING WAS COMPLETED ACCORDING TO THE THICKNESS. THE SURGEON DID NOT RECEIVE AN UNCLAMP FAILURE FOLLOWING AN ABORTED CLAMP ATTEMPT. AFTER CLAMPING WAS COMPLETED, A 'BLADE MAY BE EXPOSED' ERROR OCCURRED DURIN

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17067485 ↗
• InjuryMay 30, 2023Failure to Fire; Failure to Fire

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED HEMICOLECTOMY (LEFT) SURGICAL PROCEDURE, THE ENDOWRIST STAPLER 45 FIRED TWICE AND THEN STOPPED WORKING. THE PROCEDURE WAS CONVERTED TO OPEN. 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 17028363 ↗
• MalfunctionDec 2, 2020Difficult to Open or Close; Mechanical Jam; Difficult to Open or Close; Mechanical Jam

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED LOW ANTERIOR RESECTION SURGICAL PROCEDURE, WHEN THE CUSTOMER TRIED TO RESECT WITH THE STAPLER 45 BLUE CARTRIDGE, A "YELLOW ERROR" OCCURRED AND THE STAPLER 45 INSTRUMENT GOT STUCK WITH THE TISSUE "BITTEN." IT WAS REPORTED THAT A MESSAGE PROMPTING THE USER TO USE THE RELEASE KIT WAS BEING DISPLAYED SO THE CUSTOMER FOLLOWED THE INSTRUCTIONS TO USE THE RELEASE KIT. THE CUSTOMER STATED THAT ANOTHER INSTRUMENT WAS INSTALLED AND FIRED TO COMPLETE THE PROCEDURE. THE SURGEON ACKNOWLEDGED THAT THE USE OF THE BLUE RELOAD MAY HAVE NOT BEEN APPROPRIATE SINCE MULTIPLE CLAMPS WERE REQUIRED. THE PROCEDURE WAS COMPLETED AS PLANNED WITH NO ADDITIONAL ISSUES. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE INSTRUMENT WAS INSPECTED PRIOR TO USE AND NO ABNORMALITIES WERE NOTED. THE SURGEON DID NOT ENCOUNTER ANY OBSTRUCTIONS SUCH AS CLIPS, STAPLES, OR OTHER HARD MATERIAL BETWEEN THE INSTRUMENT JAWS, BUT THE SURGEON HAD TO CLAMP FOUR OR FIVE TIMES FOR THE INSTRUMENT TO FIRE. THE CUSTOMER ACKNOWLEDGED THAT TISSUE THICKNESS MAY HAVE BEEN INAPPROPRIATE FOR THE BLUE RELOAD. THE USE OF T

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10933582 ↗
• MalfunctionDec 1, 2020Difficult to Open or Close; Mechanical Jam; Difficult to Open or Close; Mechanical Jam

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE STAPLER 45 INSTRUMENT WOULD NOT FIRE PROPERLY. THE STAPLER 45 INSTRUMENT REPORTEDLY "MADE A WEIRD NOISE DURING CALIBRATION OF THE THIRD FIRING SEQUENCE." AN ERROR MESSAGE OCCURRED STATING "FAILURE TO UNCLAMP." THE STAPLER 45 INSTRUMENT WAS ABLE TO COMPLETE 2 FIRES PRIOR TO THE ISSUE. THE CUSTOMER USED A STAPLER RELEASE KIT (SRK) TO RELEASE THE STAPLER 45 INSTRUMENT. THE CUSTOMER REPLACED THE STAPLER 45 INSTRUMENT WITH A BACKUP INSTRUMENT OF THE SAME KIND AND CONTINUED WITH THE CASE. THE PROCEDURE WAS COMPLETED WITH NO REPORT OF PATIENT HARM, INJURY OR ADVERSE OUTCOME. INTUITIVE SURGICAL, INC. (ISI) OBTAINED THE FOLLOWING ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT: THE PROCEDURE WAS A ROBOTIC LUNG THORACOSCOPY WITH DECORTICATION AND BIOPSY. THE CUSTOMER REPORTED THE STAPLER 45 INSTRUMENT WAS GRASPING ON TISSUE WHEN THE ISSUE OCCURRED; HOWEVER, THERE WAS NO PATIENT HARM. THERE WAS NO PARTIAL FIRE. THE TARGET TISSUE WAS THE RIGHT LUNG LOWER LOBE. THE PATIENT HAD NOT UNDERGONE ANY PREVIOUS CHEMOTHERAPY OR RADIATION TREATMENTS. THE INTEGRITY OF THE PATIENT'S TISSUE WAS GOOD. THE SURGEON DID NOT ENCOUNTER AN

