EndoWrist 48630GRecalls & reported problems

Summary

The FDA's MAUDE database contains 30 adverse event reports that list this exact device (DI 00886874112847), received between Mar 25, 2021 and Sep 29, 2026 — classified as 11 injuries, 19 malfunctions.

The most frequently reported specific device problem is “Firing Problem” (11 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 30 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 29, 2026Firing Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50940610 ↗
• InjuryJun 11, 2025Firing Problem; Firing Problem

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED PULMONARY LOBECTOMY PROCEDURE, A PARTIAL FIRE OCCURRED WHEN THE GREEN SUREFORM 30 RELOAD STOPPED MIDWAY THROUGH DEPLOYMENT, REQUIRING A MORE EXTENSIVE CLOSURE OF THE PULMONARY BRONCHUS. ALTHOUGH CLAMPING INITIALLY FUNCTIONED AS EXPECTED AN ERROR MESSAGE ¿UNABLE TO COMPLETE FIRE, BLADE MAY BE EXPOSED¿ WAS DISPLAYED DURING THE PARTIAL FIRE. THE SURGEON DID NOT ENCOUNTER ANY OBSTRUCTIONS, SUCH AS CLIPS, STAPLES, OR OTHER HARD MATERIALS BETWEEN THE INSTRUMENT JAWS; HOWEVER, THE BRONCHIAL TISSUE WAS DESCRIBED AS THICK. TO ADDRESS THE DEFECT, A SERIES OF SUTURES WERE PLACED ALONG ITS LENGTH TO RETRACT THE TISSUE, ALLOWING A SECOND STAPLE RELOAD TO BE SUCCESSFULLY FIRED ACROSS THE OPEN AREA. WHILE THERE WAS NO BLEEDING, THE STAPLING EVENT RESULTED IN UNPLANNED TISSUE REMOVAL. HEMOSTATIC GLUE WAS ALSO APPLIED TO REINFORCE THE CLOSURE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED ROBOTICALLY.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 22187323 ↗
• MalfunctionMar 4, 2025Firing Problem; Firing Problem

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED PULMONARY LOBECTOMY SURGICAL PROCEDURE, THE CURVED-TIP 30 STAPLER INSTRUMENT DID NOT COMPLETE THE FIRE. THE CUSTOMER STATED IT FIRED 15MM AND THEN THEY RECEIVED A "BLADE IS EXPOSED" MESSAGE. THE CUSTOMER STATED THEY WERE CLAMPED ON A VESSEL, AND THEY WERE ABLE TO REMOVE THE CURVED-TIP 30 STAPLER SAFELY. THE CUSTOMER STATED THEY WERE USING THE STAPLER WITH A GREEN LOAD. THE CUSTOMER STATED THEY TRIED ANOTHER CURVED-TIP 30 STAPLER, AND THEY HAD THE SAME ISSUE. THE STAPLER FIRED 19MM AND THEN THE BLADE EXPOSED MESSAGE OCCURRED. THE CUSTOMER STATED THEY MAY BE USING A STAPLER THAT WAS TOO SMALL FOR THE VESSEL THEY WERE TRYING TO TAKE DOWN AND THAT THEY SHOULD MAYBE USE A STAPLER 45. THE TECHNICAL SUPPORT ENGINEER (TSE) VIEWED THE SYSTEM LOGS AND SAW AN ERROR 1164 INDICATING THERE WAS NO STAPLER CARTRIDGE FOUND ON UNIVERSAL SURGICAL MANIPULATOR (USM) 3. THE LOGS ALSO SHOWED AN ERROR 22030 INDICATING STAPLER 30MM FAILED IN ITS OPERATION-FIRING MODE FAILURE ON SERIAL NUMBER 2212090064. THE CUSTOMER STATED THE SURGEON WAS GOING TO TRY A HANDHELD STAPLER OR A SUREFORM 45 STAPLER. THE CUSTOMER CONTINUED WITH THE CASE. THE PROCEDURE WAS COMPLETE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21518771 ↗
• MalfunctionJan 28, 2025Firing Problem; Firing Problem

