EndoWrist 470400Recalls & reported problems

Summary

The FDA's MAUDE database contains 111 adverse event reports that list this exact device (DI 00886874113530), received between Apr 11, 2017 and Jan 6, 2026 — classified as 30 injuries, 81 malfunctions.

The most frequently reported specific device problem is “Break” (40 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 25 most recent of 111 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 6, 2026Energy Output Problem

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE LONG BIPOLAR GRASPER INSTRUMENT HAD LOW ENERGY IN THE JAWS. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23984374 ↗
• MalfunctionAug 7, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  REFER TO H11 FOR FOLLOW-UP INFORMATION.

  Patient problems: Insufficient Information

  MAUDE report 22744341 ↗
• MalfunctionAug 5, 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 22722275 ↗
• MalfunctionJun 18, 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 22287887 ↗
• MalfunctionMay 30, 2025Material Split, Cut or Torn; Material 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 22119207 ↗
• MalfunctionMay 6, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE 8MM LONG BIPOLAR GRASPER INSTRUMENT HAD A BROKEN BLACK CONDUCTOR WIRE. A BACKUP INSTRUMENT WAS USED FOR THE PROCEDURE. THE PROCEDURE WAS COMPLETING AS PLANNED WITH NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21972893 ↗
• MalfunctionMay 6, 2025Material Split, Cut or Torn; Material 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 21972288 ↗
• MalfunctionMar 28, 2025Unintended System Motion; Unintended System Motion

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE CUSTOMER STATED THE LONG BIPOLAR GRASPER INSTRUMENT WAS NOT MOVING WELL AND IT WAS MALFUNCTIONING. THE PROCEDURE WAS COMPLETED AS PLANNED WITH NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21720783 ↗
• InjuryMar 18, 2025Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE LONG BIPOLAR GRASPER INSTRUMENT WAS PARTIALLY DAMAGED. A FRAGMENT FELL INSIDE THE PATIENT AND WAS RETRIEVED DURING THE SAME PROCEDURE WHICH WAS COMPLETED ROBOTICALLY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE LONG BIPOLAR GRASPER INSTRUMENT WAS INSPECTED PRIOR TO USE AND NO DAMAGE WAS NOTED. THE INSTRUMENT WAS IN USE FOR SEVERAL HOURS BEFORE THE BREAKAGE OCCURRED. THE SURGEON DID NOT NOTICE ANY ISSUES WITH THE FUNCTIONALITY OF THE INSTRUMENT. IT IS UNKNOWN IF THE INSTRUMENT COLLIDED WITH ANY OTHER INSTRUMENTS OR OTHER HARD MATERIAL DURING THE SURGICAL PROCEDURE. THE SURGICAL STAFF DID NOT NOTICE ANY DAMAGE TO THE CANNULA AFTER THE EVENT OCCURRED. THE FRAGMENT(S) WERE COLLECTED IN A BAG INSIDE THE PATIENT'S BODY. THE CUSTOMER CONFIRMED THAT ALL THE PIECES WERE RECOVERED. NO ADDITIONAL SURGICAL PROCEDURES WERE REQUIRED TO REMOVE THE FRAGMENTS. THERE WERE NO POSTOPERATIVE TESTS LIKE AN X-RAY OR ULTRASOUND WERE PERFORMED TO CHECK FOR REMAINING FRAGMENTS. THE PROCEDURE WAS COMPLETED ROBOTICALLY WITH NO INJURY TO THE PATIENT. THE PATIEN

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21637942 ↗
• MalfunctionNov 26, 2024Break; Break

  IT WAS REPORTED THAT PRIOR TO THE START OF A DA VINCI-ASSISTED SURGICAL PROCEDURE THAT THE LONG BIPOLAR GRASPER WAS FOUND TO HAVE A DAMAGED CONDUCTOR WIRE. THE PROCEDURE WAS COMPLETED WITH A BACKUP INSTRUMENT, WITH NO REPORTS OF PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20780449 ↗
• MalfunctionOct 28, 2024Thermal Decomposition of Device; Thermal Decomposition of Device

  IT WAS REPORTED THAT AFTER A DA VINCI-ASSISTED PARTIAL NEPHRECTOMY SURGICAL PROCEDURE, THE BASE OF THE TIP OF THE LONG BIPOLAR GRASPER INSTRUMENT WAS MELTED. NO FRAGMENT FELL INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETING AS PLANNED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: NO ARCING WAS OBSERVED DURING THE PROCEDURE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20541802 ↗
• InjuryOct 1, 2024Break; Break

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED PULMONARY LOBECTOMY SURGICAL PROCEDURE, A FRAGMENT FELL OFF THE LONG BIPOLAR GRASPER INSTRUMENT AND INTO THE PATIENT. THE FRAGMENT WAS RETRIEVED DURING THE SAME PROCEDURE. THE PROCEDURE WAS COMPLETED ROBOTICALLY.