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10925903 ↗
• MalfunctionSep 29, 2020Break; Difficult to Open or Close; Break; Difficult to Open or Close

  IT WAS REPORTED DURING A DA VINCI-ASSISTED PROCEDURE THE STAPLER 45 INSTRUMENT LOCKED UP. A BLUE STAPLER 45 RELOAD WAS INSTALLED ON IT. THE SITE WAS ABLE TO SUCCESSFULLY USE THE STAPLER RELEASE KEY (SRK) TO OPEN THE INSTRUMENT¿S JAWS. THE PROCEDURE WAS COMPLETED WITH A BACKUP ENDOGIA LAPAROSCOPIC INSTRUMENT, AND THERE WAS NO REPORTED PATIENT HARM, INJURY, OR ADVERSE OUTCOME. ON 11-SEPT-2020, INTUITIVE SURGICAL, INC. (ISI), CONTACTED THE SURGEON, AND OBTAINED THE FOLLOWING INFORMATION: THE SURGEON HAD STATED THAT HE HAD TWO ISSUES WITH STAPLER. TISSUE WAS THICK AND STAPLER HAD PROBLEMS CLAMPING DOWN COMPLETELY. IT TOOK MORE THAN 10 MINUTES TO FINALLY FIRE THE FIRST TIME. THE FIRST ERROR OCCURRED DURING ONE OF THE UNCLAMPING SEQUENCES WHERE AN ERROR MESSAGE STATED BLADE WAS EXPOSED, AND THE RELOAD WAS REPLACED. THE SURGEON STATED THAT HE WAS ABLE TO FIRE THE STAPLER WITH THE RELOAD. HOWEVER, HE STATED THAT HE WAS UNABLE TO COMPLETELY TRANSECT THE BOWEL AND, AS A RESULT, USED ANOTHER RELOAD. AT THAT TIME, THE SECOND ERROR OCCURRED. AS A RESULT, THE STAPLER RELEASE KEY WAS USED TO REMOVE THE STAPLER. THE SURGEON CONFIRMED THAT THE PROCEDURE WAS COMPLETED WITH AN ENDOGIA LAPAROSCOPIC ST

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10598503 ↗
• InjuryApr 3, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.

  Patient problems: Hemorrhage, Cerebral

  MAUDE report 9925273 ↗
• MalfunctionNov 20, 2019Output Problem

  DURING ROBOTIC SURGERY, THE STAPLER WAS PLACED IN THE ROBOTIC ARM AND IT DID NOT WORK. AFTER ABOUT 15 MINUTES OF TROUBLE SHOOTING, IT WAS DETERMINED THAT THE MOTOR PACK OF THE STAPLER DEVICE (REUSABLE FOR 45 USES) DID NOT WORK. A REPLACEMENT MOTOR PACK WAS OPENED AND PROCEDURE COMMENCED WITHOUT FURTHER ISSUE. INTUITIVE SURGICAL NOTIFIED AND CONSULTED DURING TROUBLESHOOTING.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9347586 ↗
• MalfunctionApr 22, 2019Defective Component; Physical Resistance/Sticking

  THE DAVINCI STAPLER WOULD NOT RELEASE FROM THE INSTRUMENT ARM WHILE IN THE PATIENT. EVENTUALLY, THE ENTIRE PORT, STAPLER, AND INSTRUMENT ARM WERE REMOVED FROM USE. ONCE THE ARM WAS DISENGAGED, THE DEFECTIVE STAPLER WAS ABLE TO BE REMOVED FROM THE INSTRUMENT ARM. NO HARM TO THE PATIENT. THE DAVINCI ONLINE SUPPORT WAS CALLED TO HELP TROUBLE SHOOT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8535269 ↗
• InjuryMay 31, 2018Device Issue; Device Issue