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED PULMONARY LOBECTOMY SURGICAL PROCEDURE, THE CUSTOMER WAS ATTEMPTING TO STAPLER THE BRONCHUS USING THE STAPLER 30 INSTRUMENT AND GREEN RELOAD. DURING FIRING, THE INSTRUMENT STOPPED WITH A MESSAGE ¿REMOVE STAPLER WARNING BLADE MAY BE EXPOSED." SUBSEQUENTLY, A MESSAGE APPEARED ¿UNABLE TO COMPLETE FIRE. TAP BLUE PEDAL TO UNCLAMP THEN REMOVE STAPLER. WARNING BLADE MAY BE EXPOSED." THEREFORE, THE CUSTOMER REMOVED THE STAPLER AND REPLACED IT WITH A SUREFORM 60 GREEN RELOAD AND STARTED STAPLING. IT WAS OBSERVED THAT SOME OF THE TITANIUM STAPLES WERE STUCK IN THE STAPLER/RELOAD WITHOUT BEING ENGAGED. NO FRAGMENT FELL INTO THE PATIENT. THE CUSTOMER COMPLETED THE PROCEDURE, AND NO KNOWN IMPACT OR PATIENT CONSEQUENCE WAS REPORTED. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE ISSUE OCCURRED ON THE FIRST STAPLER FIRE. BRONCHUS STAPLING WAS BEING PERFORMED AT THE TIME OF THE EVENT. THE BRONCHUS WAS THE TARGET TISSUE. THE TISSUE WAS NOT CALCIFIED. THE TISSUE WAS NOT EXPOSED TO ANY RADIATION OR CHEMOTHERAPY PRIOR TO THE PROCEDURE. THERE WAS NOT ANY TISSUE TENSION. THERE WAS

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21254018 ↗
• MalfunctionJan 11, 2024Firing Problem; Firing Problem

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE CUSTOMER ENCOUNTERED A PARTIAL FIRE WITH THE CURVED-TIP STAPLER 30 INSTRUMENT. A GREEN RELOAD WAS INSTALLED INSIDE THE INSTRUMENT. ERROR MESSAGE DISPLAYED WAS ¿BLADE MAY BE EXPOSED¿. 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 INSTRUMENT WAS INSPECTED PRIOR TO USE AND NO DAMAGE WAS NOTED. THE ISSUE OCCURRED ON THE SECOND STAPLER FIRE. THE SURGICAL TASK BEING PERFORMED WAS STAPLING. THE TARGET TISSUE WAS AN ARTERY. THE TISSUE WAS NOT EXPOSED TO ANY RADIATION OR CHEMOTHERAPY. THE TISSUE WAS NOT CALCIFIED. THERE WAS NO TISSUE TENSION AND NO TISSUE BUNCHING. THE CUSTOMER CONFIRMED THE ISSUE WAS FAILURE TO COMPLETE THE FIRING CYCLE AND THE INSTRUMENT PARTIALLY FIRED. THE BLADE WAS EXPOSED. THE RELOAD WAS NOT STUCK TO TISSUE. THE SURGEON DID NOT ENCOUNTER ANY OBSTRUCTIONS SUCH AS CLIPS, STAPLES, OR OTHER HARD MATERIAL BETWEEN THE INSTRUMENT JAWS. THERE WAS NO BUTTRESS MATERIAL USED. THERE WERE NO CLAMPING ISSUES PRIOR TO FIRING. THERE WAS NO OBSERVED BLEEDING. THERE WAS NO UNPLANNED TIS

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18499421 ↗
• MalfunctionJan 8, 2024Firing Problem; Firing Problem

  REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18467575 ↗
• InjuryNov 8, 2023Firing Problem; Firing Problem

