Single-Site 478058Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00886874113622), received between Jun 22, 2017 and Mar 13, 2025 — classified as 4 injuries, 1 malfunction.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (3 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryMar 13, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE CONNECTING PART OF THE FUNDUS GRASPER TIP WAS BROKEN, AND A FRAGMENT FELL INTO THE PATIENT. THE FRAGMENT WAS REMOVED DURING THE SAME PROCEDURE. THE PROCEDURE WAS COMPLETED. 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 SURGICAL TASK BEING PERFORMED WHEN THE DEVICE FRAGMENT FELL INTO THE PATIENT WAS INSTRUMENT REMOVAL. IT IS UNKNOWN WHAT THE SURGEON BELIEVES WAS THE CAUSE OF THE INSTRUMENT BREAKAGE. THE INSTRUMENT WAS IN USE FOR ABOUT 15 TO 20 MINUTES. THE SURGEON DID NOT NOTICE ANY ISSUE WITH THE FUNCTIONALITY OF THE INSTRUMENT DURING THE PROCEDURE PRIOR TO THE BREAKAGE. THE INSTRUMENT DID NOT COLLIDE WITH ANY OTHER INSTRUMENTS OR OTHER HARD MATERIALS DURING THE SURGICAL PROCEDURE. THE FRAGMENT DID NOT FALL INSIDE THE PATIENT DURING AN INSTRUMENT TIP COLLISION. THE INSTRUMENT WAS NOT REMOVED DURING THE SURGICAL PROCEDURE PRIOR TO THE BREAKAGE. UPON FINAL REMOVAL OF THE INSTRUMENT, THE WRIST WAS STRAIGHTENED. THE STAFF DID NOT FEEL ANY RESISTANCE UPON THE FINAL REMOVAL

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21593133 ↗
• InjuryMay 13, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED CHOLECYSTECTOMY SURGICAL PROCEDURE, THE DOCTOR GRASPED THE GALLBLADDER AND AS HE WAS RETRACTING THE GALLBLADDER UP OVER THE LIVER, THE FUNDUS GRASPER INSTRUMENT FELL APART. IT WAS NOTED THAT ONE JAW FELL INTO THE ABDOMEN AND THE OTHER JAW WAS VERY LOOSE AND FLOPPY. AN ENDOPOUCH WAS INTRODUCED INTO THE ABDOMEN SO THAT THE BROKEN PART COULD BE REMOVED SAFELY AND THE FUNDUS GRASPER INSTRUMENT WITH THE FLOPPY JAWS WAS WATCHED OUT WITH THE CAMERA AS IT WAS CAREFULLY REMOVED. AN X-RAY WAS TAKEN AND NOTHING WAS FOUND TO BE LEFT BEHIND. 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 INFORMED THAT THE BELOW INFORMATION WAS GIVEN TO HER FROM THE SURGEON AS SHE ONLY WALKED INTO THE CASE AFTER THE FRAGMENT HAD FALLEN INTO THE PATIENT. THE ROBOTIC COORDINATOR INFORMED THAT SHE WAS UNAWARE IF THE FUNDUS GRASPER INSTRUMENT WAS INSPECTED PRIOR TO USE. AT THE TIME OF THE REPORTED ISSUE, IT WAS STATED THAT THE SURGEON HAD JUST PLACED THE INSTRUMENT INTO THE SYSTEM AND HAD GRASPED THE GALLBLADDER WHEN T

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16928208 ↗
• InjuryMar 20, 2023Entrapment of Device; Difficult to Open or Close; Entrapment of Device; Difficult to Open or Close

