Single-Site 478059Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 00886874113639), received between Jun 1, 2018 and Sep 21, 2026 — classified as 6 injuries, 8 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (7 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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 21, 2026Entrapment of Device

  It was reported that during a da Vinci-assisted surgical procedure, the instrument did not move while tissue was trapped. The customer removed the instrument using the Instrument Release Kit (IRK). The procedure was completed with no reported injury.ISI followed up with the initial reporter and obtained the following additional information: The tissue adhered to the instrument was gallbladder tissue inside the jaws. No tissue was removed during the event. There was no bleeding due to this event. The patient did not experience any post operative complications.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50842877 ↗
• MalfunctionAug 5, 2025Break; Break

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL COMPLETION PROCTECTOMY PROCEDURE, THE CUSTOMER REPORTED THE CROCODILE GRASPER INSTRUMENT TIP BROKE. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22722328 ↗
• InjuryJul 8, 2025Material Fragmentation; Material Fragmentation

  REFER TO H11 FOR FOLLOW-UP INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22436708 ↗
• MalfunctionOct 6, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT PRIOR TO STARTING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE JAWS OF A SINGLE-SITE CROCODILE GRASPER INSTRUMENT WERE BROKEN. THE PROCEDURE WAS COMPLETED. INTUITIVE SURGICAL, INC. (ISI) CONTACTED THE INITIAL REPORTER, BUT NO ADDITIONAL INFORMATION ABOUT THE COMPLAINT COULD BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17886840 ↗
• MalfunctionMay 27, 2023Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE CROCKODILE GRASPER HAD A BROKEN CABLE. THE PROCEDURE WAS COMPLETING AS PLANNED WITH NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17015669 ↗
• InjuryMay 13, 2023Break; Break

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE JAW OF THE CROCODILE GRASPER BROKE AND FELL INSIDE THE PATIENT'S ABDOMEN. A BACKUP INSTRUMENT WAS USED TO CONTINUE. ALL FRAGMENTS WERE RETRIEVED AND NO ADDITIONAL SURGICAL INTERVENTION WAS REQUIRED. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE OPERATING ROOM (OR) NURSE AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE PATIENT IS KOREAN/ASIAN. THE CUSTOMER RETRIEVED THE FRAGMENTS USING A LAPAROSCOPE. ALL FRAGMENTS WERE RETRIEVED WITH NO ADDITIONAL SURGICAL PROCEDURE REQUIRED. THE CUSTOMER DID NOT PERFORM ANY POST-OPERATIVE TESTS TO CHECK FOR REMAINING FRAGMENTS. THE SURGEON CONTINUED USING THE INSTRUMENT IN THE SURGERY FROM MORNING TO AFTERNOON. THE INSTRUMENT WAS INSPECTED PRIOR TO USE. THE INSTRUMENT WAS GRASPING TISSUE WHEN THE ISSUE OCCURRED. DURING THE PROCEDURE, THE SURGEON FELT A LITTLE STIFF WHILE OPENING THE TIP. THE INSTRUMENT DID NOT COLLIDE WITH ANY OTHER INSTRUMENTS OR OTHER HARD MATERIAL DURING THE SURGICAL PROCEDURE. THE INSTRUMENT WAS NEVER REMOVED PRIOR TO THE BREAKAGE. UPON THE FINAL REMOVAL OF THE INSTRUMENT, THE WRIST WAS STRAIG

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16928147 ↗
• InjuryMay 13, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, A FRAGMENT FROM A CROCODILE GRASPER INSTRUMENT BROKE OFF INSIDE THE PATIENT WHEN THE SURGEON GRASPING WITH THE INSTRUMENT. THE FRAGMENT WAS RETRIEVED IN THE SAME PROCEDURE BY A THE BACKUP CROCODILE GRASPER INSTRUMENT, THE EVENT WAS NOT CAUSED BY AN INSTRUMENT COLLISION AND THE PROCEDURE WAS COMPLETED AS PLANNED. INTUITIVE SURGICAL, INC. MADE MULTIPLE UNSUCCESSFUL ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION.