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED PULMONARY LOBECTOMY SURGICAL PROCEDURE, WHILE USING THE ENDOWRIST 30 CURVED TIP STAPLER INSTRUMENT ACROSS THE BRONCHUS, A PARTIAL FIRE OCCURRED WHEN FIRING A BLUE 30 RELOAD ACCESSORY, FOLLOWED BY A GREEN 30 RELOAD ACCESSORY. THE BRONCHUS WAS CLEAN WITH NO TISSUE OR LYMPH NODES AROUND THE BRONCHUS AT THE TIME OF CLAMPING AND FIRING. THE FIRST FIRE, STAPLES WERE DEPLOYED AND THE TISSUE WAS CUT; BUT THE RELOAD ABORTED FIRING HALFWAY THROUGH, WITH THE BLADE EXPOSED UPON REMOVAL. THE SECOND FIRE, WAS PLACED OVER THE PREVIOUS ATTEMPTED FIRE, STAPLES WERE DEPLOYED AND THE TISSUE WAS CUT; BUT THE RELOAD ABORTED FIRING HALFWAY THROUGH AGAIN. SURGEON WAS NOT CONFIDENT THAT FORMED STAPLES WERE SEEN PASS THE CUT LINE. THE SURGEON THEN SWITCHED TO THE SUREFORM 45 STAPLER INSTRUMENT AND FIRED A BLACK 45 RELOAD ACCESSORY AND COMPLETED THE FIRE. SURGEON STATED THERE WAS NO BLEEDING, AND NO TISSUE BEING PUSHED FORWARD OR DRAGGED DURING THE FIRING PROCESS. THERE WERE NO POST-OPERATIVE COMPLICATIONS AND THE PATIENT WAS DISCHARGED HOME. THE PROCEDURE WAS COMPLETED ROBOTICALLY WITH NO REPORTED INJURY.

  Patient problems: Insufficient Information

  MAUDE report 18097195 ↗
• MalfunctionSep 22, 2023Firing Problem; Firing Problem

  REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17803745 ↗
• MalfunctionJul 14, 2023Failure to Fire; Failure to Fire

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED PULMONARY WEDGE RESECTION SURGICAL PROCEDURE, THE STAPLER 30 INSTRUMENT INSTALLED WITH A GREEN RELOAD STOPPED HALFWAY AND THE SYSTEM DISPLAYED ERROR CODE 22030 WITH A PROMPT INSTRUCTING THE USER TO REMOVE THE INSTRUMENT. THE STAPLE LINE HAD GONE THROUGH BUT DID NOT CUT. THE INSTRUMENT WAS REMOVED, THE RELOAD WAS REPLACED, AND THE SURGICAL TASK WAS COMPLETED USING THE SAME INSTRUMENT AND ANOTHER RELOAD WITH NO FURTHER ISSUES. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) COMPLETED CUSTOMER FOLLOW UP AND OBTAINED THE FOLLOWING: THE INSTRUMENT AND RELOAD WAS INSPECTED PRIOR TO USE AND EVERYTHING LOOKED NORMAL. THE ISSUE OCCURRED ON THE 2ND STAPLE FIRE WITH A GREEN RELOAD AND THE STAPLER INSTRUMENT WORKED PROPERLY ON EVERY FIRE PERFORMED. THE SURGEON WAS STAPLING ACROSS LUNG TISSUE AT THE TIME OF THE EVENT AND THE TARGET TISSUE WAS THE BRONCHUS. AS THE RELOAD BEGAN TO FIRE IT MADE IT ACROSS HALFWAY AND STOPPED. THERE WAS A PARTIAL FIRE AND THE INSTRUMENT FAILED. THE SURGEON DID NOT OBSERVE ANY TISSUE PUSHED FORWARD/DRAGGED DURING THE FIRING PROCESS NOR WERE THE INSTRUMENT JAWS OPENED/RELEASED DURING F

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17326568 ↗
• MalfunctionJun 13, 2023Failure to Form Staple; Failure to Form Staple

