None 470361Recalls & reported problems

Summary

The FDA's MAUDE database contains 27 adverse event reports that list this exact device (DI 00886874112540), received between Dec 17, 2019 and May 9, 2026 — classified as 14 injuries, 13 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (12 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 27 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 9, 2026Gas/Air Leak

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, AIR LEAKAGE OCCURRED WITH THE UNIVERSAL SEAL. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25133168 ↗
• MalfunctionFeb 11, 2025Detachment of Device or Device Component; Material Split, Cut or Torn; Detachment of Device or Device Component; Material Split, Cut or Torn

  ON 01/15/2025, INTUITIVE SURGICAL, INC. (ISI) RECEIVED USER FACILITY REPORT MW5164094 STATING: THE INNER CANNULA OF THE TROCAR CAME APART DURING SURGERY. ISI CONTACTED THE INITIALS REPORTER AND OBTAINED THE FOLLOWING INFORMATION: THE BROKEN PIECE WAS VISUALIZED THROUGH THE CAMERA WHILE THE PROCEDURE WAS BEING PERFORMED AND WAS RETRIEVED. THE FRAGMENT WAS COLLECTED INTO THE ENDO CATCH BAG. THERE WERE NO REPORTS OF PATIENT INJURY, AND THE PROCEDURE WAS COMPLETED ROBOTICALLY. THERE WAS NO DELAY TO THE PROCEDURE.

  Patient problems: Insufficient Information

  MAUDE report 21352433 ↗
• MalfunctionNov 27, 2024Gas/Air Leak; Gas/Air Leak

  REFER TO H11 FOR FOLLOW-UP INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20801359 ↗
• MalfunctionNov 1, 2024Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE CANNULA SEAL CAUSED AIR LEAKAGE. 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 DURING THE PROCEDURE. THE INSUFFLATION VALVE WAS LOOSE, AND INSUFFLATION WAS LOST COMPLETELY. THE LOSS OF INSUFFLATION DID NOT PRESENT ANY ISSUES/CHALLENGES LIKE REDUCED VISUALIZATION, TISSUE INJURY, OR PROCEDURE DELAY > 30 MINUTES. THE ISSUE WAS RESOLVED AFTER REPLACING A NEW SEALING CAP.

  Patient problems: Insufficient Information

  MAUDE report 20592332 ↗
• MalfunctionOct 29, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  REFER TO H11 FOR FOLLOW-UP INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20553938 ↗
• InjurySep 19, 2024Material Fragmentation; Material Fragmentation

  REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.

  Patient problems: Foreign Body In Patient

  MAUDE report 20260170 ↗
• MalfunctionJul 24, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE THE CANNULA SEAL ACCESSORY WAS TOO TIGHT THAT IT GOT STUCKED THE HARMONIC ACE. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. ON 7/17/2024, ISI FOLLOWED UP WITH THE CUSTOMER AND GATHERED THE FOLLOWING INFORMATION: THE INSTRUMENT AND CANNULA DID NOT NEED TO BE REMOVED TOGETHER BUT THE CUSTOMER TRIED SO HARD TO REMOVE IT AND SPENT A LOT OF TIME. THERE WAS A PIN STICKING OUT. NO FRAGMENT FELL INSIDE THE PATIENT. PORT INCISION SIZE WAS NOT INCREASED. THE INSTRUMENT WAS INSPECTED PRIOR TO USE AND APPEARED NORMAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19813610 ↗
• InjuryJul 15, 2024Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE WHILE INSERTING AN INSTRUMENT, THE BLUE PIECE ON THE INSIDE OF THE CANNULA SEAL HAD A LITTLE PIECE BREAK OFF INTO THE PATIENT. IT WAS RETRIEVED DURING THE SAME PROCEDURE. THE PROCEDURE WAS COMPLETED WITHOUT DELAY.

  Patient problems: Foreign Body In Patient

  MAUDE report 19745204 ↗
• MalfunctionMar 19, 2024Gas/Air Leak; Gas/Air Leak

  REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18927682 ↗
• InjuryJan 23, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.

