EndoWrist 480322Recalls & reported problems

Summary

The FDA's MAUDE database contains 36 adverse event reports that list this exact device (DI 00886874112748), received between Feb 24, 2018 and Nov 13, 2020 — classified as 4 injuries, 32 malfunctions.

The most frequently reported specific device problem is “Failure to Deliver Energy” (28 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 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 36 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 13, 2020Material Fragmentation; Detachment of Device or Device Component; Material Fragmentation; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED GASTRIC BYPASS SURGICAL PROCEDURE, DURING THE REMOVAL OF THE VESSEL SEALER FROM THE PATIENT, THE SURGEON DID NOT COMPLETELY STRAIGHTEN THE INSTRUMENT WRIST PRIOR TO REMOVAL, RESULTING IN DAMAGE TO THE INSTRUMENT. FRAGMENTS FROM THE BROKEN VESSEL SEALER INSTRUMENT FELL INSIDE THE PATIENT ,AND ONLY SOME OF THE FRAGMENTS WERE RETRIEVED. THE PROCEDURE WAS COMPLETED WITH NO OTHER REPORTED ISSUES. 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: Foreign Body In Patient

  MAUDE report 10839726 ↗
• MalfunctionSep 30, 2019Failure to Deliver Energy; Failure to Deliver Energy

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE USER OBSERVED THAT ENERGY WAS UNABLE TO BE ACTIVATED ON THE VESSEL SEALER INSTRUMENT. THE USER COMPLETED THE PROCEDURE USING THE BACKUP INSTRUMENT WITH NO FURTHER ISSUE REPORTED. NO FRAGMENT FELL INSIDE THE PATIENT. NO KNOWN IMPACT OR PATIENT CONSEQUENCE WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9137674 ↗
• MalfunctionMar 19, 2019Difficult to Open or Close

  WHILE DOING A ROBOTIC RIGHT HEMICOLECTOMY FOR A MASS IN THE DISTAL ILEOCECAL VALVE WITH XI ROBOT, THE VESSEL SEALER JAWS WOULD NOT OPEN AND ANOTHER PRODUCT HAD TO BE UTILIZED.

  Patient problems: No Information

  MAUDE report 8436352 ↗
• MalfunctionNov 26, 2018Failure to Deliver Energy; Failure to Deliver Energy

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED TOTAL BENIGN HYSTERECTOMY PROCEDURE, THE VESSEL SEALER INSTRUMENT STOPPED SEALING. THERE WAS NO REPORT OF PATIENT HARM, ADVERSE OUTCOME OR INJURY. INTUITIVE SURGICAL, INC. (ISI) CONTACTED THE SITE AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION REGARDING: THE ROBOTICS COORDINATOR WAS NOT PRESENT DURING THE PROCEDURE BUT CONFIRMED NO PATIENT INJURY PER THE CASE NOTES.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8101889 ↗
• MalfunctionNov 20, 2018Failure to Deliver Energy; Failure to Deliver Energy

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SIGMOID COLECTOMY PROCEDURE, THE SURGICAL STAFF NOTED THAT THE VESSEL SEALER INSTRUMENT WAS NOT SEALING/CAUTERIZING TISSUE PROPERLY. THE SURGEON HAD DIFFICULTY SEALING THICKER TISSUE PROPERLY. THERE WAS NO REPORT OF FRAGMENTS FALLING INSIDE THE PATIENT. THERE WAS NO REPORT OF PATIENT HARM, ADVERSE OUTCOME OR INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE CUSTOMER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: A SECOND VESSEL SEALER INSTRUMENT WAS OPENED TO COMPLETE THE PROCEDURE ROBOTICALLY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8091716 ↗
• MalfunctionNov 14, 2018Failure to Deliver Energy; Failure to Deliver Energy

