EndoWrist 470190Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00886874112335), received between Nov 6, 2017 and Mar 6, 2026 — classified as 1 injury, 6 malfunctions.

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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 6, 2026Material Split, Cut or Torn

  REFER TO H11 FOR FOLLOW-UP INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24528291 ↗
• MalfunctionAug 11, 2025Detachment of Device or Device Component; No Apparent Adverse Event; Detachment of Device or Device Component; No Apparent Adverse Event

  IT WAS REPORTED THAT THE CUSTOMER EXPERIENCED AN ISSUE WITH AN INTUITIVE PRODUCT. THE CUSTOMER REPORTED EVENT HAS NO REPORT OF PATIENT INJURY. ISI FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: CUSTOMER ALLEGED THAT A CABLE WAS BROKEN AND ONE SIDE OF THE INSTRUMENT WAS LOOSE. THERE WAS NO FRAGMENT FALLING TO THE PATIENT BUT CUSOMER SAYS THAT THERE WAS A MISSING PART.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22778430 ↗
• MalfunctionMay 6, 2023Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT PRIOR TO THE START OF A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE COBRA GRASPER JAW WAS BROKEN. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16883603 ↗
• InjuryJun 30, 2022Defective Device; Defective Device

  IT WAS REPORTED DURING A DA VINCI-ASSISTED BENIGN HYSTERECTOMY THE COBRA GRASPER INSTRUMENT FRAYED DURING THE CASE INSIDE THE BODY. THERE WERE PIECES OF FIBER REMOVED. THE STAFF REMOVED THE INSTRUMENT AND REPLACED WITH A SPARE INSTRUMENT. INTUITIVE SURGICAL, INC. (ISI) RECEIVED MW5098024 ON (B)(6) 2020, STATING THE FOLLOWING: "COBRA INSTRUMENT FRAYED DURING THE CASE INSIDE THE BODY, PIECES OF FIBER WERE REMOVED. INSTRUMENT TAKEN OUT AND REPLACED." ISI HAS MADE SEVERAL ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION FROM THE REPORTER HOWEVER, NO FURTHER DETAILS HAVE BEEN RECEIVED AS OF THE DATE OF THIS REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14873797 ↗
• MalfunctionNov 21, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED MYOMECTOMY SURGICAL PROCEDURE, THE COBRA GRASPER BROKE WHILE BEING USED FOR EXTRACTING TISSUE. THERE WAS NO REPORT OF FRAGMENTS FALLING INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITH A BACKUP DA VINCI INSTRUMENT OF THE SAME KIND, AND THERE WAS NO REPORTED PATIENT INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER TO OBTAIN THE INFORMATION REGARDING PATIENT DEMOGRAPHICS, RELEVANT TESTING, AND MEDICAL HISTORY; HOWEVER, THE REPORTER WAS NOT ABLE TO PROVIDE THAT INFORMATION. NO FURTHER DETAILS WERE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12850101 ↗
• MalfunctionJan 22, 2021Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING CENTRAL PROCESSING, A BROKEN CABLE WAS NOTED. THERE WAS NO REPORT OF PATIENT INVOLVEMENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 11214441 ↗
• MalfunctionNov 6, 2017Break; Break

  IT WAS REPORTED THAT PRIOR TO THE START OF A DA VINCI-ASSISTED SURGICAL PROCEDURE, FRAYED WIRES WERE SHOWING ON THE COBRA GRASPER INSTRUMENT. THERE WAS NO REPORT OF PATIENT INVOLVEMENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7003694 ↗