  Patient problems: Foreign Body In Patient

  MAUDE report 18567398 ↗
• InjuryJan 19, 2024Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED UNILATERAL INGUINAL HERNIA PROCEDURE, THE CANNULA SEAL ACCESSORY RIPPED WHILE THE CUSTOMER WAS INSERTING MESH INSIDE THE PATIENT WITH A GRASPER INSTRUMENT. DURING INSERTION OF THE GRASPER, THE CUSTOMER SAW A BLUE FRAGMENT/PIECE INSIDE THE PATIENT. THE CANNULA SEAL WAS INSPECTED, AND IT WAS NOTED TO BE TORN. IT IS UNKNOWN IF THERE WAS AN INSTRUMENT/ACCESSORY COLLISION. THE INSTRUMENT WRIST WAS STRAIGHTENED DURING REMOVAL. THE FRAGMENT WAS RETRIEVED USING A BACK-UP INSTRUMENT DURING THE SAME PROCEDURE WHICH WAS COMPLETED ROBOTICALLY. THERE ARE NO PHOTOGRAPHIC IMAGES AVAILABLE.

  Patient problems: Foreign Body In Patient

  MAUDE report 18545477 ↗
• MalfunctionSep 7, 2023Gas/Air Leak; Gas/Air Leak

  REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17704320 ↗
• MalfunctionAug 4, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17465744 ↗
• InjuryJun 5, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED GASTRIC BYPASS SURGICAL PROCEDURE, THE CUSTOMER WAS PUTTING THE CAMERA IN WHEN THEY SAW A PIECE OF THE BLUE CANNULA SEAL HAD FALLEN INTO THE PATIENT. THE CUSTOMER RETRIEVED THE FRAGMENT WITH A BACKUP INSTRUMENT. THE FRAGMENT DID NOT FALL INTO THE PATIENT DURING AN INSTRUMENT TIP/ACCESSORY COLLISION. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: ALL FRAGMENTS WERE RETRIEVED. NO OTHER PIECES WERE OBSERVED TO FALL INTO THE PATIENT AND NO PIECES WERE NOTICED THROUGHOUT THE DURATION OF THE PROCEDURE. THERE WAS NO ADDITIONAL SURGICAL PROCEDURE REQUIRED TO REMOVE THE FRAGMENT AND THERE WAS NO POST-OPERATIVE TESTS LIKE AN X-RAY OR ULTRASOUND PERFORMED TO CHECK FOR REMAINING FRAGMENTS. THE SURGEON FELT THAT THE FRAGMENT BROKE FROM THE CANNULA SEAL, BUT THE CUSTOMER WAS UNABLE TO FIND A SIMILAR PART ON AN UNALTERED SEAL. THE FRAGMENT WAS NOTICED AS SOON AS THE CAMERA WAS INTRODUCED INTO THE ABDOMEN. THE CANNULA SEAL WAS INSPECTED VISUALLY PRIOR TO START OF PROCEDURE AND HAD NO DAMAGE NOTED. THE SURGICAL STAFF DID NOT FEEL ANY RESISTANCE UPON REMOVAL OF THE INSTRUMENT THRO

  Patient problems: Foreign Body In Patient

  MAUDE report 17065176 ↗
• MalfunctionJun 1, 2023Positioning Failure; Loose or Intermittent Connection

  2 OF THE 4 CANNULA SEALS THAT OPEN/CLOSE THE CO2 FLOW WERE VERY LOOSE AND NOT REMAINING IN THE POSITION REQUIRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17037901 ↗
• InjuryMay 22, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE FRAGMENTS OF THE CANNULA OR CANNULA SEAL FELL INTO THE CAVITY OF THE PATIENT. THE DEFECTIVE PRODUCT WAS FROM ANOTHER COMPANY, THEREFORE NO PRODUCT IS BEING RETURNED. THERE WAS NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE CANNULA SEAL HAD NO PHYSICAL DAMAGE. THE FRAGMENT THAT FELL INTO THE PATIENT WAS CONFIRMED TO BE A THIRD-PARTY PRODUCT. IT WAS UNKNOWN WHAT THE CAUSE OF THE FRAGMENT FALLING INTO THE PATIENT. IT WAS ALSO NOTED THAT IT WAS UNKNOWN IF THE FRAGMENT WAS RETRIEVED AND IF POST-OPERATIVE TESTS WERE PERFORMED.

