None 470380Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00886874112571), received between Jul 22, 2021 and Jun 7, 2023 — classified as 3 injuries.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (2 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryJun 7, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED LOW ANTERIOR RESECTION (LAR) SURGICAL PROCEDURE, A FRAGMENT OF THE CANNULA SEAL FELL INTO THE PATIENT¿S ANATOMY. THE FRAGMENT WAS A RESULT OF A PORTION OF THE CANNULA SEAL VALVE BEING BROKEN OFF. THE CUSTOMER CONFIRMED THAT THE FRAGMENT WAS REMOVED DURING THE SAME PROCEDURE, AND NO MORE RESIDUE WAS LEFT INSIDE THE PATIENT¿S ANATOMY. 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 CANNULA SEAL WAS NOT INSPECTED PRIOR TO USE SINCE IT IS A DISPOSABLE PRODUCT. THE CANNULA SEAL DID NOT COLLIDE WITH ANY OTHER INSTRUMENT OR HARD MATERIAL DURING THE SURGICAL PROCEDURE. THE FRAGMENT WAS RETRIEVED BY USING THE OTHER INSTRUMENT DURING THE SAME PROCEDURE. VISUAL INSPECTION CONFIRMED THAT ALL FRAGMENTS WERE RETRIEVED. NO ADDITIONAL PROCEDURE WAS REQUIRED TO REMOVE THE FRAGMENT. NO POST-OPERATIVE TESTS WERE PERFORMED. THE PROCEDURE WAS COMPLETED ROBOTICALLY WITH NO PATIENT INJURY. THE PATIENT DID NOT RETURN TO THE HOSPITAL DUE TO ANY POST-SURGICAL COMPLICATIONS.

  Patient problems: Foreign Body In Patient

  MAUDE report 17079941 ↗
• InjuryMay 13, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED APPENDECTOMY SURGICAL PROCEDURE, THE CUSTOMER INFORMED THE TECHNICAL SERVICE ENGINEER (TSE) THAT THE SURGEON WANTED TO DISCUSS A BROKEN PIECE THAT WAS FOUND. THE SURGEON LATER CALLED INTO TECHNICAL SUPPORT AND STATED THEY WERE USING A 12MM SEAL WITH AN 8MM REDUCER AND BELIEVED THEY FOUND ALL THE PIECES, BUT NEEDED TO CONFIRM IF THE SEAL WAS RADIOPAQUE. THE SURGEON WOULD PROVIDE PICTURES. THE FIELD SERVICE ENGINEER (FSE) FOLLOWED UP WITH THE SURGEON WHO INFORMED THAT HE WAS ABLE TO COMPARE THE DAMAGED SEAL WITH THE NEW ONE AND BELIEVED THAT THEY HAD ALL THE PART. THE SURGEON WAS GOING TO PERFORM AN X-RAY AS A PRECAUTION. THE PROCEDURE WAS COMPLETING AS PLANNED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE SURGEON AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE SURGEON CONFIRMED THE PROCEDURE WAS A ROBOTIC ASSISTED APPENDECTOMY. IT WAS NOTED THAT THERE IS NO TRAINING FOR EXAMINATION OF THE DISPOSABLE ACCESSORY; HOWEVER, THE STAFF DOES LOOK AT THE EXTERIOR OF THE ACCESSORY PRIOR TO INSTALLING. THE SURGEON INFORMED THAT THE SEAL WAS INSTALLED FOR APPROXIMATELY 20 MINUTES PRIOR TO THE ISSUE OCCURRING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16925236 ↗
• InjuryJul 22, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  DURING A DA VINCI-ASSISTED BARIATRIC REVISION SURGICAL PROCEDURE, IT WAS REPORTED THAT THE STAPLER INSTRUMENT WAS NOT PASSING THROUGH THE CANNULA WELL. THE CUSTOMER STATED THAT THE BLUE GUM BROKE OFF OF THE STAPLER CANNULA SEAL AND FELL INTO THE PATIENT. THE FRAGMENT WAS RETRIEVED DURING THE SAME SURGERY USING A LAPAROSCOPIC INSTRUMENT. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. INTUITIVE SURGICAL (IS) CONTACTED THE SITE AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION ON 06-JULY-2021: THE STAPLER INSTRUMENT WAS INSPECTED PRIOR TO USE AND NO DAMAGE WAS OBSERVED. THE INSTRUMENT WAS USED DURING THE ENTIRE SURGERY WITH NO NOTED ISSUES REGARDING THE FUNCTIONALITY. THE INSTRUMENT WAS REMOVED DURING THE PROCEDURE AND THE WRIST WAS STRAIGHTENED PRIOR TO REMOVAL. RESISTANCE WAS FELT UPON REMOVAL OF THE INSTRUMENT THROUGH THE CANNULA, BUT AFTER REMOVAL, NO DAMAGE WAS OBSERVED EITHER ON THE INSTRUMENT OR ANY OTHER COMPONENT. THE INCIDENT WITH THE PIECE BREAKING OFF OF THE STAPLER CANNULA SEAL OCCURRED WHEN RE-INSERTING THE INSTRUMENT, NEAR THE END OF THE PROCEDURE. THE CUSTOMER STATED THAT THEY SUSPECTED THAT IT WAS DUE TO THE STAPLER SHEATH BUT NO DETAILS WERE NOTED AS TO WHY. IT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12215409 ↗