EndoWrist 471190Recalls & reported problems

Summary

The FDA's MAUDE database contains 23 adverse event reports that list this exact device (DI 00886874121481), received between Jun 17, 2022 and Mar 18, 2026 — classified as 2 injuries, 21 malfunctions.

The most frequently reported specific device problem is “Material Split, Cut or Torn” (5 reports).

1 FDA recall record name this device's identifier, 1 still open.

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.

Recalls naming this device

1. Dec 19, 2024Open, Classified

   Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.

   Z-0877-2025 · Root cause: Process change control · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 23 most recent of 23 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 18, 2026Material Frayed

  IT WAS REPORTED THAT THERE WAS A FRAYED CABLE WITH A DA VINCI PRODUCT. THE CUSTOMER REPORTED EVENT HAS NO REPORT OF PATIENT INJURY.

  Patient problems: Insufficient Information

  MAUDE report 24632086 ↗
• MalfunctionFeb 24, 2026Material Split, Cut or Torn

  IT WAS REPORTED THAT THERE WAS A BROKEN CABLE WITH A DA VINCI PRODUCT. THE CUSTOMER REPORTED EVENT HAS NO REPORT OF PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24437543 ↗
• MalfunctionJan 14, 2026Material Split, Cut or Torn

  REFER TO H11 FOR FOLLOW-UP INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24074873 ↗
• MalfunctionJan 14, 2026Break

  REFER TO H11 FOR FOLLOW-UP INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24074772 ↗
• MalfunctionJan 8, 2026Material Split, Cut or Torn

  REFER TO H11 FOR FOLLOW-UP INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24014887 ↗
• InjuryAug 15, 2025Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED BENIGN HYSTERECTOMY SURGICAL PROCEDURE, THE COBRA GRASPER INSTRUMENT "ATTACHED" TO THE BOWEL AND CAUSED A TISSUE INJURY OF THE PATIENT'S BOWEL WHEN ADVANCING INTO THE PATIENT CAVITY. THE CUSTOMER STATED THE INSTRUMENT WAS CLOSED DURING THE INITIAL INSTALL OF THE INSTRUMENT, AND NO ONE WAS PRESENT AT THE SURGEON SIDE CONSOLE (SSC). THE OPERATING ROOM (OR) STAFF WAS SUCCESSFULLY ABLE TO REMOVE THE COBRA GRASPER INSTRUMENT. THE SURGEON REPAIRED THE DAMAGED BOWEL LAPAROSCOPICALLY AND CONTINUED WITH THE PROCEDURE ROBOTICALLY.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 22815949 ↗
• MalfunctionJun 12, 2025Break; Break

  IT WAS REPORTED THAT DURING CENTRAL PROCESSING, THE 8MM COBRA GRASPER INSTRUMENT HAD A MISSING CLAMP. NO KNOWN IMPACT OR PATIENT CONSEQUENCE WAS REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 22198625 ↗
• MalfunctionMay 30, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  REFER TO H11 FOR FOLLOW-UP INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22118937 ↗
• MalfunctionMay 22, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT THE CUSTOMER EXPERIENCED AN ISSUE WITH AN INTUITIVE PRODUCT. THE CUSTOMER REPORTED EVENT HAS NO REPORT OF PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22074404 ↗
• MalfunctionMay 6, 2025Material Frayed; Material Frayed

  IT WAS REPORTED THAT DURING CENTRAL PROCESSING, THE 8MM COBRA GRASPER INSTRUMENT HAD A FRAYED CABLE. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT OR PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21972355 ↗
• InjuryMar 17, 2025Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED BENIGN HYSTERECTOMY PROCEDURE, THE TIP OF THE COBRA GRASPER INSTRUMENT BROKE. A FRAGMENT FELL INSIDE THE PATIENT AND WAS RETRIEVED DURING THE SAME PROCEDURE WHICH WAS COMPLETED ROBOTICALLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21620902 ↗
• MalfunctionMar 7, 2025Material Frayed; Material Frayed

  IT WAS REPORTED THAT THERE WAS A FRAYED CABLE WITH A DA VINCI PRODUCT. THE CUSTOMER REPORTED EVENT HAS NO REPORT OF PATIENT INJURY.

  Patient problems: Insufficient Information

  MAUDE report 21543848 ↗
• MalfunctionMar 6, 2025Break; Break

  REFER TO H11 FOR FOLLOW-UP INFORMATION.

  Patient problems: Insufficient Information

  MAUDE report 21533308 ↗
• MalfunctionJun 8, 2024Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT DURING CENTRAL PROCESSING, THERE WAS A BROKEN TIP ON THE COBRA GRASPER INSTRUMENT. THERE WAS NO REPORT OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19493727 ↗
• MalfunctionJan 6, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, HALF OF THE COBRA GRASPER INSTRUMENT JAW WAS MISSING. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18461091 ↗
• MalfunctionOct 24, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING CENTRAL PROCESSING, THE COBRA GRASPER INSTRUMENT HAD PHYSICAL DAMAGE TO THE METAL CONNECTOR AT THE TIP. NO KNOWN IMPACT OR PATIENT CONSEQUENCE WAS REPORTED. EVALUATION FOUND THE INSTRUMENT HAD THE MAIN TUBE BROKEN. 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: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18000160 ↗
• MalfunctionOct 12, 2023Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, A BROKEN JAW WAS NOTED CROKEN GRASPER. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY TO THE PATIENT. EVALUATION OF THE RETURNED DEVICE FOUND A PIECE OF THE GRIP BASE BROKEN OFF. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE CUSTOMER REPORTED THAT EVERYTHING WAS FILLED OUT ON THE COMPLAINT FORM AND THERE WAS NO FURTHER INFORMATION TO GIVE. THERE WAS NO SIGNIFICANT DAMAGE OR HARM.