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SIGMOID COLECTOMY PROCEDURE, THE VESSEL SEALER INSTRUMENT WAS NOT WORKING. THE CUSTOMER WAS ABLE TO COMPLETE THE PROCEDURE 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: AN ERROR MESSAGE WAS DISPLAYED STATING THAT THE INSTRUMENT WAS NOT WORKING PROPERLY AND TO REMOVE AND REINSTALL THE INSTRUMENT. THE ERROR MESSAGE WAS NOT A PERSISTENT MESSAGE. ALTHOUGH, THE INSTRUMENT WAS REMOVED AND REINSTALLED, IT WOULD SOMETIMES CONTINUE TO FUNCTION PROPERLY. IT PROPERLY SEALED NUMEROUS TIMES THROUGHOUT THE CASE AND STILL WORKED A FEW TIMES AFTER THE ERROR MESSAGE HAD OCCURRED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8072072 ↗
• MalfunctionNov 13, 2018Failure to Deliver Energy; Failure to Deliver Energy

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED TOTAL COLECTOMY PROCEDURE, THE VESSEL SEALER INSTRUMENT WAS NOT SEALING PROPERLY. THE CUSTOMER STATED THAT AN INSUFFICIENT AMOUNT OF ENERGY WAS APPLIED TO THE INSTRUMENT TIPS. THE CUSTOMER STATED THAT THE "TISSUE BITES" WERE NOT LARGER THAN NORMAL AND THAT THE INSTRUMENT GAVE INDICATIONS THAT THE SEALING WAS COMPLETE BUT WAS NOT FULLY SEALING THE TISSUE. THE VESSEL SEALER INSTRUMENT WAS USED FOR APPROXIMATELY SEVEN FIRES BEFORE IT WAS SWAPPED OUT TO ANOTHER VESSEL SEALER INSTRUMENT. HOWEVER, THE ISSUE PERSISTED AND ONCE AGAIN THE INSTRUMENT WAS SWAPPED OUT. 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 PATIENT DID NOT EXPERIENCE ANY BLEEDING, AN ERROR MESSAGE WAS DISPLAYED BEFORE CUTTING, HOWEVER, IT IS UNKNOWN WHAT THE ERROR MESSAGE WAS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8067197 ↗
• MalfunctionNov 13, 2018Failure to Deliver Energy; Failure to Deliver Energy

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED TOTAL COLECTOMY PROCEDURE, THE VESSEL SEALER INSTRUMENT WAS NOT SEALING PROPERLY. THE CUSTOMER STATED THAT AN INSUFFICIENT AMOUNT OF ENERGY WAS APPLIED TO THE INSTRUMENT TIPS. THE CUSTOMER STATED THAT THE "TISSUE BITES" WERE NOT LARGER THAN NORMAL AND THAT THE INSTRUMENT GAVE INDICATIONS THAT THE SEALING WAS COMPLETE BUT WAS NOT FULLY SEALING THE TISSUE. THE VESSEL SEALER INSTRUMENT WAS USED FOR APPROXIMATELY SEVEN FIRES BEFORE IT WAS SWAPPED OUT TO ANOTHER VESSEL SEALER INSTRUMENT. HOWEVER, THE ISSUE PERSISTED AND ONCE AGAIN THE INSTRUMENT WAS SWAPPED OUT. 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 PATIENT DID NOT EXPERIENCE ANY BLEEDING, AN ERROR MESSAGE WAS DISPLAYED BEFORE CUTTING, HOWEVER, IT IS UNKNOWN WHAT THE ERROR MESSAGE WAS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8067196 ↗
• MalfunctionNov 2, 2018Failure to Deliver Energy; Failure to Deliver Energy