  IT WAS INITIALLY REPORTED THAT DURING A DA VINCI-ASSISTED ILEAL CONDUIT PROCEDURE, THE STAPLER 45 INSTRUMENT ALLEGEDLY HAD A PARTIAL FIRE ISSUE AND THE STAPLER BLADE WAS FOUND TO BE OFF THE TRACK. AS A RESULT OF THE EVENT, THE INITIAL REPORTER CLAIMED THAT THE ILEAL CONDUIT WAS DAMAGED. ON (B)(6) 2018, INTUITIVE SURGICAL, INC. (ISI) CONTACTED THE ISI CLINICAL SALES REPRESENTATIVE (CSR) AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT: THE REPORTED EVENT OCCURRED DURING THE 4TH OR 5TH FIRE OF THE STAPLER 45 INSTRUMENT. A BLUE STAPLER 45 RELOAD WAS INSTALLED AT THE TIME. THERE WERE NO REPORTED ERROR MESSAGES WHEN THE EVENT OCCURRED. THE SURGEON DID NOT ENCOUNTER ANY CLAMPING ISSUES PRIOR TO FIRING THE INSTRUMENT. ACCORDING TO THE CSR, THE STAPLE LINES LOOKED COMPLETE; HOWEVER, IT DID NOT APPEAR AS THOUGH THE BLADE OF THE STAPLER RELOAD HAD CUT. THE CSR INDICATED THAT THERE WAS A HOLE AROUND THE STAPLE LINE BUT SHE WAS NOT SURE IF THE HOLE WAS CREATED BEFORE OR DURING THE TIME THE STAPLER 45 INSTRUMENT WAS FIRED. THE CSR INDICATED THAT THE SURGEON OVER-SEWED THE STAPLE LINES AS A PRECAUTION DUE TO THE CUSTOMER REPORTED STAPLING ISSUE. TO HER KNOWLEDGE, TH

  Patient problems: Failure to Anastomose

  MAUDE report 7557064 ↗
• InjurySep 15, 2017Difficult to Open or Close; Difficult to Open or Close

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SIGMOID COLECTOMY PROCEDURE, THE JAWS OF THE ENDOWRIST STAPLER 45 INSTRUMENT GOT STUCK ON TISSUE AND COULD NOT BE REMOVED. THE INITIAL REPORTER AND AN OR STAFF MEMBER CONTACTED AN INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) FOR ASSISTANCE DURING THE EVENT. THE OR STAFF MEMBER INDICATED THAT SHE HAD ATTEMPTED UNSUCCESSFULLY TO OPEN THE JAWS OF THE ENDOWRIST STAPLER 45 INSTRUMENT USING AN INSTRUMENT RELEASE KIT (IRK) TOOL. AT THAT TIME, THE OR STAFF HAD REMOVED THE STAPLER MOTOR PACK (SMP). DURING TROUBLESHOOTING, THE TSE INSTRUCTED THE OR STAFF MEMBER TO FIND A STAPLER RELEASE KIT (SRK). HOWEVER, BY THE TIME THE OR STAFF MEMBER FOUND A SRK, THE SURGEON HAD ALREADY MOVED FORWARD BY USING AN ALTERNATIVE SURGICAL INTERVENTION TO REMOVE THE STUCK ENDOWRIST STAPLER 45 INSTRUMENT. THE OR STAFF MEMBER EXPLAINED THAT THE ENDOWRIST STAPLER 45 INSTRUMENT WAS SUCCESSFULLY REMOVED FROM THE PATIENT SIDE MANIPULATOR (PSM) BUT TISSUE WAS STILL STUCK BETWEEN THE INSTRUMENT'S JAWS. THE TSE WALKED THE OR STAFF MEMBER THROUGH SEVERAL UNSUCCESSFUL ATTEMPTS TO OPEN THE JAWS OF THE ENDOWRIST STAPLER 45 INSTRUMENT WITH THE SRK. THE OR STA