  Patient problems: Insufficient Information

  MAUDE report 17923131 ↗
• MalfunctionJun 23, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING CENTRAL PROCESSING, A FRAGMENT FELL OFF OF THE COBRA GRASPER INSTRUMENT. THE PREVIOUS PROCEDURE HAD BEEN COMPLETED WITH NO REPORTED INJURY.

  Patient problems: Insufficient Information

  MAUDE report 17195416 ↗
• MalfunctionJan 5, 2023Difficult to Open or Close; Difficult to Open or Close

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED RADICAL EXTRAPERITONEAL WITHOUT LYMPHADENECTOMY PROSTATECTOMY SURGICAL PROCEDURE, THE COBRA GRASPER INSTRUMENT HAD INSUFFICIENT GRIP/GRIP FAILURE (JAWS NOT WORKING). A BACK-UP INSTRUMENT OF THE SAME KIND WAS USED, AND THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY OR DELAY. INTUITIVE SURGICAL, INC. (ISI) HAS REACHED OUT TO THE REPORTER TO OBTAIN ADDITIONAL PATIENT/EVENT INFORMATION BUT HAS NOT YET RECEIVED A RESPONSE AS OF THE DATE OF THIS REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16101158 ↗
• MalfunctionOct 29, 2022Difficult to Open or Close; Difficult to Open or Close

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED PROSTATECTOMY - SIMPLE SURGICAL PROCEDURE, THE COBRA GRASPER CLAMP WAS STUCK. 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 INSTRUMENT WAS USED TO GRASP A TISSUE THAT WAS CUT DURING THE SURGERY. WHEN THE TISSUE WAS BEING REMOVED (AFTER THE CUTTING STEP), THE SURGEON NOTICED THAT THE JAWS WERE STUCK IN IT. NO PIECE OF TISSUE WAS CUT TO RELEASE THE INSTRUMENT. THE SURGEON WAS ABLE TO REMOVE THE TISSUE BY PULLING IT GENTLY AND THEREFORE IT WAS NOT NECESSARY TO USE THE INSTRUMENT RELEASE SYSTEM. THE ISSUE DID NOT AFFECT THE PATIENT AND PROCEDURE OUTCOME. THE INSTRUMENT WAS INSPECTED PRIOR TO USE AND THERE WAS NO DAMAGE. THE PROCEDURE WAS COMPLETED WITH A BACKUP INSTRUMENT. NO PATIENT INFORMATION COULD BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15696390 ↗
• MalfunctionAug 14, 2022Break; Break

  IT WAS REPORTED THAT PRIOR TO THE START OF A DA VINCI-ASSISTED SIMPLE PROSTATECTOMY SURGICAL PROCEDURE, THE COBRA GRASPER WAS MISSING HALF OF THE JAW. 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 ISSUE WAS IDENTIFIED WHEN THE INSTRUMENT PACKAGING WAS OPENED. THE INSTRUMENT WAS NOT USED ON THE PATIENT. THE MISSING HALF OF THE JAWS WAS NOT LOCATED AND WILL NOT BE RETURNED WITH THE INSTRUMENT. A NEW INSTRUMENT WAS OPENED FOR USE IN THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15222718 ↗
• MalfunctionAug 9, 2022Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT PRIOR TO STARTING A DA VINCI-ASSISTED CHOLECYSTECTOMY SURGICAL PROCEDURE, THE COBRA GRASPER INSTRUMENT HAD HALF OF THE FORCEPS MISSING. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. THE COBRA GRASPER IS A MULTIPLE-USE ENDOSCOPIC INSTRUMENT WITH A GRASPING TIP TO BE USED IN CONJUNCTION WITH THE DA VINCI SYSTEM. THE INSTRUMENT IS DESIGNED TO GRAB, MANIPULATE, RETRACT, AND DISSECT TISSUE DURING A DA VINCI ASSISTED SURGICAL PROCEDURE. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE CUSTOMER CONFIRMED THAT THE PATIENT WAS NOT IN THE ROOM WHEN THE ISSUE WAS IDENTIFIED. THERE IS NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15195562 ↗
• MalfunctionJun 17, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING CENTRAL PROCESSING, THE COBRA GRASPER INSTRUMENT WAS MISSING THE OTHER TIP. THERE WAS NO REPORT OF PATIENT INVOLVEMENT. THE COBRA GRASPER IS A MULTIPLE-USE ENDOSCOPIC INSTRUMENT WITH A GRASPING TIP TO BE USED IN CONJUNCTION WITH THE DA VINCI SYSTEM. THE INSTRUMENT IS DESIGNED TO GRAB, MANIPULATE, RETRACT, AND DISSECT TISSUE DURING A DA VINCI ASSISTED SURGICAL PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14726583 ↗