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SIGMOID COLECTOMY PROCEDURE, THE VESSEL SEALER INSTRUMENT DID NOT "SEAL COMPLETELY". THE CUSTOMER USED A VESSEL SEALER INSTRUMENT TO COMPLETE THE PROCEDURE. THERE WAS NO REPOT OF PATENT HARM, ADVERSE OUTCOME OR INJURY. ISI FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE ROBOTIC COORDINATOR (ROCO) CONFIRMED THAT DURING THE SEALING SEQUENCE, THE CUSTOMER HEARD AN AUDIBLE TONE, HOWEVER, DID NOT NOTE ANY ERROR MESSAGES. NO THERMAL EFFECT OR HEAT TRANSFER WAS NOTED AND THE TISSUE WAS NOT THICKER THAN NORMAL. THE ROCO CONFIRMED THERE WAS NO MEDICAL INTERVENTION REQUIRED. THE ROCO CONFIRMED THE PROCEDURE WAS COMPLETED AS PLANNED WITH NO PATIENT INJURY OR HARM.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8033875 ↗
• MalfunctionSep 27, 2018Failure to Deliver Energy; Failure to Deliver Energy

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE VESSEL SEALER INSTRUMENT DID NOT "SEAL EFFECTIVELY". PRIOR TO THE ISSUE BEING OBSERVED, THE INSTRUMENT HAD SUCCESSFULLY COMPLETED A SEAL FUNCTION. THE CUSTOMER STATED THAT THERMAL EFFECT ON THE TISSUE WAS OBSERVED; HOWEVER, NO AUDIBLE TONES OR ERROR MESSAGES WERE NOTED. NO OBSTRUCTIONS OR INTERFERENCES BETWEEN THE INSTRUMENT JAWS WAS NOTED. A BACK-UP VESSEL SEALER INSTRUMENT WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORT OF FRAGMENTS FALLING INSIDE THE PATIENT, PATIENT HARM, ADVERSE OUTCOME OR INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7915673 ↗
• MalfunctionSep 5, 2018Failure to Deliver Energy; Failure to Deliver Energy

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE VESSEL SEALER INSTRUMENT STOPPED WORKING. THERE WAS NO REPORT OF FRAGMENTS FALLING INSIDE THE PATIENT. THE PLANNED SURGICAL PROCEDURE WAS COMPLETED AND NO PATIENT HARM, ADVERSE OUTCOME, OR INJURY WAS REPORTED. INTUITIVE SURGICAL, INC. (ISI) CONTACTED THE SITE AND SPOKE TO THE CUSTOMER WHO PROVIDED THE FOLLOWING ADDITIONAL INFORMATION: THE DA VINCI COORDINATOR STATED THE VESSEL SEALER WAS WORKING FINE, BUT THEN IT STOPPED SEALING. THERE WERE NO ERROR CODES OR MESSAGES INDICATING THE INSTRUMENT WAS NOT SEALING. THE SURGEON WAS SEALING VESSELS AROUND THE COLON AND NOTICED HE WAS NOT SEEING ANY THERMAL EFFECT ON THE PATIENT¿S TISSUE (SMOKE). SHE DOESN¿T BELIEVE THE PATIENT HAD UNDERGONE ANY PRE-SURGICAL CHEMOTHERAPY OR RADIATION TREATMENTS. THE VESSEL SEALER INSTRUMENT DID NOT ENCOUNTER ANY STAPLES OR CLIPS DURING THE SEALING CYCLE. THE CUSTOMER USED ANOTHER VESSEL SEALER INSTRUMENT TO COMPLETE THE PROCEDURE AND THERE WAS NO INJURY TO THE PATIENT. THERE WAS NO VIDEO RECORDING DONE FOR THIS PROCEDURE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7849130 ↗
• InjuryAug 23, 2018Failure to Deliver Energy; Failure to Deliver Energy

