EndoWrist;daVinci Si 410322Recalls & reported problems

Summary

The FDA's MAUDE database contains 56 adverse event reports that list this exact device (DI 00886874111116), received between Dec 22, 2016 and Aug 22, 2024 — classified as 9 injuries, 47 malfunctions.

The most frequently reported specific device problem is “Failure to Deliver Energy” (19 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 56 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 22, 2024Difficult to Open or Close; Difficult to Open or Close

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED DISTAL GASTRECTOMY SURGICAL PROCEDURE, THE TIPS OF THE VESSEL SEALER WERE NOT OPENING OR CLOSING WHILE THE INSTRUMENT WAS INSTALLED ONTO THE UNIVERSAL SURGICAL MANIPULATOR (USM). THE CUSTOMER NOTED THAT THE REPORTED EVENT CONTINUED TO OCCUR WHEN THE VESSEL SEALER WAS REMOVED MANUALLY. THE PROCEDURE WAS COMPLETING AS PLANNED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE CUSTOMER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: IT WAS UNKNOWN IF THE VESSEL SEALER EXTEND (VSE) WORKED AT ALL DURING THIS PROCEDURE. IT WAS UNKNOWN IF THE JAWS WERE STUCK ON TISSUE WHEN THE ISSUE OCCURRED. ALSO, IT WAS UNKNOWN IF THERE WAS ANY ADVERSE EFFECT TO GRASPED TISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20044924 ↗
• MalfunctionApr 22, 2024Difficult to Open or Close; Difficult to Open or Close

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED RADICAL PROSTATECTOMY WITH LYMPHADENECTOMY SURGICAL PROCEDURE, THE VESSEL SEALER (VS) INSTRUMENT COULD NOT BE USED. A SYSTEM MESSAGE "INSTRUMENT NOT CONNECTED TO INSTRUMENT CONTROL BOX" APPEARED ON THE VISION SIDE CART (VSC) MONITOR, AND PORT INDICATOR WAS ILLUMINATED RED. THE CUSTOMER RECEIVED PHONE ASSISTANCE FROM THE TECHNICAL SUPPORT ENGINEER (TSE). TSE HAD THE CUSTOMER PERFORM THE FOLLOWING STEPS: RESEAT THE ENERGY, ACTIVATION AND JUMPER CABLE, POWER CYCLE VIO DV INTEGRATED ELECTROSURGICAL UNIT (IESU) GENERATOR, AND TURN OFF THE CIRCUIT BREAKER, BUT ERROR CODE 32030 OCCURRED. AFTER THIS, THE CUSTOMER REPORTED THAT THE VS INSTRUMENT JAWS COULD NOT BE OPENED WHILE GRASPING THE PATIENT¿S TISSUE. THE CUSTOMER USED AN INSTRUMENT RELEASE KIT (IRK) TO OPEN THE JAWS, BUT THE ISSUE WAS NOT RESOLVED. EVENTUALLY, THE ASSISTANT SURGEON MANUALLY OPENED THE VS JAWS BY USING A LAPAROSCOPIC INSTRUMENT. THE CUSTOMER USED A BACKUP VS INSTRUMENT TO CONTINUE WITH THE PROCEDURE. THE PROCEDURE WAS CONTINUED WITH NO REPORTED INJURY. ISI FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE VS INSTRUMENT WAS INSPEC

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19160671 ↗
• MalfunctionJun 6, 2023Failure to Deliver Energy; Visual Prompts will not Clear; No Apparent Adverse Event; Failure to Deliver Energy; Visual Prompts will not Clear; No Apparent Adverse Event