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED PULMONARY LOBECTOMY SURGICAL PROCEDURE, THE STAPLER 30 FAILED TO FIRE. THE CUSTOMER SWITCHED TO A STAPLER 45 TO COMPLETE THE STAPLING. SYSTEM LOGS CONFIRMED FAILURE DURING FIRING OF STAPLER 30MM. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER ON AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: IT WAS CONFIRMED THAT THE INSTRUMENT WAS INSPECTED WITH NO NOTED DAMAGE. IT WAS A GREEN RELOAD WHEN THE ISSUE OCCURRED. THE STAPLER DID WORK PREVIOUSLY. IT WAS UNKNOWN ON WHICH FIRE THE ISSUE OCCURRED. WHEN THE ISSUE OCCURRED, THE STAPLER CLAMPED DOWN, STARTED TO FIRE AND PRESENTED AN ERROR MESSAGE ¿LOAD DID NOT FIRE COMPLETELY¿. THE BLADE PUSHED OUT ROUGHLY 5 MM AND DEPLOYED SOME OF THE STAPLES ON THE PROXIMAL END. THERE WERE MALFORMED STAPLES THAT LOOKED LIKE A BOX SHAPE (OPTION U ON ATTACHED MALFORMED STAPLES CHART). THE SURGEON REMOVED ALL PARTIALLY FIRED STAPLES. NO TISSUE WAS REMOVED. A NEW STAPLER WAS OPENED TO RESOLVE THE ISSUE. THERE WERE NO OBSTRUCTIONS SUCH AS CLIPS, STAPLES, OR OTHER HARD MATERIAL BETWEEN THE INSTRUMENT JAWS. THERE WAS NO ADDITIONAL BLEEDING

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17122181 ↗
• MalfunctionJun 7, 2023Misfire; Misfire

  REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17084041 ↗
• MalfunctionJun 7, 2023Failure to Form Staple; Failure to Form Staple

  REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17083993 ↗
• MalfunctionJun 5, 2023Retraction Problem; Retraction Problem

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED PULMONARY LOBECTOMY SURGICAL PROCEDURE, THE CUSTOMER USED THE STAPLER 30 CURVED INSTRUMENT WITH THE STAPLER 30 GREEN RELOAD AND COMPLETED CLAMPING BUT ERROR "BLADE MAY BE EXPOSED OCCURRED WHILE FIRING. THE CUSTOMER REMOVED THE INSTRUMENT FROM THE ARM AND FOUND ONLY HALF OF STAPLING WAS COMPLETED, AND THE BLADE WAS EXPOSED. THE CUSTOMER USED THE THORACOSCOPY STAPLER TO CONTINUE WITH THE PROCEDURE. THERE WAS NO REPORT OF FRAGMENT(S) FALLING INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITH NO REPORT OF PATIENT HARM, ADVERSE OUTCOME, OR INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE INSTRUMENT WAS INSPECTED PRIOR TO USE WITH NO DAMAGE IDENTIFIED. WHEN THE STAPLER WAS IN USE FOR ABOUT 20 MINUTES, A BLADE MAY BE EXPOSED MESSAGE APPEARED DURING THE SECOND FIRE AFTER CLAMPING. THE SURGEON DID NOT EXPERIENCE ANY CLAMPING ISSUES PRIOR TO FIRING THE STAPLER RELOAD NOR ENCOUNTER ANY OBSTRUCTIONS SUCH AS CLIPS, STAPLES, OR OTHER HARD MATERIAL BETWEEN THE INSTRUMENTS JAWS. THERE WERE NO MALFORMED STAPLES. THE BRONCHUS TISSUE WAS NOT CALCIFIED OR EXPOSED TO ANY

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17067435 ↗
• MalfunctionMay 27, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED PULMONARY WEDGE RESECTION SURGICAL PROCEDURE, THE SURGEON WAS STAPLING ACROSS LUNG TISSUE. THE STAPLING SEQUENCE DID NOT COMPLETE, AND A WARNING OF BLADE MAY BE EXPOSED CAME ON SCREEN. THE CUSTOMER REMOVED THE STAPLER INSTRUMENT AS WELL AS THE STAPLER 30 RELOAD (GREEN) AND TRIED STAPLING AGAIN WITH A DIFFERENT RELOAD AND HAD NO PROBLEMS. THE CUSTOMER IS SENDING THE STAPLER INSTRUMENT WITH THE STAPLER 30 RELOAD (GREEN). THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17015749 ↗
• InjuryMay 13, 2023Retraction Problem; Retraction Problem