  Patient problems: Foreign Body In Patient

  MAUDE report 16973209 ↗
• InjuryMay 13, 2023Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED LOW ANTERIOR RESECTION SURGICAL PROCEDURE, A PIECE OF THE CANNULA SEAL WAS DETACHED AND FELL INSIDE THE PATIENT. THE PIECE WAS FOUND AND RETRIEVED. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. INFORMATION ON PATIENT DEMOGRAPHIC AND RELATED INFORMATION (RELEVANT TESTS, RELEVANT PATIENT HISTORY, INCLUDING PRE-EXISTING MEDICAL CONDITIONS) WAS REQUESTED; HOWEVER, THE SITE INDICATED THAT PATIENT RELATED INFORMATION COULD NOT BE PROVIDED/ COULD NOT BE RELEASED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16928165 ↗
• InjuryMay 12, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED DURING A DA VINCI-ASSISTED CHOLECYSTECTOMY, A FRAGMENT OF THE 5-8MM CANNULA SEAL WAS FOUND INSIDE THE PATIENT. THE FRAGMENT WAS RETRIEVED WITH NO OTHER PATIENT INJURY REPORTED. THE PROCEDURE WAS COMPLETED ROBOTICALLY. THE SURGEON WAS DISSECTING THE CYSTIC DUCT, AND THE ISSUE OCCURRED DURING THE CLIP APPLICATION OF THE PROXIMAL END OF THE CYSTIC DUCT. THE SURGEON REPORTED THAT DURING THE SECOND OR THE THIRD INSTALLATION OF THE FIRST MEDIUM-LARGE CLIP APPLIER INSTRUMENT INTO THE CANNULA, THE INSTRUMENT WAS STUCK ON THE DIAPHRAGM OF THE CANNULA SEAL AND WAS DESCRIBED LIKE "BOUNCING ON A TRAMPOLINE" AND WON'T PASS THROUGH THE CANNULA. A 5MM LAPAROSCOPIC NON-DA VINCI INSTRUMENT WAS ATTEMPTED TO PASS THROUGH THE SAME CANNULA, AND WAS ABLE TO PASS THROUGH WITHOUT ANY ISSUE. THE CLIP APPLIER INSTRUMENT WAS VISUALLY INSPECTED WITH NO PHYSICAL DAMAGE OR MISALIGNMENT IDENTIFIED, AND THE CLIPS WERE INSTALLED CORRECTLY, WITH NO BEND OR ABNORMALITY NOTED. THE JAW OF THE CLIP APPLIER INSTRUMENT WAS SLIGHTLY CLOSE UP TO PASS THROUGH THE DIAPHRAGM AS USUAL. AFTER APPLYING A LITTLE BIT MORE FORCE THAN HOW THE SURGEON NORMALLY DOES WHILE INSTALLING, THE CLIP APPLIER INSTRUMENT WENT TH

  Patient problems: Foreign Body In Patient

  MAUDE report 16919332 ↗
• InjuryDec 5, 2022Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED THORACIC SURGICAL PROCEDURE, THE CUSTOMER REPORTED THAT A BLUE RUBBER OBJECT WAS FOUND INSIDE THE PATIENT¿S ANATOMY WHEN THE ENDOSCOPE WAS INSERTED INTO THE BODY CAVITY. THE SURGEON WAS PERFORMING MEDIASTINAL TUMOR RESECTION. THE CUSTOMER STATED THAT THERE WAS A FOREIGN OBJECT INSIDE THE CANNULA SEAL BEFORE THE ISSUE OCCURRED. WHEN THE ENDOSCOPE WAS INSERTED, THE OBJECT WAS PUSHED OUT AND FELL INTO THE CHEST CAVITY. THE OBJECT WAS RETRIEVED IN THE SAME PROCEDURE. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY WITH A BACKUP SEAL. ISI FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE INSTRUMENT AND ACCESSORY WERE VISUALLY CHECKED PRIOR TO USE WITH NO ISSUE. THE OBJECT WAS RETRIEVED WITH THE VIDEO-ASSISTED THORACOSCOPIC SURGERY (VATS) FORCEPS. IT WAS CONFIRMED THAT ALL FRAGMENTS WERE RETRIEVED. NO ADDITIONAL SURGICAL PROCEDURE WAS REQUIRED TO REMOVE THE OBJECT. NO POST-OPERATIVE TEST WAS PERFORMED. THE PROCEDURE WAS COMPLETED ROBOTICALLY WITH NO PATIENT¿S INJURY. THE PATIENT DID NOT RETURN TO THE HOSPITAL FOR ANY POST-SURGICAL COMPLICATIONS RELATED TO RETAINING A FOREIGN OBJECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15921662 ↗
• InjuryOct 2, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SIMPLE PROSTATECTOMY SURGICAL PROCEDURE, A PIECE OF THE CANNULA SEAL FELL INTO THE PATIENT. THE BROKEN PIECE WAS RETRIEVED WITH A BACKUP INSTRUMENT AND IT IS AVAILABLE FOR RETURN. THE CANNULA SEAL WAS BROKEN WHILE PLACING INSIDE THE PATIENT. THE ISSUE WAS RESOLVED BY USING A BACKUP CANNULA SEAL. 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 ON 15-SEPT-2022: ALL FRAGMENTS WERE RETRIEVED. THERE WAS NO ADDITIONAL SURGICAL PROCEDURE REQUIRED TO REMOVE THE FRAGMENT. THERE WERE NO POST-OPERATIVE TESTS LIKE AN X-RAY OR ULTRASOUND PERFORMED TO CHECK FOR REMAINING FRAGMENTS. THE SURGEON BELIEVED THAT IT WAS ACTUALLY A PIECE OF SURGICAL GLOVE USED BY THE STERILE PROCESSING DEPARTMENT (SPD) IN THE REPROCESSING AREA AND THAT A PIECE OF THE GLOVE FOUND ITS WAY IN THE CANNULA. THE CANNULA SEAL LOOKED COMPLETELY INTACT. THE CUSTOMER HAS JUST STARTED THE PROCEDURE WHEN THE ISSUE OCCURRED. THE CANNULA SEAL WAS NOT INSPECTED PRIOR TO USE BUT WAS INSPECTED AFTERWARDS. THE SURGEON DID NOT NOTICE ISSUES WITH THE FUNCTIONAL