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SLEEVE GASTRECTOMY SURGICAL PROCEDURE, THE VESSEL SEALER INSTRUMENT WOULD NOT SEAL, AND THE CUSTOMER RECEIVED AN ERROR MESSAGE INDICATING THAT THE SOFTWARE WAS OUT OF DATE. IT WAS REPORTED THAT AN AUDIBLE SIGNAL (CONTINUOUS TONE) WAS HEARD WHILE THE PEDAL WAS PRESSED. THE CUSTOMER STATED THAT NO TISSUE EFFECT WAS OBSERVED DURING THE SEALING CYCLE AND THERE WAS NO EVIDENCE OF VESSEL CALCIFICATION. ACCORDING TO THE CUSTOMER, THERE ARE NO PHOTOGRAPHIC IMAGES OF THE DEVICE(S) OR A VIDEO RECORDING OF THE PROCEDURE AVAILABLE FOR REVIEW. THE CUSTOMER COULD NOT GET THE VESSEL SEALER INSTRUMENT TO WORK ON THE SYSTEM. THE CUSTOMER STATED THAT THEY CHECKED THE CABLE CONNECTIONS AND FOUND EVERYTHING CONNECTED PROPERLY. THE CUSTOMER STATED THAT THEY GOT A MESSAGE STATING THE SOFTWARE MAY BE OUTDATED WHEN INSTALLING THE VESSEL SEALER INSTRUMENT. THE TECHNICAL SUPPORT ENGINEER (TSE) REVIEWED LOGS AND FOUND 32005 FAULTS ON THE SYSTEM. THE TSE ASKED THE CUSTOMER IF THEY TRIED A NEW VESSEL SEALER INSTRUMENT AND THE CUSTOMER STATED THAT THEY DIDN'T. THE PROCEDURE WAS CONVERTED TO LAPAROSCOPIC SURGERY WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (IS

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17067789 ↗
• MalfunctionJun 5, 2023No Device Output; No Device Output

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED TOTAL BENIGN HYSTERECTOMY SURGICAL PROCEDURE, THE CUSTOMER NOTED THE VESSEL SEALER (VS) INSTRUMENT STOPPED WORKING AND WAS NOT RECOGNIZED BY THE SYSTEM. THE VS WORKED FOR THE BEGINNING OF THE CASE THEN STOPPED WORKING. THE CUSTOMER INFORMED THE INSTRUMENT WAS NOT REMOVED PRIOR TO IT HAVING THE FUNCTION ERROR. THERE WAS NO REPORTED INJURY OR HARM. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE ROBOTIC COORDINATOR AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE CUSTOMER CONFIRMED THEY OPENED TWO DIFFERENT VESSEL SEALER (VS) THAT DID NOT WORK, THEN LOST POWER ON THE SURGEON SIDE CONSOLE (SSC), AND THE SURGEON OPTED TO CONVERT TO LAPAROSCOPIC PROCEDURE. IT WAS NOTED THAT THE ERBE INTEGRATED ELECTROSURGICAL UNIT (IESU) GENERATOR WAS NOT RECOGNIZING THE INSTRUMENT AFTER PREVIOUSLY WORKING FINE. THE NURSE DID NOT PERFORM TROUBLESHOOTING WITH TECHNICAL SUPPORT AS THEY WERE CALLED AFTER THE CASE. THE CUSTOMER INFORMED THAT THE SYSTEM WAS INSPECTED PRIOR TO USE AND NO ISSUES WERE NOTED DURING THE SYSTEM SETUP. IT WAS NOTED THE PROCEDURE WAS IN PROGRESS ABOUT 45 TO 50 MINUTES WHEN THE ISSUE OCCURRED. THE CUSTOMER ATTEMPTED TO RESEAT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17067414 ↗
• MalfunctionJun 5, 2023No Device Output; No Device Output

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED TOTAL BENIGN HYSTERECTOMY SURGICAL PROCEDURE, THE CUSTOMER NOTED THE VESSEL SEALER (VS) INSTRUMENT STOPPED WORKING AND WAS NOT RECOGNIZED BY THE SYSTEM. THE VS WORKED FOR THE BEGINNING OF THE CASE THEN STOPPED WORKING. THE CUSTOMER INFORMED THE INSTRUMENT WAS NOT REMOVED PRIOR TO IT HAVING THE FUNCTION ERROR. THERE WAS NO REPORTED INJURY OR HARM. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE ROBOTIC COORDINATOR AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE CUSTOMER CONFIRMED THEY OPENED TWO DIFFERENT VESSEL SEALER (VS) THAT DID NOT WORK, THEN LOST POWER ON THE SURGEON SIDE CONSOLE (SSC), AND THE SURGEON OPTED TO CONVERT TO LAPAROSCOPIC PROCEDURE. IT WAS NOTED THAT THE ERBE INTEGRATED ELECTROSURGICAL UNIT (IESU) GENERATOR WAS NOT RECOGNIZING THE INSTRUMENT AFTER PREVIOUSLY WORKING FINE. THE NURSE DID NOT PERFORM TROUBLESHOOTING WITH TECHNICAL SUPPORT AS THEY WERE CALLED AFTER THE CASE. THE CUSTOMER INFORMED THAT THE SYSTEM WAS INSPECTED PRIOR TO USE AND NO ISSUES WERE NOTED DURING THE SYSTEM SETUP. IT WAS NOTED THE PROCEDURE WAS IN PROGRESS ABOUT 45 TO 50 MINUTES WHEN THE ISSUE OCCURRED. THE CUSTOMER ATTEMPTED TO RESEAT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17067411 ↗
• MalfunctionJun 5, 2023No Device Output; Visual Prompts will not Clear; No Device Output; Visual Prompts will not Clear