  Patient problems: Tissue Damage

  MAUDE report 6871187 ↗
• InjuryMay 15, 2017Mechanical Problem; Misfire; Human-Device Interface Problem; Adverse Event Without Identified Device or Use Problem; Mechanical Problem; Misfire; Human-Device Interface Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE DURING A DA VINCI-ASSISTED LOW ANTERIOR RESECTION (LAR) PROCEDURE, THE STAPLER 45 INSTRUMENT MISFIRED. ON 04-26-2017 AND 05-05-2017, INTUITIVE SURGICAL, INC. (ISI) RECEIVED ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT FROM THE ISI CLINICAL SALES REPRESENTATIVE WHO WAS PRESENT FOR THE SURGICAL PROCEDURE. ACCORDING TO THE CSR, THE SURGEON WAS ATTEMPTING TO TRANSECT COLON TISSUE USING THE STAPLER 45 INSTRUMENT WITH A GREEN STAPLER 45 RELOAD INSTALLED WHEN THE ERROR MESSAGE PARTIAL FIRE-BLADE EXPOSED WAS GENERATED. THE CSR INDICATED THAT THE MISFIRE ISSUE OCCURRED DURING THE SECOND FIRING SEQUENCE FROM THE INSTRUMENT DURING THE SURGICAL PROCEDURE. THE CLINICAL STAFF INSTALLED A REPLACEMENT STAPLER 45 INSTRUMENT AND GREEN STAPLER 45 RELOAD, HOWEVER, THE ISSUE RECURRED. THE SITE DID NOT HAVE A REPLACEMENT INSTRUMENT TO COMPLETE THE PROCEDURE ROBOTICALLY, THUS THE SURGEON MADE THE DECISION TO COMPLETE THE PLANNED SURGICAL PROCEDURE USING EXTRA-CORPOREAL TECHNIQUES. THE PATIENT WAS DISCHARGED HOME AND WAS REPORTED TO BE DOING WELL. MFR REPORT 2955842-2017-00302 HAS BEEN SUBMITTED REGARDING THE FIRST STAPLER 45 INSTRUMENT.

  Patient problems: Injury

  MAUDE report 6567149 ↗
• InjuryMay 15, 2017Mechanical Problem; Misfire; Human-Device Interface Problem; Adverse Event Without Identified Device or Use Problem; Mechanical Problem; Misfire; Human-Device Interface Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE DURING A DA VINCI-ASSISTED LOW ANTERIOR RESECTION (LAR) PROCEDURE, THE STAPLER 45 INSTRUMENT MISFIRED. ON 04-26-2017 AND 05-05-2017, INTUITIVE SURGICAL, INC. (ISI) RECEIVED ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT FROM THE ISI CLINICAL SALES REPRESENTATIVE WHO WAS PRESENT FOR THE SURGICAL PROCEDURE. ACCORDING TO THE CSR, THE SURGEON WAS ATTEMPTING TO TRANSECT COLON TISSUE USING THE STAPLER 45 INSTRUMENT WITH A GREEN STAPLER 45 RELOAD INSTALLED WHEN THE ERROR MESSAGE PARTIAL FIRE-BLADE EXPOSED WAS GENERATED. THE CSR INDICATED THAT THE MISFIRE ISSUE OCCURRED DURING THE SECOND FIRING SEQUENCE FROM THE INSTRUMENT DURING THE SURGICAL PROCEDURE. THE CLINICAL STAFF INSTALLED A REPLACEMENT STAPLER 45 INSTRUMENT AND GREEN STAPLER 45 RELOAD, HOWEVER, THE ISSUE RECURRED. THE SITE DID NOT HAVE A REPLACEMENT INSTRUMENT TO COMPLETE THE PROCEDURE ROBOTICALLY, THUS THE SURGEON MADE THE DECISION TO COMPLETE THE PLANNED SURGICAL PROCEDURE USING EXTRA-CORPOREAL TECHNIQUES. THE PATIENT WAS DISCHARGED HOME AND WAS REPORTED TO BE DOING WELL. MFR REPORT 2955842-2017-00301 HAS BEEN SUBMITTED REGARDING THE SECOND STAPLER 45 INSTRUMENT.