  Patient problems: Foreign Body In Patient

  MAUDE report 20341175 ↗
• MalfunctionJul 17, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED PULMONARY LOBECTOMY SURGICAL PROCEDURE, THE LONG BIPOLAR GRASPER INSTRUMENT HAD A BROKEN CONDUCTOR WIRE. THE INSTRUMENT WAS REMOVED AND REPLACED WITH A BACKUP. FOLLOWING THIS, THE USER CONTINUED WITH THE PROCEDURE WITHOUT FURTHER ISSUES. NO FRAGMENT FELL INSIDE THE PATIENT. NO KNOWN IMPACT OR PATIENT CONSEQUENCE WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19766668 ↗
• MalfunctionJun 5, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING CENTRAL PROCESSING, THE DISTAL TIP OF THE LONG BIPOLAR GRASPER INSTRUMENT WAS LOOSE. THE BLACK WIRE WAS OUT OF PLACE. THERE WAS NO REPORT OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19469139 ↗
• MalfunctionApr 19, 2024Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT DURING AN DA VINCI-ASSISTED SURGICAL PROCEDURE, THE PLASTIC PART BROKE OFF AT THE TOP OF THE LONG BIPOLAR GRASPER INSTRUMENT. THE PROCEDURE WAS COMPLETED. NO KNOWN PATIENT CONSEQUENCE WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19149101 ↗
• MalfunctionNov 16, 2023Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED HYSTERECTOMY SURGICAL PROCEDURE, THE SURGEON WAS UNABLE TO USE THE INSTRUMENT DUE TO BIPOLAR CORD BEING DETACHED. THE AREA WAS INSPECTED, AND SURGEON DIDN'T SEE ANYTHING IN THE ABDOMEN. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER ON AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE OUTER AREA OF AN INSTRUMENT WAS INSPECTED; HOWEVER, IT WAS NOT NOTICED UNTIL THE JAWS WERE OPENED. THE ISSUE WAS NOTICED INTRAOPERATIVELY. ONCE THE JAWS WERE OPENED IT WAS NOTICED THAT CORD WAS BROKEN. THE INSTRUMENT DID NOT COLLIDE WITH ANOTHER INSTRUMENT. THERE WERE NO PROBLEMS REMOVING THROUGH THE CANNULA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18156262 ↗
• MalfunctionOct 18, 2023Thermal Decomposition of Device; Arcing; Detachment of Device or Device Component; Thermal Decomposition of Device; Arcing; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE LONG BIPOLAR GRASPER INSTRUMENT'S BLACK CORD WAS DAMAGED. THE INSTRUMENT WAS NOT USED. IT WAS REPLACED AND SURGERY WAS COMPLETED. NO FRAGMENTS FELL INTO THE PATIENT. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. 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 17962385 ↗
• MalfunctionSep 9, 2023Difficult to Open or Close; Difficult to Open or Close