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE CUSTOMER STATED THAT THEY HAD ENGAGEMENT ISSUES ON TWO VESSEL SEALER (VS) INSTRUMENTS. THE PROCEDURE WAS CONVERTED TO LAPAROSCOPIC SURGERY. THERE WAS NO REPORTED PATIENT HARM, INJURY, OR ADVERSE OUTCOME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17067408 ↗
• MalfunctionJun 5, 2023No Device Output; Visual Prompts will not Clear; No Device Output; Visual Prompts will not Clear

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE CUSTOMER STATED THAT THEY HAD ENGAGEMENT ISSUES ON TWO VESSEL SEALER (VS) INSTRUMENTS. THE PROCEDURE WAS CONVERTED TO LAPAROSCOPIC SURGERY. THERE WAS NO REPORTED PATIENT HARM, INJURY, OR ADVERSE OUTCOME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17067406 ↗
• MalfunctionJun 2, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SACROCOLPEXY SURGICAL PROCEDURE, THE VESSEL SEALER INSTRUMENT HAD A LOOSE CABLE. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17047814 ↗
• MalfunctionJun 2, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED HYSTERECTOMY SURGICAL PROCEDURE, THE BLADE OF THE VESSEL SEALER INSTRUMENT WAS EXPOSED. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17046669 ↗
• InjuryMay 13, 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 BOTTOM JAW OF THE VESSEL SEALER INSTRUMENT BROKE OFF AND FELL INSIDE THE PATIENT'S ANATOMY. THERE WAS NO DAMAGE TO THE PATIENT. THE CUSTOMER WAS ABLE TO RETRIEVE THE FRAGMENT DURING THE PROCEDURE. 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 FRAGMENT WAS RETRIEVED WITH ANOTHER ROBOTIC INSTRUMENT AND PASSED TO A LAPAROSCOPIC INSTRUMENT AND REMOVED BY THE ASSISTANT. THE PROCEDURE WAS CONVERTED TO OPEN SURGERY FOR REASONS UNRELATED TO THE SYSTEM/ISSUE. THE SURGEON WAS ATTEMPTING TO SEAL TISSUE AND NOTICED THE INSTRUMENT WAS NOT WORKING. HE ASKED FOR IT TO BE TAKEN OUT. WHEN REMOVED, THE SCRUB TECH NOTICED THE JAW HAD BROKEN. THE SURGEON THEN INSPECTED THE AREA, LOCATED THE MISSING PIECE AND RETRIEVED IT. THE INSTRUMENT HAD BEEN USED AND REMOVED A FEW TIMES DURING THE CASE. THE INSTRUMENT WRIST WAS STRAIGHTENED UPON REMOVAL. THE VESSEL SEALER INSTRUMENT DID NOT COLLIDE WITH ANOTHER INSTRUMENT OR HARD MATERIAL DURING THE PROCEDURE. THE INSTRUMENT WAS INSPECTED PRI

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16925251 ↗
• MalfunctionMay 3, 2022Difficult to Open or Close; Difficult to Open or Close

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE JAWS OF THE VESSEL SEALER INSTRUMENT BROKE AND DID NOT OPEN ANYMORE. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER ON (B)(6) 2022 AND (B)(6) 2022, AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE DOCTOR CONFIRMED THAT THE VESSEL SEALER JAWS WERE NOT STUCK ON TISSUE AND THE INSTRUMENT WAS REMOVED FROM THE TISSUE AS USUAL. NO FRAGMENTS FELL INSIDE THAT PATIENT. A BACKUP INSTRUMENT WAS USED TO PROCEED WITH THE SURGICAL TASK. AS A RESULT OF THE ALLEGED ISSUE, THERE WAS A PROCEDURAL DELAY OF 80 MINUTES. THERE WAS NO BROKEN CABLE OBSERVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14265791 ↗
• InjuryJun 5, 2021Energy Output Problem; Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem; Energy Output Problem; Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem

  REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 11944342 ↗
• MalfunctionMay 6, 2021Intermittent Energy Output; Intermittent Energy Output

  REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 11788283 ↗
• MalfunctionMay 5, 2021Difficult 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 VESSEL SEALER (VS) INSTRUMENT FAILED. THE CUSTOMER REPLACED THE VS INSTRUMENT WITH A BACK-UP INSTRUMENT OF THE SAME KIND AND COMPLETED THE PROCEDURE 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 11775456 ↗
• MalfunctionApr 30, 2021Failure to Deliver Energy; Failure to Deliver Energy

  REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11758464 ↗
• MalfunctionMar 16, 2021Difficult to Open or Close; Difficult to Open or Close

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE VESSEL SEALER (VS) INSTRUMENT DID NOT WORK, AND A BACKUP VS INSTRUMENT WAS USED. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. ON FEBRUARY 25, 2021, INTUITIVE SURGICAL (IS) CONTACTED THE SITE AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION REGARDING THIS EVENT: THE ISSUE OCCURRED DURING AN ESOPHAGECTOMY PROCEDURE. THE VS INSTRUMENT WAS INSPECTED PRIOR TO USE AND THERE WAS NO DAMAGE TO THE INSTRUMENT. DISSECTION PARA ESOPHAGEAL (THORACIC STEP) WAS BEING PERFORMED WHEN THE EVENT OCCURRED. THE SURGEON WAS ABLE TO MOVE THE VS INSTRUMENT BUT THE JAWS REMAINED CLOSED ON FATTY TISSUE. THE VS INSTRUMENT WORKED AT THE BEGINNING OF THE PROCEDURE AND WAS IN USE FOR 15 MINUTES PRIOR TO THE ISSUE. THE SURGEON USED A BIPOLAR INSTRUMENT TO REMOVE TISSUE FROM THE VS JAWS. IT WAS ONLY FAT TISSUE AND NOT VESSELS. THE VS INSTRUMENT WAS USED ON PARA ESOPHAGEAL VESSELS AND LEFT GASTRIC VEIN. IT WAS CONFIRMED THAT THERE WAS NO TISSUE TEAR. NO ERROR MESSAGES WERE DISPLAYED. THERE WAS AN AUDIBLE SIGNAL WHILE THE PEDAL WAS PRESSED. THE SEAL CYCLE DID COMPLETE WITH THE FAST AUDIBLE TONES AS EXPECTED. THE TISSUE THAT WAS NOT FUL

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11491208 ↗
• MalfunctionDec 29, 2020Failure to Deliver Energy; Failure to Deliver Energy

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED TOTAL BENIGN HYSTERECTOMY SURGICAL PROCEDURE, THE SURGEON NOTICED THE VESSEL SEALER (VS) INSTRUMENT QUIT WORKING. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE ROBOTIC COORDINATOR AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE ROBOTIC COORDINATOR STATED SHE WAS NOT IN THE CASE AT THE TIME OF THE REPORTED INCIDENT. HOWEVER, WAS INFORMED BY THE SURGEON THAT THE INSTRUMENT WOULD NOT SUFFICIENTLY SEAL. IT WAS STATED THE SURGEON USED A BACKUP VS INSTRUMENT TO CONTINUE THE CASE. NO VIDEO/IMAGE WAS AVAILABLE FOR REVIEW. THE ROBOTIC COORDINATOR CONFIRMED THE PROCEDURE WAS COMPLETED ROBOTICALLY WITH NO PATIENT INJURY OR HARM.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 11085789 ↗
• MalfunctionDec 16, 2020Image Display Error/Artifact; Difficult to Open or Close; Image Display Error/Artifact; Difficult to Open or Close

  IT WAS REPORTED THAT PRIOR TO STARTING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE SYSTEM REFLECTED AN ERROR MESSAGE POINTING TO THE VESSEL SEALER (VS) INSTRUMENT. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 11016766 ↗
• MalfunctionNov 16, 2020Failure to Deliver Energy; Failure to Deliver Energy