  Patient problems: Injury

  MAUDE report 6567142 ↗
• InjuryFeb 17, 2017Difficult to Open or Close; Difficult to Open or Close

  IT WAS INITIALLY REPORTED THAT DURING A DA VINCI-ASSISTED GASTRIC BYPASS PROCEDURE, THE JAWS OF THE STAPLER 45 INSTRUMENT LOCKED AND COULD NOT BE OPENED. THE SURGICAL STAFF WAS ABLE TO REMOVE THE INSTRUMENT BY USING THE STAPLER RELEASE KIT (SRK). THERE WERE NO REPORTS OF ANY PATIENT INJURY. IN RELATION TO THE REPORTED EVENT, INTUITIVE SURGICAL, INC. (ISI) RECEIVED FDA VOLUNTARY REPORT MW5067052 ON 01/27/2017 WITH THE FOLLOWING EVENT DESCRIPTION: DURING A ROBOTIC ASSISTED LAPAROSCOPIC GASTRECTOMY SLEEVE, THE DA VINCI STAPLER WAS BEING USED WHEN IT ALERTED AN ERROR ON THE MONITORING SYSTEM AND LOCKED THE STAPLER. THE STAPLER RELEASE KEY WAS USED TO REMOVE THE TISSUE FROM THE STAPLER AND TO REMOVE THE STAPLER FROM THE LAPAROSCOPIC PORT IN THE ABDOMEN. THE STAPLE LINE ON THE STOMACH WAS REINFORCED WITH SUTURES. INTUITIVE REP IN OPERATING ROOM WHEN ISSUE WITH STAPLER OCCURRED. ON 01/30/2017, ISI CONTACTED THE ISI CLINICAL SALES REPRESENTATIVE (CSR) AND OBTAINED THE FOLLOWING INFORMATION REGARDING THE REPORTED EVENT: THE CSR CONFIRMED THAT WHEN THE ERRORS OCCURRED, THE STAPLER 45 INSTRUMENT LOCKED UP AND HAD TO BE REMOVED WITH THE SRK. AT THAT POINT, THE SURGEON DID NOT KNOW IF THE STAPL

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6339048 ↗
• InjuryFeb 3, 2017Difficult to Open or Close; Difficult to Open or Close

  IT WAS INITIALLY REPORTED THAT DURING A DA VINCI-ASSISTED COLON RESECTION PROCEDURE, THE SURGEON WAS UNABLE TO OPEN THE JAWS OF THE STAPLER 45 INSTRUMENT WHICH WAS CLAMPED DOWN ON TISSUE. PRIOR TO CALLING AN INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) FOR ASSISTANCE, THE SURGICAL STAFF TRIED TO OPEN THE JAWS OF THE INSTRUMENT USING A STAPLER RELEASE KIT (SRK). AT THAT TIME, THE SURGICAL STAFF DID NOT PRESS THE EMERGENCY STOP (E-STOP) BUTTON. AFTER CONTACTING THE TSE, THE TSE INSTRUCTED THE SURGICAL STAFF WITH PRESSING THE E-STOP FIRST PRIOR TO ATTEMPTING TO USE THE SRK. EVEN THROUGH TROUBLESHOOTING, THE SURGICAL STAFF STILL COULD NOT REMOVE THE STAPLER 45 INSTRUMENT. THE SURGICAL PROCEDURE WAS CONVERTED TO HAND-ASSISTED LAPAROSCOPIC SURGERY. ISI CONTACTED THE SITE'S ROBOTICS COORDINATOR AND OBTAINED THE FOLLOWING INFORMATION REGARDING THE REPORTED EVENT: THE SURGEON WAS IN THE PROCESS OF FIRING THE FIRST STAPLER 45 RELOAD WITH THE STAPLER 45 INSTRUMENT WHEN THE EVENT OCCURRED. THE SURGEON DID NOT ENCOUNTER ANY OBSTRUCTIONS DURING THE PROCESS OF CLAMPING THE STAPLER 45 INSTRUMENT DOWN ON BOWEL TISSUE. ACCORDING TO THE ROBOTICS COORDINATOR, THE STAPLER 45 INSTRUME

  Patient problems: Injury

  MAUDE report 6302113 ↗