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

  MAUDE report 16928120 ↗
• MalfunctionMay 6, 2023Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT AFTER A DA VINCI-ASSISTED PROCEDURE THE CUSTOMER HAD A DAMAGED SHEATH ON THE CROCODILE GRASPER. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16883605 ↗
• MalfunctionMay 6, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE CROCODILE GRASPER HAD BROKEN TIP WHILE USING. THERE WAS NO REPORTED FRAGMENT FALL INTO PATIENT. THE CUSTOMER USED A BACKUP INSTRUMENT TO CONTINUE. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16883602 ↗
• MalfunctionOct 6, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT PRIOR TO STARTING A DA VINCI-ASSISTED CHOLECYSTECTOMY SURGICAL PROCEDURE, THE SCREW OF THE CROCODILE GRASPER INSTRUMENT WAS SEPARATED. THE CUSTOMER DID NOT USE THE INSTRUMENT. 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 CUSTOMER INSPECTED THE INSTRUMENT PRIOR TO STARTING THE PROCEDURE AND NOTICED THE ISSUE. THE INSTRUMENT WAS NOT USED ON THE INSTRUMENT SO THERE WAS NO FRAGMENT FELL INTO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15556792 ↗
• InjuryMar 8, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED CHOLECYSTECTOMY SURGICAL PROCEDURE, AN UNKNOWN INSTRUMENT BROKE AND FRAGMENTS FELL INSIDE THE PATIENT. THE CUSTOMER PERFORMED AN X-RAY TO CONFIRM ALL FRAGMENTS WERE RETRIEVED. THE PROCEDURE WAS COMPLETED AS PLANNED WITH NO REPORTED PATIENT INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER (CLINICAL SALES REPRESENTATIVE) AND OBTAINED ADDITIONAL INFORMATION: THE AFFECTED INSTRUMENT WAS A CROCODILE GRASPER (PART NUMBER: 478059, LOT NUMBER: S10170623 0003). THE INSTRUMENT WAS INSPECTED PRIOR TO USE AND NO DAMAGE WAS NOTED. THE INSTRUMENT WAS USED FOR APPROXIMATELY TWO HOURS PRIOR TO THE REPORTED ISSUE. THE SURGEON WAS LIFTING THE LIVER TO RETRACT THE GALLBLADDER WHEN THE INSTRUMENT BROKE AND FRAGMENTS FELL INSIDE THE PATIENT. BROKEN PIECES WERE RETRIEVED USING A LAPAROSCOPIC GRASPER INSTRUMENT. ALL FRAGMENTS WERE RETRIEVED, AND THIS WAS CONFIRMED VIA VISION SIDE CART (VSC) AND X-RAY IMAGING. THE SURGEON DID NOT NOTICE ANY ISSUES WITH THE FUNCTIONALITY OF THE INSTRUMENT DURING THE SURGICAL PROCEDURE. THE INSTRUMENT DID NOT COLLIDE WITH ANY OTHER INSTRUMENTS OR OTHER HARD MATERIAL DURING THE SURGICAL PROCEDURE.

  Patient problems: Foreign Body In Patient

  MAUDE report 13692649 ↗
• InjuryJul 6, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED LIVER RESECTION SURGICAL PROCEDURE, THE CROCODILE GRASPER INSTRUMENT WAS FOUND TO HAVE A LOOSE AND BROKEN SCREW. THE SCREW REPORTEDLY FELL INSIDE THE PATIENT AND WAS NOT RETRIEVED. A SIMILAR BACKUP DA VINCI INSTRUMENT WAS USED. 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 INSTRUMENT WAS INSPECTED PRIOR TO USE WITH NO DAMAGE. THE INSTRUMENT WAS IN USE FOR APPROXIMATELY 30 MINUTES AND BROKE WHILE IT WAS BEING USED FOR RETRACTING TISSUE. ALL THE FRAGMENTS WERE ACTUALLY RETRIEVED DURING THE SAME PROCEDURE AND WAS CONFIRMED WITH VISUAL INSPECTION. IT WAS UNKNOWN WHAT CAUSED THE BREAKAGE TO OCCUR AS THE INSTRUMENT DID NOT COLLIDE WITH ANY HARD MATERIALS OR OTHER INSTRUMENTS. THE SURGEON DID NOT NOTICE ANY ISSUES WITH THE FUNCTIONALITY OF THE INSTRUMENT. THE FRAGMENT DID NOT FALL INSIDE THE PATIENT DURING AN INSTRUMENT TIP OR ACCESSORY COLLISION. THE INSTRUMENT WAS NOT REMOVED DURING THE PROCEDURE (PRIOR TO THE BREAKAGE). UPON FINAL REMOVAL OF THE INSTRUMENT, THE WRIST WAS STRA

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12119924 ↗
• InjuryFeb 21, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9742354 ↗
• MalfunctionJun 1, 2018Break; Break

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED CHOLECYSTECTOMY PROCEDURE, A PIECE FROM THE CROCODILE GRASPER INSTRUMENT BROKE INSIDE THE PATIENT¿S ABDOMEN. THE BROKEN INSTRUMENT JAW THAT FELL INSIDE THE PATIENT WAS RECOVERED EASILY WHILE THE OTHER PIECE REQUIRED AN X-RAY TO DETERMINE ITS LOCATION. THE MISSING PIECE WAS LOCATED AND REMOVED FROM THE PATIENT¿S ABDOMEN. UPON INSPECTION BY THE SURGEON, THE OR PERSONNEL AND THE INTUITIVE SURGICAL, INC. (ISI) CLINICAL SALES REPRESENTATIVE (CSR) ALL AGREED THAT ALL THE MISSING PIECES WERE RECOVERED AND NO OTHER INSTRUMENT FRAGMENT WAS LEFT INSIDE THE PATIENT. INTUITIVE SURGICAL, INC. (ISI) OBTAINED THE FOLLOWING ADDITIONAL INFORMATION FROM THE ISI CSR: THE CSR CONFIRMED THAT THE OR STAFF USED A MANUAL LAPAROSCOPIC GRASPER TO REMOVE THE BROKEN FRAGMENTS FROM THE PATIENT WITH NO ADDITIONAL MEDICAL INTERVENTION.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 7562563 ↗