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE VESSEL SEALER INSTRUMENT DELIVERED "UNSTABLE ENERGY" AND WOULD NOT FIRE SOMETIMES. THE PROCEDURE WAS COMPLETED WITH NO ADDITIONAL ISSUES. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: IT IS UNKNOWN WHETHER THE INSTRUMENT WAS INSPECTED PRIOR TO USE. THE CLINICAL SALES REPRESENTATIVE (CSR) HEARD THAT THERE WERE MANY TIMES WHEN INADEQUATE SEALING WAS EXPERIENCED. IT IS UNKNOWN HOW LONG THE INSTRUMENT WAS IN USE PRIOR TO THE SEALING ISSUE AND WHETHER ANY ERRORS OCCURRED WHEN THE VESSEL SEALER ISSUE OCCURRED. IT IS ALSO UNKNOWN WHETHER THERE WAS AN AUDIBLE SIGNAL (CONTINUOUS TONE) DURING THE SEALING SEQUENCE WHILE THE PEDAL WAS BEING PRESSED AND WHETHER THE SEAL CYCLE COMPLETED WITH THE FAST AUDIBLE TONES AS EXPECTED. THE TARGET TISSUES WERE THE ROUND LIGAMENT OF THE UTERUS AND CARDINAL LIGAMENT. THE TARGET TISSUE WAS UNDER TENSION DURING THE SEALING/CUTTING PROCESS BUT THE VESSEL WAS NOT GREATER THAN 7 MM IN DIAMETER. THERE WAS NO EVIDENCE OF VESSEL CALCIFICATION AND THE TISSUE WAS NOT EXPOSED TO ANY RADIATION OR CHEMOTHERAPY PRIOR TO THE PRO

  Patient problems: Blood Loss

  MAUDE report 10849227 ↗
• InjuryOct 27, 2020Failure to Deliver Energy; No Apparent Adverse Event; Failure to Deliver Energy; No Apparent Adverse Event

  IT WAS INITIALLY REPORTED THAT DURING A DA VINCI-ASSISTED NEPHRECTOMY PROCEDURE, THE CUSTOMER ALLEGED THAT THE VESSEL SEALER (VS) INSTRUMENT WAS WORKING FOR THE BEGINNING OF THE CASE AND THEN STOPPED WORKING. IN ADDITION, THE CUSTOMER CLAIMED THAT THE INSTRUMENT WAS NOT RECOGNIZED BY THE SYSTEM. IT WAS NOTED THE VS INSTRUMENT WAS NOT REMOVED PRIOR TO HAVING THE ISSUES. THERE WAS NO REPORTED INJURY OR HARM. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE ROBOTICS COORDINATOR AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE ROBOTICS COORDINATOR CONFIRMED THE REPORTED CASE OCCURRED ON (B)(6) 2020 DURING A NEPHRECTOMY PROCEDURE. THE DA VINCI SYSTEM AND VS INSTRUMENT WERE INSPECTED PRIOR TO USE, AND NO ISSUES WERE OBSERVED WITH PORT PLACEMENT. PRIOR TO THE REPORTED ISSUES, THE PROCEDURE HAD BEEN IN PROGRESS FOR 1 TO 2 HOURS. THE ROBOTICS COORDINATOR INDICATED THAT THE PROCEDURE WAS CONVERTED TO TRADITIONAL LAPAROSCOPIC SURGERY ¿DUE TO INADEQUATE VISUALIZATION AND INADEQUATE CAUTERIZATION OF BLEEDING VESSELS.¿ HOWEVER, THE ROBOTICS COORDINATOR INDICATED THAT THERE WAS NO INJURY TO THE PATIENT. THE ROBOTICS COORDINATOR CONFIRMED THAT NO TROUBLESHOOTING WAS PERFORMED WITH TECHNIC

  Patient problems: Blood Loss

  MAUDE report 10744493 ↗
• MalfunctionOct 21, 2020Difficult to Open or Close; Difficult to Open or Close

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SIGMOID COLECTOMY SURGICAL PROCEDURE, THE VESSEL SEALER INSTRUMENT¿S JAWS COULD NOT BE OPENED. NO TISSUE WAS STUCK WITHIN THE JAWS OF THE INSTRUMENT. THE CUSTOMER USED A BACKUP VESSEL SEALER INSTRUMENT TO CONTINUE. THE PROCEDURE WAS COMPLETED WITH NO REPORT OF PATIENT HARM, INJURY, OR ADVERSE OUTCOME. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED-UP WITH THE INITIAL REPORTER, AND RECEIVED THE FOLLOWING ADDITIONAL INFORMATION: THE SURGEON WAS ABLE TO USE THE INSTRUMENT ONCE, AND THEN THE REPORTED ISSUE OCCURRED BEFORE HE COULD USE IT FOR ANOTHER SEAL CYCLE. IT WAS CONFIRMED THAT THERE WAS NO TISSUE IN THE JAWS OF THE INSTRUMENT AT THE TIME OF THE REPORTED ISSUE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10709596 ↗
• MalfunctionSep 29, 2020Failure to Deliver Energy; Failure to Deliver Energy

  REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10598531 ↗
• MalfunctionAug 30, 2020Failure to Deliver Energy; Failure to Deliver Energy

  REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10469717 ↗
• InjuryAug 3, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED HYSTERECTOMY PROCEDURE, THE VESSEL SEALER INSTRUMENT "DID NOT WORK, AND HAD VERY LOW ENERGY.¿ AS A RESULT, THE PATIENT ALLEGEDLY EXPERIENCED "HEAVY BLEEDING," AND THE BLEEDING WAS CONTROLLED WITH A BIPOLAR INSTRUMENT. THE SITE REPORTEDLY CHANGED OUT TO A BACKUP VESSEL SEALER INSTRUMENT; HOWEVER, THERE WAS NO CHANGE. IT WAS REPORTED THAT THE CUSTOMER CONTINUED THE PROCEDURE USING A BIPOLAR INSTRUMENT. ON 07-JUL-2020, INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE PATIENT IS AN AFRICAN AMERICAN FEMALE WHO IS (B)(6) YEARS OLD AND WEIGHS (B)(6) LBS. THE PATIENT¿S MEDICAL HISTORY INCLUDES FIBROIDS AND MENORRHAGIA. DURING THIS PROCEDURE, THERE WERE TWO INSTANCES WHEN TWO DIFFERENT VESSEL SEALER INSTRUMENTS DID NOT ADEQUATELY SEAL. THE FIRST SEQUENCE OF EVENTS WITH THE FIRST VESSEL SEALER INSTRUMENT IS REPORTED IN THE REPORT UNDER PATIENT IDENTIFIER (B)(6). THE SURGEON CONTINUED THE CASE WITH A SECOND VESSEL SEALER INSTRUMENT. WHEN USING THE SECOND VESSEL SEALER INSTRUMENT, IT DID NOT WORK AND THE VESSEL WAS PARTIALLY SEALED. AS A RESULT, THE PATIENT EXPERIENCED "HE

  Patient problems: Blood Loss

  MAUDE report 10359934 ↗
• InjuryAug 3, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED HYSTERECTOMY PROCEDURE, THE VESSEL SEALER INSTRUMENT "DID NOT WORK, AND HAD VERY LOW ENERGY.¿ AS A RESULT, THE PATIENT ALLEGEDLY EXPERIENCED "HEAVY BLEEDING," AND THE BLEEDING WAS CONTROLLED WITH A BIPOLAR INSTRUMENT. THE SITE REPORTEDLY CHANGED OUT TO A BACKUP VESSEL SEALER INSTRUMENT; HOWEVER, THERE WAS NO CHANGE. IT WAS REPORTED THAT THE CUSTOMER CONTINUED THE PROCEDURE USING A BIPOLAR INSTRUMENT. ON 07-JUL-2020, INTUITIVE SURGICAL, INC. (ISI) CONTACTED THE SITE AND OBTAINED THE FOLLOWING INFORMATION REGARDING TO THE REPORTED EVENT: THE PATIENT IS AN AFRICAN AMERICAN FEMALE WHO IS (B)(6) YEARS OLD AND WEIGHS (B)(6) LBS. THE PATIENT¿S MEDICAL HISTORY INCLUDES FIBROIDS AND MENORRHAGIA. IT WAS REPORTED THAT THE SURGEON WAS ABLE TO USE THE VESSEL SEALER INSTRUMENT FOR 30 MINUTES WITHOUT ANY ISSUES UP UNTIL THE EVENT OCCURRED. WHEN THE SURGEON ATTEMPTED TO SEAL AN UNSPECIFIED VESSEL, THE VESSEL SEALER INSTRUMENT DID NOT WORK. THE VESSEL WAS PARTIALLY SEALED. AS A RESULT, THE PATIENT EXPERIENCED "HEAVY BLEEDING"; HOWEVER, IT WAS CONFIRMED THAT THE BLEEDING WAS NOT OUT OF CONTROL. THE SURGEON WAS ABLE TO CONTROL THE BLEEDING WITH AN UNSPE

  Patient problems: Blood Loss

  MAUDE report 10359931 ↗