  IT WAS INITIALLY REPORTED THAT DURING A DA VINCI-ASSISTED SIGMOID COLECTOMY PROCEDURE, THE SURGEON ATTEMPTED TO SEAL AN ARTERY AT THE PROXIMAL AND DISTAL ENDS USING AN ENDOWRIST VESSEL SEALER INSTRUMENT. THE SURGEON CLAIMED THAT THE INSTRUMENT FAILED TO SEAL AT BOTH LOCATIONS. ACCORDING TO THE INITIAL REPORTER, THERE WAS NO TENSION ON THE ARTERY AND THE SURGEON HAD CLEARED FAT FROM AROUND THE VESSEL. THE PATIENT LOST AN UNSPECIFIED AMOUNT OF BLOOD BUT THE SURGICAL STAFF WAS ABLE TO CONTROL THE BLEEDING. THE INITIAL REPORTER INDICATED THAT THE PATIENT WAS FINE. ON (B)(6) 2018, INTUITIVE SURGICAL, INC. (ISI) CONTACTED THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT: SHE WAS NOT PRESENT DURING THE SURGICAL PROCEDURE. THERE WERE NO REPORTED ERROR MESSAGES WHEN THE EVENT OCCURRED. THE INITIAL REPORTER DID NOT KNOW IF THE SURGEON SAW TISSUE EFFECT WHILE ATTEMPTING TO SEAL THE VESSEL IN QUESTION. THE INITIAL REPORTER INDICATED THAT THE ENDOWRIST VESSEL SEALER INSTRUMENT WAS WORKING AT THE BEGINNING OF THE SURGICAL PROCEDURE. WHEN THE EVENT OCCURRED, THE PATIENT LOST 900 ML OF BLOOD. HOWEVER, THE INITIAL REPORTER DID NOT KNOW WHAT SPECIFI

  Patient problems: Blood Loss

  MAUDE report 7811259 ↗
• MalfunctionAug 6, 2018Failure to Deliver Energy; Failure to Deliver Energy

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE ENDOWRIST VESSEL SEALER INSTRUMENT WOULD NOT SEAL. THERE WAS NO REPORT OF FRAGMENTS FALLING INSIDE THE PATIENT. THE PLANNED SURGICAL PROCEDURE WAS COMPLETED AND NO PATIENT HARM, ADVERSE OUTCOME, OR INJURY WAS REPORTED. INTUITIVE SURGICAL, INC. (ISI) CONTACTED THE SITE AND SPOKE TO THE CUSTOMER WHO PROVIDED THE FOLLOWING ADDITIONAL INFORMATION: THE CUSTOMER COULD NOT REMEMBER IF THERE WERE ANY ERROR MESSAGES OR ERROR CODES GENERATED. THEY COMPLETED THE CASE BY OPENING UP ANOTHER ENDOWRIST VESSEL SEALER.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7754332 ↗
• MalfunctionAug 3, 2018Break; Break

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED NISSEN FUNDOPLICATION PROCEDURE, IT WAS ALLEGED THAT ¿A SMALL PIECE OF DARK PLASTIC WAS FOUND ON TOP OF THE PATIENT¿S OMENTUM¿. THE ENDOWRIST VESSEL SEALER INSTRUMENT WAS THE ONLY INSTRUMENT THAT MATCHED THE COLOR OF THE FOREIGN BODY. THE FRAGMENT WAS RETRIEVED DURING THE SAME PROCEDURE WITH AN UNSPECIFIED LAPAROSCOPIC INSTRUMENT. HOWEVER, THE SITE IS NOT SURE IF THERE WERE ANY OTHER FRAGMENTS RETAINED INSIDE THE PATIENT. THERE WAS NO REPORT OF PATIENT HARM, ADVERSE OUTCOME OR INJURY. ON 10-JULY-2018, INTUITIVE SURGICAL, INC. (ISI) CONTACTED THE SURGEON AND GATHERED THE FOLLOWING ADDITIONAL INFORMATION: THE SURGEON WAS CAUTERIZING TISSUE FOR 45 MINUTES WITH ENDOWRIST VESSEL SEALER INSTRUMENT WHEN HE SAW A ¿PIECE OF DARK PLASTIC¿ ON THE OMENTUM. AT THAT TIME, HE REMOVED THE ENDOWRIST VESSEL SEALER INSTRUMENT AND RETRIEVED THE FRAGMENT WITH AN UNSPECIFIED LAPAROSCOPIC GRASPER. THE SURGEON CONFIRMED THE FOLLOWING; THERE WERE NO COLLISION OF INSTRUMENTS, THE WRISTS OF THE INSTRUMENTS WERE STRAIGHTENED WHEN REMOVED, AND THE INSTRUMENTS WERE INSPECTED PRIOR TO USE. THE SURGEON STATED THAT ¿TO THE BEST OF HIS HUMAN ABILITY HE LOOKED TO SEE I