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 15526116 ↗
• MalfunctionJun 30, 2022Loose or Intermittent Connection; Loose or Intermittent Connection

  IT WAS REPORTED TO INTUITIVE SURGICAL, INC. (ISI) COMPLAINTS FROM SURGEONS/STAFF AT MORE THAN 1 HOSPITAL ABOUT THE STOPCOCK SWITCH ON THE XI CANNULA SEALS BEING SO LOOSE THEY RANDOMLY WILL MOVE, EITHER ALLOWING GAS TO ESCAPE OR SHUTTING OFF THE INSUFFLATION TO THE ABDOMEN. UPON INSPECTION BY THE CUSTOMER, THE XI CANNULA SEALS WERE NOTED TO BE VERY LOOSE, AND THE SMALLEST MOVEMENT BY THE INSTRUMENT ARM WILL CAUSE THIS TO HAPPEN. REPORTEDLY, THIS HAS OCCURRED WHILE THE SURGEON IS WORKING, THEN THE PATIENT¿S ABDOMEN QUICKLY LOSES GAS WITH INSTRUMENTS IN. IT IS UNKNOWN WHETHER ANY SERIOUS INJURY TO THE PATIENT HAS OCCURRED DUE TO ABDOMEN QUICKLY LOSING GAS DURING THE PROCEDURES.

  Patient problems: Insufficient Information

  MAUDE report 14876504 ↗
• InjuryMar 20, 2022Detachment 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 FOUND A PLASTIC PIECE INSIDE THE PATIENT. THE PIECE WAS RETRIEVED DURING THE SAME PROCEDURE. THE SURGEON BELIEVED THE PIECE CAME FROM ONE OF THE CANNULA SEALS (THERE WERE FOUR CANNULA SEALS IN USE DURING THE PROCEDURE). THE PROCEDURE WAS COMPLETED WITH NO INJURY TO THE PATIENT. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER (NURSE) AND OBTAINED ADDITIONAL INFORMATION: THE BROKEN PIECE WAS RETRIEVED USING A GRASPER. THE FRAGMENT WAS RETRIEVED, AND IT WAS VISUALLY CONFIRMED. THE CANNULA SEAL WAS INSPECTED PRIOR TO USE AND NO DAMAGE WAS NOTED. THE CANNULA SEAL WAS IN USE FOR 45 MINUTES PRIOR TO THE REPORTED ISSUE. THE BROKEN FRAGMENT WAS NOTED WHEN THE SURGEON WAS GRASPING THE TISSUE. THE SURGEON DID NOT NOTICE ANY ISSUES WITH THE FUNCTIONALITY OF THE CANNULA SEAL AND DID NOT ENCOUNTER ANY COLLISION DURING THE SURGICAL PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13834468 ↗
• MalfunctionOct 5, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.

  Patient problems: Foreign Body In Patient; Insufficient Information

  MAUDE report 12573977 ↗
• InjuryJun 11, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11987078 ↗
• InjurySep 4, 2020Break; Break

  REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 10497869 ↗