  IT WAS REPORTED THAT DURING A DAVINCI-ASSISTED CHOLECYSTECTOMY SURGICAL PROCEDURE, THE FUNDUS GRASPER JAWS WOULD NOT RELEASE FROM THE GALLBLADDER. THE EMERGENCY STOP BUTTON WAS PRESSED, AND THE SITE ATTEMPTED TO REMOVE THE INSTRUMENT VIA THE INSTRUMENT RELEASE KIT. THE KIT DID NOT SUCCESSFULLY OPEN THE INSTRUMENT'S JAWS, AND A SECOND KIT WAS USED, ALSO UNSUCCESSFULLY. THE SURGEON DECIDED TO CUT THE TISSUE AROUND THE INSTRUMENT TO REMOVE IT FROM THE PATIENT AND THEN CONTINUE THE PROCEDURE WITH ONE UNIVERSAL SURGICAL MANIPULATOR (USM). THE SITE CONTACTED A TECHNICAL SUPPORT ENGINEER (TSE) AT THE TIME OF THE EVENT, AND AFTER GUIDING THE STAFF THROUGH THE USE OF THE RELEASE KIT THE SECOND TIME AND INFORMING THEM THAT REBOOTING THE SYSTEM WOULD NOT RESOLVE THE PROBLEM, THE TSE ADVISED THE STAFF THAT THE SURGEON "WOULD HAVE TO DETERMINE THE BEST WAY TO PROCEED." THE INSTRUMENT WAS INSTALLED ON USM 3. THE PROCEDURE WAS COMPLETED, WITH NO OTHER REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) CONTACTED THE SURGEON FOR THE PROCEDURE, AND THE FOLLOWING ADDITIONAL INFORMATION WAS OBTAINED: THE SURGEON STATED THAT THE INSTRUMENT WAS GRASPING THE TOP OF THE FUNDUS AT THE TIME OF THE EVENT, AND H

  Patient problems: Unspecified Tissue Injury

  MAUDE report 16572187 ↗
• MalfunctionFeb 10, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED CHOLECYSTECTOMY SURGICAL PROCEDURE, THE FUNDUS GRASPER INSTRUMENT HAD BROKEN JAWS. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. AN INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: AT THE END OF THE PROCEDURE THE FUNDUS GRASPER INSTRUMENT GOT CAUGHT AT THE CANNULA AND THE CUSTOMER USED FORCE TO PULL IT OUT. THE INSTRUMENT JAWS WERE BROKEN AND UNKNOWN IF IT WAS INTEROPERATIVE OR BROKE WHILE BEING DOCKED. THE INSTRUMENT WAS INSPECTED PRIOR TO USE. THE INSTRUMENT WAS THOROUGHLY CHECKED, AND ALL PIECES WERE PRESENT, NO FRAGMENTS FELL INTO THE PATIENT. THERE WAS NO HARM OR INJURY TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16354427 ↗
• InjuryJun 22, 2017Break; Device Or Device Fragments Location Unknown; Break; Device Or Device Fragments Location Unknown

  IT WAS REPORTED THAT DURING A SINGLE-SITE DA VINCI-ASSISTED CHOLECYSTECTOMY PROCEDURE, THE JAWS OF THE FUNDUS GRASPER INSTRUMENT ALLEGEDLY BROKE AND FELL APART INSIDE THE PATIENT'S ABDOMEN. IT WAS INITIALLY REPORTED THAT THE SURGEON REMOVED THREE OF FOUR INSTRUMENT FRAGMENTS THAT FELL INSIDE THE PATIENT. THE FOURTH INSTRUMENT FRAGMENT ALLEGEDLY FELL BEHIND THE FIELD OF VISION AND COULD NOT BE RETRIEVED. THE SURGICAL PROCEDURE WAS REPORTEDLY COMPLETED WITH A REPLACEMENT FUNDUS GRASPER INSTRUMENT. ON (B)(6) 2017, INTUITIVE SURGICAL, INC. (ISI) CONTACTED THE SITE'S ROBOTICS COORDINATOR AND OBTAINED THE FOLLOWING INFORMATION REGARDING THE REPORTED EVENT: THE ROBOTICS COORDINATOR WAS PRESENT DURING THE SURGICAL PROCEDURE WHICH WAS NOT RECORDED ON VIDEO. WHEN THE EVENT OCCURRED, THE SURGEON HAD JUST LET GO OF THE GALLBLADDER WHICH WAS BEING HELD BY THE FUNDUS GRASPER INSTRUMENT. WHEN THE SURGEON ATTEMPTED TO RE-GRAB THE GALLBLADDER WITH THE FUNDUS GRASPER INSTRUMENT, THE INSTRUMENT ALLEGEDLY JUST FELL APART. AFTER THE INSTRUMENT BROKE, THE SURGICAL STAFF REMOVED THE INSTRUMENT AND RETRIEVED VISIBLE FRAGMENTS THAT HAD FALLEN INSIDE THE PATIENT. WHEN THE SURGICAL STAFF ATTEMPTED TO PUT ALL

  Patient problems: Foreign Body In Patient

  MAUDE report 6662309 ↗