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 7747946 ↗
• MalfunctionAug 1, 2018Failure to Deliver Energy; Failure to Deliver Energy

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED RIGHT HEMICOLECTOMY PROCEDURE, THE VESSEL SEALER INSTRUMENT INSUFFICIENTLY SEALED THE TISSUE. THE REPORTER ALSO NOTED THAT THE INSTRUMENT¿S JAWS DO NOT COMPLETELY CLOSE. THE INSTRUMENT WAS REPLACED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORT OF FRAGMENTS FALLING INSIDE THE PATIENT, PATIENT HARM, ADVERSE OUTCOME OR INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE ISI CLINICAL SALES REPRESENTATIVE (CSR) AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE CSR STATED THAT NO OUT OF THE ORDINARY BLEEDING OCCURRED DURING THE PROCEDURE. THE CUSTOMER WAS UNABLE TO SPECIFY IF THE SYSTEM DISPLAYED AN ERROR MESSAGE OR AN AUDIBLE BEEP. REVIEW OF THE EVENT LOGS VIA REMOTE FE CONDUCTED BY AN ISI FAILURE ANALYSIS ENGINEER INDICATED THAT THE VESSEL SEALER WAS USED ON THE EVENT DATE (B)(6) 2018 AND FOUND NO ERROR RELATED TO CUTTING OR SEALING.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7738838 ↗
• MalfunctionJul 25, 2018Output below Specifications

  DURING ROBOTIC LEFT COLECTOMY, THE LIGASURE DEVICE DID NOT BURN AS IT SHOULD HAVE WHEN THE HANDLE WAS DEPRESSED. DEVICE WOULD NOT SEAL. STAFF TRIED (WITHOUT EFFECTIVENESS) UNPLUGGING, CLEANING JAW, AND REGRASPING. A NEW DEVICE WAS RETRIEVED. THERE WAS NO HARM TO THE PATIENT. MANUFACTURER RESPONSE: FOR VESSEL SEALER, LIGASURE DEVICE, DAVINCI (PER SITE REPORTER). THE MANUFACTURER IS SENDING A REPLACEMENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7717701 ↗
• InjuryJul 19, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE SURGICAL STAFF ENCOUNTERED AN EXPOSED BLADE ISSUE WITH THE VESSEL SEALER INSTRUMENT AFTER A SYSTEM REBOOT. IT WAS INITIALLY REPORTED THAT THERE WAS PATIENT INJURY AND NO INSTRUMENT FRAGMENTS FELL INSIDE THE PATIENT. INTUITIVE SURGICAL, INC. (ISI) HAS MADE MULTIPLE ATTEMPTS TO CONTACT THE SITE TO OBTAIN ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT. HOWEVER, AS OF THE DATE OF THIS REPORT, NO ADDITIONAL INFORMATION HAS BEEN OBTAINED.