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED PULMONARY LOBECTOMY SURGICAL PROCEDURE, WHEN THE GREEN RELOAD WAS USED FOR DISSECTING THE BRONCHI, THERE WAS NO PARTICULAR PROBLEM WITH CLAMPING NOR WAS THE TISSUE FORCED INTO THE JAW; HOWEVER, WHEN FIRED, THE BLADE STOPPED AND A PARTIAL FIRE EVENT OCCURRED. IT WAS REPORTED THAT AFTER REMOVING THE "NON-FORMED" STAPLES, THE SURGEON USED ANOTHER GREEN RELOAD FOR SEPARATION. IT WAS FURTHER REPORTED THAT AN EXTERNAL STAPLER INSTRUMENT (GIA BLACK) WAS ALSO USED FOR THE SURGICAL TASK AND A SIMILAR ISSUE WAS ALSO EXPERIENCED. THE REPORTER NOTED THAT THE BRONCHI WAS NOT PARTICULARLY THICK NOR WAS HARD TISSUE CLAMPED IN BETWEEN THE JAWS WHEN THE PARTIAL FIRE EVENT OCCURRED. THE DOCTOR REPORTEDLY FELT THAT THE FREQUENCY OF GREEN RELOAD PROBLEMS HAS INCREASED RECENTLY. 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 INSTRUMENT/ACCESSORY WAS INSPECTED PRIOR TO USE AND THERE WAS NO DAMAGE OR ANYTHING OUT OF THE ORDINARY. THE FOURTH STAPLER FIRE WAS INVOLVED WITH THE REPORTED EVENT. AN ERROR MESSAGE OF "BLADE M

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16925189 ↗
• MalfunctionMay 1, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED LOW ANTERIOR RESECTION SURGICAL PROCEDURE, THE CUSTOMER REPORTED THAT THE ENDOWRIST STAPLER 30 GREEN RELOAD FAILED TO CUT. THE CUSTOMER USED A NEW RELOAD TO CONTINUE WITH THE PROCEDURE. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE SAFETY CONTROL SPECIALIST AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THERE WAS NO FRAGMENT FALLING INSIDE THE PATIENT¿S ANATOMY. THE PATIENT HAS NOT RETURNED TO THE HOSPITAL FOR ANY POST-SURGICAL COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16850688 ↗
• InjuryMar 23, 2023Firing Problem; Firing Problem

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED PULMONARY LOBECTOMY PROCEDURE, THE CURVED-TIP STAPLER 30 HAD A PARTIAL FIRE, AND THE BLADE WENT ONLY HALFWAY. A BACKUP INSTRUMENT WAS USED; HOWEVER, THE SAME ISSUE WAS ENCOUNTERED. THE ISSUE OCCURRED ON THE SAME ARM AND THERE WERE NO DRAPING ISSUES. THE STAPLES WERE RETRIEVED ON THE SAME PROCEDURE; HOWEVER, IT WAS UNKNOWN IF ALL LOOSE STAPLES OR FRAGMENTS WERE RETRIEVED DUE TO BLEEDING. THERE WAS PROCEDURE DELAY OF AT LEAST 30 MINUTES. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE SURGEON AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE INSTRUMENTS WERE INSPECTED PRIOR TO USE AND NO ISSUES WERE OBSERVED. A SUREFORM 45 WAS USED TO COMPLETE THE CASE ROBOTICALLY. THE SURGICAL SITE BEING STAPLED TOGETHER WAS BRONCHUS AND THERE WAS NO BLEEDING. THERE WERE NO POST-OPERATIVE COMPLICATIONS DUE TO THE EVENT. THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION.

  Patient problems: Foreign Body In Patient

  MAUDE report 16597040 ↗
• InjuryMar 22, 2023Detachment of Device or Device Component; Firing Problem; Detachment of Device or Device Component; Firing Problem

  REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.