  IT WAS REPORTED THAT PRIOR TO THE START OF A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE LONG BIPOLAR GRASPER JAWS WERE NOT CLOSING. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17716875 ↗
• InjuryJun 23, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED PULMONARY LOBECTOMY SURGICAL PROCEDURE, AN INSULATION PIECE CAME OFF THE LONG BIPOLAR GRASPER INSTRUMENT. THE PIECE DID FELL OFF INTO THE PATIENT AND WAS RETRIEVED. THE ISSUE WAS IDENTIFIED INTRAOPERATIVELY. A BACKUP INSTRUMENT WAS USED. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: IT IS UNKNOWN IF THE LONG BIPOLAR GRASPER INSTRUMENT WAS INSPECTED PRIOR TO USE. THE SURGICAL TASK BEING PERFORMED WAS DISSECTION. THE INSTRUMENT WAS IN USE FOR 30 MINUTES. THE PROCEDURE WAS SUBSEQUENTLY CONVERTED TO OPEN SURGERY UNRELATED TO INSTRUMENT ISSUE. THE SURGEON DID NOT NOTICE ANY ISSUES WITH THE FUNCTIONALITY OF THE INSTRUMENT DURING THE SURGICAL PROCEDURE. THE INSTRUMENT WAS NOT OBSERVED TO COLLIDE WITH ANY OTHER INSTRUMENTS OR OTHER HARD MATERIAL DURING THE SURGICAL PROCEDURE. THE FRAGMENT(S) DID NOT FALL INSIDE THE PATIENT DURING AN INSTRUMENT TIP / ACCESSORY COLLISION. THE SURGICAL STAFF DID NOT FEEL ANY RESISTANCE UPON REMOVAL OF THE INSTRUMENT THROUGH THE CANNULA. THE SURGICAL STAFF DID NOT NOTICE ANY DAMAGE TO THE CANNULA AFTER THE EVENT OCCURRED. THE SURGICAL STAFF

  Patient problems: Foreign Body In Patient

  MAUDE report 17190058 ↗
• MalfunctionMay 28, 2023Break; Material Fragmentation; Break; Material Fragmentation

  IT WAS REPORTED DURING A DA VINCI-ASSISTED PROCEDURE THE LONG BIPOLAR GRASPER INSTRUMENT WAS NOT WORKING WHEN THE SURGICAL STAFF TRIED TO USE BIPOLAR ENERGY. WHEN THE INSTRUMENT WAS PULLED OUT A SCRUB TECHNICIAN FOUND THE WIRE ON THE INSTRUMENT SNAPPED. THE SITE COMPLETED THE PROCEDURE AS PLANNED WITH NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17016037 ↗
• MalfunctionMay 28, 2023Break; Material Fragmentation; Break; Material Fragmentation

  IT WAS REPORTED, THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE. THE INSTRUMENT HAD A BROKEN CABLE. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17016033 ↗
• MalfunctionMay 28, 2023Break; Material Fragmentation; Break; Material Fragmentation

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED PULMONARY LOBECTOMY SURGICAL PROCEDURE, THE LONG BIPOLAR GRASPER INSTRUMENT HAD BROKEN WIRE AND THE WRIST COULD NOT BE STRAIGHTEN. THE INSTRUMENT WAS STUCK IN THE TROCAR AND THE TIP OF THE INSTRUMENT WAS NOTED TO BE DAMAGED. NO FRAGMENT FELL INTO THE PATIENT. THE PROCEDURE WAS COMPLETED. ISI FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED ADDITIONAL INFORMATION: THE OR STAFF WAS ABLE TO REMOVE THE INSTRUMENT ALONG WITH THE TROCAR FROM THE PATIENT WITHOUT ANY ISSUES. THE PROCEDURE WAS COMPLETED WITH NO INJURY TO THE PATIENT. REVIEW OF MW5093374 RECEIVED ON 03/23/2020 WAS REVIEWED AND DOES NOT IMPACT THE INITIAL REPORTABILITY DECISION OF NON-REPORTABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17016029 ↗
• MalfunctionMay 28, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE LONG BIPOLAR GRASPER DID NOT WORK AND HAD WIRES EXPOSED. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17016026 ↗
• MalfunctionMay 27, 2023Thermal Decomposition of Device; Thermal Decomposition of Device

  IT WAS REPORTED THAT DURING CENTRAL PROCESSING, IT WAS OBSERVED THAT THE LONG BIPOLAR GRASPER INSTRUMENT INSULATION PULLEY COVER WAS MELTED. THERE WAS NO REPORT OF PATIENT INVOLVEMENT. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: ARCING OCCURRED DURING THE LAST KNOWN INSTRUMENT USAGE BUT NO DAMAGE TO THE INSTRUMENT WAS NOTED AFTER THE ARCING EVENT. NO PATIENT INJURY OCCURRED DURING THE LAST TIME THE INSTRUMENT WAS USED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17015767 ↗
• MalfunctionMay 27, 2023Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING CENTRAL PROCESSING, PART OF THE CORD AT THE TIP OF THE LONG BIPOLAR FORCEPS WAS EXPOSED OR WAS COMING APART. THE BLACK COATING ON THE CABLE WAS COMING OFF. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17015765 ↗