  Patient problems: Injury

  MAUDE report 7705462 ↗
• MalfunctionJul 17, 2018Material Fragmentation; Defective Device

  DAVINCI XI INSTRUMENT (VESSEL SEALER) WAS DEFECTIVE. INSTRUMENT MALFUNCTIONED DURING PROCEDURE CAUSING A FRAGMENT OF THE INSTRUMENT TO FALL INTO THE PT DURING THE PROCEDURE. FRAGMENT WAS RETRIEVED BY SURGEON; INSTRUMENT WAS REMOVED FROM FIELD AND GIVEN TO APPROPRIATE STAFF. INSTRUMENT BEING SENT BACK TO COMPANY FOR ANALYSIS PER COORDINATOR.

  Patient problems: Foreign Body In Patient

  MAUDE report 7697703 ↗
• MalfunctionJul 17, 2018Failure to Deliver Energy; Failure to Deliver Energy

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE VESSEL SEALER INSTRUMENT WOULD NOT ACTIVATE ENERGY. THERE WAS NO REPORT OF PATIENT HARM, ADVERSE OUTCOME OR INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE CUSTOMER AND WAS ABLE TO OBTAIN THE FOLLOWING ADDITIONAL INFORMATION: THE INSTRUMENT WAS WORKING AT THE START OF PROCEDURE BUT STOPPED SEALING APPROXIMATELY 30 MINUTES INTO THE PROCEDURE. THE CUSTOMER DID NOT TAKE NOTE OF THE ERROR MESSAGE BUT AUDIBLE TONES WERE HEARD DURING THE SEALING CYCLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7694597 ↗
• MalfunctionJul 10, 2018Failure to Deliver Energy; Failure to Deliver Energy

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED TOTAL BENIGN HYSTERECTOMY PROCEDURE, THE ENDOWRIST VESSEL SEALER INSTRUMENT WAS UNABLE TO MAKE A COMPLETE SEAL. THERE WAS NO REPORT OF FRAGMENTS FALLING INSIDE THE PATIENT. THE PLANNED SURGICAL PROCEDURE WAS COMPLETED AND NO PATIENT HARM, ADVERSE OUTCOME, OR INJURY WAS REPORTED. INTUITIVE SURGICAL, INC. (ISI) CONTACTED THE SITE AND SPOKE TO THE CUSTOMER WHO PROVIDED THE FOLLOWING ADDITIONAL INFORMATION: IT WAS REPORTED THAT THE ENDOWRIST VESSEL SEALER INSTRUMENT WAS WORKING INITIALLY, BUT IT WAS NEVER ABLE TO DO A COMPLETE SEAL. THE CUSTOMER CANNOT CONFIRM IF THERE WERE ANY ERROR MESSAGES OR IF THERE WAS AN AUDIO TONE WHEN THE ENDOWRIST VESSEL SEALER DID NOT SEAL. IT WAS CONFIRMED THAT THEY SWAPPED OUT TO A BACK-UP ENDOWRIST VESSEL SEALER INSTRUMENT AND COMPLETED THE PROCEDURE WITH NO FURTHER ISSUES.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7674867 ↗
• MalfunctionJul 9, 2018Failure to Deliver Energy; Failure to Deliver Energy

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED RIGHT HEMICOLECTOMY PROCEDURE, THE ENDOWRIST VESSEL SEALER INSTRUMENT SUDDENLY STOPPED WORKING. THE CUSTOMER REPORTED THAT THE INSTRUMENT WORKED FINE AT THE BEGINNING OF THE PROCEDURE AND THEN SUDDENLY STOPPED SEALING. THE CUSTOMER WAS UNABLE TO SPECIFY IF THE SYSTEM DISPLAYED AN ERROR MESSAGE. FOLLOWING THIS, A BACKUP VESSEL SEALER INSTRUMENT WAS INSERTED AND USED. THE PLANNED SURGICAL PROCEDURE WAS COMPLETED WITH NO FURTHER ISSUES REPORTED. THERE WAS NO REPORT OF FRAGMENTS FALLING INSIDE THE PATIENT, PATIENT HARM, ADVERSE OUTCOME OR INJURY. INTUITIVE SURGICAL, INC. (ISI) MADE MULTIPLE FOLLOW UP ATTEMPTS TO REACH THE CUSTOMER TO OBTAIN ADDITIONAL INFORMATION; HOWEVER, NO FURTHER INFORMATION HAD BEEN OBTAIN AS OF DATE OF THIS REPORT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7670201 ↗
• InjuryJul 6, 2018Failure to Deliver Energy; Failure to Deliver Energy