  Patient problems: Foreign Body In Patient

  MAUDE report 16593219 ↗
• InjuryDec 13, 2022Failure to Fire; Failure to Fire

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED PULMONARY LOBECTOMY PROCEDURE, AN INCOMPLETE STAPLE LINE WAS IDENTIFIED AFTER A GREEN STAPLER 30 RELOAD WAS FIRED WITH A CURVED-TIP STAPLER 30 INSTRUMENT. AS A RESULT, THE STAPLE LINE WAS OOZING. INTUITIVE SURGICAL, INC. (ISI) CONTACTED THE ISI CLINICAL SALES REPRESENTATIVE (CSR) AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT: THE CSR STATED SHE HAD DISCUSSED THE INCIDENT WITH THE SURGEON. THE SURGEON FIRED A CURVED-TIP STAPLER 30 INSTRUMENT ON UNSPECIFIED TISSUE (UNKNOWN RELOAD COLOR AND WHICH STAPLE FIRE). THE STAPLER INSTRUMENT MADE A GRINDING NOISE AND WOULD NOT COMPLETE THE FIRE. AN UNSPECIFIED ERROR MESSAGE INDICATING A FIRING ISSUE WAS GENERATED. AN INCOMPLETE STAPLE LINE AND OOZING WERE IDENTIFIED IN ADDITION TO SOME MALFORMED STAPLES. AS A RESULT OF THE STAPLING ISSUE, A NEW UNSPECIFIED STAPLER INSTRUMENT WAS OPENED BY THE SURGICAL STAFF AND THE SURGEON FIRED ANOTHER RELOAD. 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: Unspecified Tissue Injury

  MAUDE report 15965684 ↗
• MalfunctionNov 11, 2022Difficult to Remove; Failure to Form Staple; Failure to Fire; Difficult to Remove; Failure to Form Staple; Failure to Fire

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED PULMONARY LOBECTOMY PROCEDURE, TWO ENDOWRIST 30 CURVED TIP STAPLER INSTRUMENTS EXPERIENCED FIRING FAILURES. THE ISSUE OCCURRED WHILE STAPLING ACROSS THE LEFT UPPER BRONCHUS. THE INITIAL ENDOWRIST 30 STAPLER (BN: 0036) DID NOT GO THROUGH THE ENTIRE RELEASE SEQUENCE, STOPPING HALLWAY THROUGH WITHOUT FINISHING, WHILE INSTALLED IN UNIVERSAL SURGICAL MANIPULATOR 1 (USM1). THIS OCCURRED DURING THE FOURTH FIRE WITH A GREEN RELOAD. WHITE RELOADS WERE USED PRIOR TO THE GREEN WITHOUT ISSUE. THE ENDOWRIST 30 STAPLER CUT ACROSS THE STAPLE LINE; THE SURGEON BELIEVES THAT THE CUTTING BLADE OF THE GREEN STAPLER 30 RELOAD WENT PAST THE STAPLE LINE AND CUT THE BRONCHUS. MALFORMED STAPLES WERE OBSERVED. A SECOND BACKUP ENDOWRIST 30 STAPLER (BN: 0008) WAS THEN INSTALLED TO ATTEMPT TO STAPLE ACROSS THE STAPLE LINE, BUT IT ALSO ENCOUNTERED A FIRING FAILURE WHILE USING A GREEN STAPLER 30 RELOAD. THE ONE AND ONLY ATTEMPTED FIRE WITH THE SECOND ENDOWRIST 30 STAPLER WENT ACROSS PREVIOUS STAPLES. MALFORMED STAPLES WERE OBSERVED. THE FIRING FAILURE ISSUES OCCURRED WITH GREEN RELOADS IN BOTH ENDOWRIST 30 STAPLERS. THE TECHNICAL SERVICE ENGINEER VIEWED THE LIVE L

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15785511 ↗
• InjuryNov 11, 2022Failure to Form Staple; Failure to Fire; Failure to Form Staple; Failure to Fire

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED PULMONARY LOBECTOMY PROCEDURE, TWO ENDOWRIST 30 CURVED TIP STAPLER INSTRUMENTS EXPERIENCED FIRING FAILURES. THE ISSUE OCCURRED WHILE STAPLING ACROSS THE LEFT UPPER BRONCHUS. THE INITIAL ENDOWRIST 30 STAPLER (BN: 0036) DID NOT GO THROUGH THE ENTIRE RELEASE SEQUENCE, STOPPING HALLWAY THROUGH WITHOUT FINISHING, WHILE INSTALLED IN UNIVERSAL SURGICAL MANIPULATOR 1 (USM1). THIS OCCURRED DURING THE FOURTH FIRE WITH A GREEN RELOAD. WHITE RELOADS WERE USED PRIOR TO THE GREEN WITHOUT ISSUE. THE ENDOWRIST 30 STAPLER CUT ACROSS THE STAPLE LINE; THE SURGEON BELIEVES THAT THE CUTTING BLADE WENT PAST THE STAPLE LINE AND CUT THE BRONCHUS. MALFORMED STAPLES WERE OBSERVED. A SECOND BACKUP ENDOWRIST 30 STAPLER (BN: 0008) WAS THEN INSTALLED TO ATTEMPT TO STAPLE ACROSS THE STAPLE LINE, BUT IT ALSO ENCOUNTERED A FIRING FAILURE WHILE USING A GREEN RELOAD. THE ONE AND ONLY ATTEMPTED FIRE WITH THE SECOND ENDOWRIST 30 STAPLER WENT ACROSS PREVIOUS STAPLES. MALFORMED STAPLES WERE OBSERVED. THE FIRING FAILURE ISSUES OCCURRED WITH GREEN RELOADS IN BOTH ENDOWRIST 30 STAPLERS. THE TECHNICAL SERVICE ENGINEER VIEWED THE LIVE LOGS AND NOTED ENGAGEMENT ERRORS ON USM1. P

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15785508 ↗
• InjuryJul 21, 2022Failure to Fire; Failure to Fire

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED PULMONARY LOBECTOMY PROCEDURE ON (B)(6) 2022, THE ENDOWRIST 30 CURVED-TIP STAPLER DID NOT COMPLETE THE STAPLE LINE. THE DA VINCI XI SCREEN SHOWED "FAULTED, BLADE MAY BE EXPOSED". THE SURGEON PROCEEDED WITH THE USE OF ANOTHER ENDOWRIST 30 CURVED-TIP STAPLER AND RELOADS. THE PROCEDURE WAS COMPLETED AS PLANNED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING INFORMATION: AFTER TWO SUCCESSFUL STAPLER FIRES, WHILE ATTEMPTING TO FIRE THE STAPLER ACROSS A PULMONARY VESSEL, THE STAPLER SUCCESSFULLY CLAMPED DOWN AND STAPLED, HOWEVER, THE BLADE ONLY CUT FROM WHERE THE STAPLER FIRES TO HALFWAY ACROSS THE STAPLE LINE. THERE WERE NO HOLES OR GAPS OBSERVED IN THE STAPLE LINE AND NO UNEXPECTED BLOOD LOSS. THE INITIAL REPORTER NOTED THAT, ALTHOUGH THERE WERE NO STAPLES MISSING FROM THE STAPLE LINE, THE STAPLES APPEARED TO BE BUNCHED TOGETHER, NOT WITH THE EXPECTED SPACING. THE REPORTED ISSUE OCCURRED DURING THE THIRD FIRING OF THE STAPLER. THE DA VINCI XI SYSTEM GENERATED THE FOLLOWING ERRORS/MESSAGES: "UNABLE TO COMPLETE FIRE," "BLADE MAY BE EXPOSED," AND "REMOVE INSTRUMENT." LO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15071256 ↗
• MalfunctionJun 24, 2022Misfire; Failure to Form Staple; Misfire; Failure to Form Staple