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SIGMOID COLECTOMY PROCEDURE, THE SURGEON ALLEGED THAT THE ENDOWRIST VESSEL SEALER INSTRUMENT "DID NOT SEAL¿ AND THE PATIENT EXPERIENCED BLEEDING. AS A RESULT, THE SURGEON PLACED SUTURES ON THE ARTERY TO CONTROL THE BLEEDING. ON 15-JUN-2018, THE INTUITIVE SURGICAL, INC. (ISI) CLINICAL SALES REPRESENTATIVE (CSR) WHO WAS PRESENT DURING THE PROCEDURE PROVIDED THE FOLLOWING ADDITIONAL DETAILS REGARDING THE REPORTED EVENT: IT WAS REPORTED THAT THE SURGEON WAS ABLE TO USE THE ENDOWRIST VESSEL SEALER INSTRUMENT WITHOUT ANY ISSUES UP UNTIL THE EVENT OCCURRED. THE SURGEON WAS ATTEMPTING TO SEAL THE PEDICLE OF THE INFERIOR MESENTERIC ARTERY (IMA) VESSEL. AFTER SEALING, THE SURGEON OBSERVED THAT THE STUMP APPEARED TO BE SHORT AND THEN BEGAN TO BLEED FROM THE STUMP. THE SURGEON WAS ABLE TO CONTROL THE BLEEDING BY PLACING SUTURES. ACCORDING TO THE CSR THE PATIENT EXPERIENCED UNSPECIFIED AMOUNT OF BLOOD LOSS; HOWEVER, IT WAS CONFIRMED THERE WAS NO BLOOD TRANSFUSION ADMINISTERED. THE CSR CONFIRMED THE FOLLOWING: THAT THEY HEARD THE AUDIBLE TONES INDICATING THAT THE SEALING CYCLE WAS COMPLETE, THE VESSEL WAS NOT CALCIFIED, AND NOT MORE THAN 7MM IN DIA

  Patient problems: Blood Loss

  MAUDE report 7667857 ↗
• MalfunctionJun 26, 2018Failure to Deliver Energy; Failure to Deliver Energy

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED BLADDER NECK SUSPENSION PROCEDURE, THE SURGEON NOTED THAT TWO VESSEL SEALER INSTRUMENTS WERE NOT CAUTERIZING. THE CUSTOMER INFORMED THE INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT THAT ALL INDICATORS OCCURRED WITH THE VESSEL SEALER BUT THERE WAS NO ENERGY. THE CUSTOMER CHECKED BOTH ENERGY PORTS FOR THE VESSEL SEALER WAS RECOMMENDED TO ATTEMPT THE VESSEL SEALER ON ANOTHER ARM. THE CUSTOMER MOVED THE VESSEL SEALER TO ARM #2 AND THE INSTRUMENT ENERGIZED WHEN ACTIVATED. THEN REQUESTED THE CUSTOMER TO RESEAT THE STERILE ADAPTER ON ARM #4 AND ATTEMPT THE VESSEL SEALER AGAIN. THE VESSEL SEALER ENERGY ACTIVATED ON ARM #4 AFTER THE STERILE ADAPTER WAS RESEATED. THE PLANNED SURGICAL PROCEDURE WAS COMPLETED AND THERE WAS NO REPORT OF ANY PATIENT HARM, ADVERSE OUTCOME OR INJURY. ON 12-JUN-2018, ISI RECEIVED ADDITIONAL INFORMATION FROM THE ISI CLINICAL SALES REPRESENTATIVE (CSR) WHO INITIALLY REPORTED THIS COMPLAINT: THE ISI CSR INDICATED THAT SHE WAS UNSURE WHETHER THEY HEARD THE AUDIBLE TONES AND NO THERMAL EFFECT WAS NOTED ON THE TISSUE. THERE WERE NO ERROR MESSAGES WHEN THE GRIPS WERE OPENED AND IT WAS NOTICED THAT NO ENERGY WAS GENERATED