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED LOW ANTERIOR RESECTION SURGICAL PROCEDURE, A MISFIRE WAS NOTED WHILE USING A CURVED-TIP STAPLER 30 INSTRUMENT AND A GREEN RELOAD. THE SURGEON FIRED AGAIN TO RESOLVE THE ISSUE. SOME OF THE STAPLES WERE NOT REMOVED. THE PROCEDURE WAS COMPLETED. ON 11-MAY-2021 INTUITIVE SURGICAL INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE CUSTOMER WAS WORKING ON THE BOWEL (STAPLING INTESTINE) WHEN THE ISSUE OCCURRED AND IT WAS THE SECOND RELOAD USE OF THE PROCEDURE. REPORT OF STAPLER MISFIRE AND LOOSE STAPLES. NO ADDITIONAL INTERVENTION WAS NEEDED. NO BLOOD LOSS OR PATIENT INJURY WAS NOTED. BUTTRESS MATERIAL WAS NOT USED AND THERE WERE NO MALFORMED STAPLES. THE INSTRUMENT/ACCESSORY WAS INSPECTED PRIOR TO USE AND NO DAMAGE OR ABNORMALITIES WERE NOTED. THE SURGEON WAS USING THE GREEN RELOAD TO ACHIEVE ANASTOMOSIS. THE STAPLER INSTRUMENT WAS IN USE THE ENTIRE CASE. THERE WAS NO CLAMPING ISSUE NOTED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14796739 ↗
• InjuryMay 15, 2022Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem; Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED LOW ANTERIOR RESECTION WITH DIVERTING LOOP ILEOSTOMY, THE SUREFORM 60 STAPLER INSTRUMENT EXPERIENCED A PARTIAL FIRE WHILE FIRING A BLUE RELOAD ON THE DISTAL RECTUM. A BLADE EXPOSED MESSAGE WAS RECEIVED DURING THIS FIRING EVENT. THIS SUREFORM 60 STAPLER INSTRUMENT HAD BEEN USED TO FIRE TWO RELOADS SUCCESSFULLY PRIOR TO THIS EVENT. THE SURGEON REPORTED THAT THERE WAS NO BLEEDING AS A RESULT OF THIS PARTIAL FIRE. THE CUSTOMER REPLACED THE SUREFORM 60 STAPLER INSTRUMENT WITH A SUREFORM 30 STAPLER INSTRUMENT TO CONTINUE THIS FIRE. THE SUREFORM 30 STAPLER WAS LOADED WITH A GREEN RELOAD AND FIRED, BUT THIS FIRE ALSO RESULTED IN A PARTIAL FIRE OF THE DISTAL RECTUM TISSUE. THE SURGEON REPORTED THAT THEY DISSECTED A PORTION OF THE DISTAL RECTUM TISSUE WITH THE DA VINCI MONOPOLAR CURVED SCISSORS (MCS) INSTRUMENT THAT WAS ALREADY IN USED DURING THIS PROCEDURE. THE SURGEON THEN SUTURED THE TISSUE. THE TECHNICAL SUPPORT ENGINEER (TSE) DID NOT OBSERVE ANY SUREFORM OR UNIVERSAL SURGICAL MANIPULATOR (USM) ERRORS IN THE SYSTEM LOGS DURING THIS PROCEDURE. THE SURGEON REPORTED THAT THIS EVENT ADDED TIME TO THE CASE WHICH WAS COMPLETED SUCCESSFULLY. THE S

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14404009 ↗
• InjuryMay 2, 2022Firing Problem; Firing Problem

  DURING A DA VINCI-ASSISTED PULMONARY LOBECTOMY PROCEDURE, THERE WAS A FIRING ISSUE WITH THE CURVED-TIP STAPLER 30 INSTRUMENT. A GREEN STAPLER RELOAD WAS USED TO STAPLE ACROSS THE BRONCHUS AND DURING THE FIRING SEQUENCE, THE STAPLER COULD NOT COMPLETE A FIRE AND A POTENTIAL EXPOSED BLADE MESSAGE APPEARED. WHEN THE SURGEON UNCLAMPED THE STAPLER INSTRUMENT, THE STAPLES THAT FIRED WERE "COMPROMISED" ACCORDING TO THE INITIAL REPORTER. IT WAS NOTED THAT THE STAPLE LINE ENDED HALF-WAY THROUGH AND THE SURGEON HAD TO CONVERT TO A VIDEO ASSISTED THORACIC SURGERY (VATS) PROCEDURE FOR THE REMAINDER OF THE CASE DUE TO THE STAPLING ISSUE. INTUITIVE SURGICAL, INC (ISI) HAS REACHED OUT TO THE ROBOTICS COORDINATOR TO OBTAIN ADDITIONAL INFORMATION BUT HAS NOT YET RECEIVED A RESPONSE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Unspecified Tissue Injury

  MAUDE report 14257584 ↗