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7639402 ↗
• MalfunctionJun 26, 2018Failure to Deliver Energy; Failure to Deliver Energy

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED BLADDER NECK SUSPENSION PROCEDURE, THE SURGEON NOTED THAT TWO VESSEL SEALER INSTRUMENTS WERE NOT CAUTERIZING. THE CUSTOMER INFORMED THE INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT THAT ALL INDICATORS OCCURRED WITH THE VESSEL SEALER BUT THERE WAS NO ENERGY. THE CUSTOMER CHECKED BOTH ENERGY PORTS FOR THE VESSEL SEALER WAS RECOMMENDED TO ATTEMPT THE VESSEL SEALER ON ANOTHER ARM. THE CUSTOMER MOVED THE VESSEL SEALER TO ARM #2 AND THE INSTRUMENT ENERGIZED WHEN ACTIVATED. THEN REQUESTED THE CUSTOMER TO RESEAT THE STERILE ADAPTER ON ARM #4 AND ATTEMPT THE VESSEL SEALER AGAIN. THE VESSEL SEALER ENERGY ACTIVATED ON ARM #4 AFTER THE STERILE ADAPTER WAS RESEATED. THE PLANNED SURGICAL PROCEDURE WAS COMPLETED AND THERE WAS NO REPORT OF ANY PATIENT HARM, ADVERSE OUTCOME OR INJURY. ON 12-JUN-2018, ISI RECEIVED ADDITIONAL INFORMATION FROM THE ISI CLINICAL SALES REPRESENTATIVE (CSR) WHO INITIALLY REPORTED THIS COMPLAINT: THE ISI CSR INDICATED THAT SHE WAS UNSURE WHETHER THEY HEARD THE AUDIBLE TONES AND NO THERMAL EFFECT WAS NOTED ON THE TISSUE. THERE WERE NO ERROR MESSAGES WHEN THE GRIPS WERE OPENED AND IT WAS NOTICED THAT NO ENERGY WAS GENERATED

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7639398 ↗
• InjuryJun 14, 2018Failure to Deliver Energy; Failure to Deliver Energy

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED THYMECTOMY PROCEDURE, THE SURGICAL STAFF OBSERVED BLEEDING WHILE USING THE VESSEL SEALER INSTRUMENT "AT THE BRANCHED PART OF THE RIGHT ARM HEAD VEIN." DURING THE EVENT, THE AUDIBLE TONES INDICATING THAT THE SEALING CYCLE WAS COMPLETE, WERE REPORTEDLY HEARD. WHEN THE SURGEON OPENED THE JAWS OF THE VESSEL SEALER INSTRUMENT, BLEEDING WAS CONFIRMED. ACCORDING TO THE INITIAL REPORTER, "HEMOSTASIS WAS COMPLETED WITH BIPOLAR SOFT COAGULATION OF ERBE VI0 DV." ON AN UNSPECIFIED DATE/TIME POST-OPERATIVELY, THE COLOR OF AN UNSPECIFIED DRAIN WAS ALLEGEDLY FOUND TO BE "TOO THICK (DARK)". AS A RESULT, THE PATIENT UNDERWENT A VATS PROCEDURE AND THE AREA WHERE THE VESSEL SEALER INSTRUMENT WAS USED WAS CAUTERIZED WITH AN UNSPECIFIED BIPOLAR DEVICE.

  Patient problems: Blood Loss

  MAUDE report 7604031 ↗