EndoWrist 470381Recalls & reported problems

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 00886874112588), received between Mar 22, 2021 and Sep 29, 2026 — classified as 12 injuries, 8 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (12 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 23, 2021Open, Classified

   Conductive Cannula Reducer metal tip may get dislodged from the plastic shaft. If unnoticed, additional surgery may be required to remove the metal tip. If the procedure proceeds without the metal tip, there is potential for energy leakage, which could cause tissue damage. If the metal tip remains in the patient, adhesions may form, which may lead to bowel obstruction and chronic abdominal pain.

   Z-0702-2022 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 20 most recent of 20 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 29, 2026No Apparent Adverse Event

  Patient problems: Insufficient Information

  MAUDE report 50939649 ↗
• InjuryMar 24, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE TIP OF THE REDUCER ACCESSORY BROKE OFF AND FELL INSIDE THE PATIENT'S ABDOMINAL CAVITY. THE FRAGMENT WAS RETRIEVED DURING THE SAME SURGICAL PROCEDURE WHICH WAS COMPLETED ROBOTICALLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24675255 ↗
• MalfunctionNov 25, 2025Break; Break

  REFER TO H11 FOR FOLLOW-UP INFORMATION.

  Patient problems: Insufficient Information

  MAUDE report 23641350 ↗
• MalfunctionJul 1, 2025Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE VALVE WAS DAMAGED (CHIPPED) ON A REDUCER. THE PROCEDURE WAS COMPLETING AS PLANNED WITH NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22379103 ↗
• MalfunctionJun 10, 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 22177862 ↗
• MalfunctionDec 3, 2024Material Fragmentation; Material Fragmentation

  THE REDUCER WAS AN INCIDENTAL RETURN INCLUDED WITH RMA 302126000010. THERE WAS NO REPORTED ISSUE AGAINST THE REDUCER OR REPORTED PATIENT INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER, BUT NO ADDITIONAL INFORMATION WAS OBTAINED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20829048 ↗
• InjuryNov 4, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE METAL TIP WAS BROKEN AND FELL OFF FROM 12-8MM REDUCER. THE METAL END WAS FOUND IN ABDOMINAL CAVITY INCIDENTALLY. THE PROCEDURE WAS COMPLETING AS PLANNED WITH NO REPORTED INJURY.

  Patient problems: Foreign Body In Patient

  MAUDE report 20603992 ↗
• InjuryAug 27, 2024Break; Break

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED PANCREATODUODENECTOMY SURGICAL PROCEDURE, THE REDUCER GOT DAMAGED AND THE METAL RING FELL INTO THE PATIENT'S ABDOMEN. THE PROCEDURE WAS COMPLETED. INTUITIVE SURGICAL, INC. (ISI) OBTAINED THE FOLLOWING INFORMATION BASED ON FOLLOW-UP: WHEN THE INSTRUMENT WAS REMOVED, A FRAGMENT FELL INSIDE THE PATIENT. THE INSTRUMENT WAS IN USE FOR 2.5 HOURS. ALL FRAGMENTS WERE RETRIEVED AND CONFIRMED BY A DIAGNOSTIC LAPAROSCOPY. A LAPAROSCOPIC INSTRUMENT WAS USED TO REMOVE THE FRAGMENT. NO POST-OPERATIVE TESTS WERE CONDUCTED. THE PATIENT HAS NOT RETURNED TO THE HOSPITAL DUE TO POST-SURGICAL COMPLICATIONS. THE INSTRUMENT WAS INSPECTED PRIOR TO USE WITH NO DAMAGE OBSERVED. THE SURGEON DID NOT NOTICE ISSUES WITH THE FUNCTIONALITY OF THE INSTRUMENT. THE INSTRUMENT DID NOT COLLIDE WITH ANY INSTRUMENTS OR HARD MATERIAL. THE SURGICAL STAFF FELT NO RESISTANCE UPON REMOVING THE INSTRUMENT. UPON FINAL REMOVAL OF THE INSTRUMENT, THE WRIST WAS STRAIGHTENED, THE STAFF NOTICED NO DAMAGE TO THE CANNULA, AND THERE WAS NO FURTHER DAMAGE TO THE INSTRUMENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 20074680 ↗
• MalfunctionApr 9, 2024Crack; Crack

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED PULMONARY LOBECTOMY SURGICAL PROCEDURE, THE COLLAR OF THE REDUCER WAS CRACKED. THE CUSTOMER USED A BACKUP REDUCER TO CONTINUE WITH THE PLANNED PROCEDURE. NO FRAGMENT FELL INSIDE THE PATIENT. NO KNOWN IMPACT OR PATIENT CONSEQUENCE WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19068912 ↗
• InjuryApr 3, 2024Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE REDUCER HAD A METAL PART AND PLASTIC PIECES FALL OFF WHEN REMOVING THE CANNULA FROM THE PATIENT. ALL PIECES OF THE REDUCER WERE RETRIEVED DURING THE SAME PROCEDURE. THE PROCEDURE WAS COMPLETED USING A BACKUP REDUCER.

  Patient problems: Foreign Body In Patient

  MAUDE report 19031690 ↗
• InjuryMay 10, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE CUSTOMER STATED THAT THE REDUCER METAL RING FELL OFF DURING THE PROCEDURE. IT WAS ALSO NOTED THAT THE REDUCER HAD SNAPPED, AND PLASTIC FRAGMENTS FELL INTO THE PATIENT. THE FRAGMENTS WERE RETRIEVED WITHOUT AN ADDITIONAL PROCEDURE. 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: Foreign Body In Patient

  MAUDE report 16903787 ↗
• InjuryOct 12, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED LOW ANTERIOR RESECTION SURGICAL PROCEDURE, THE REDUCER VALVE FELL INSIDE THE PATIENT WHILE THE SURGEON WAS PERFORMING A COLON MOBILIZATION WITH A LAPAROSCOPIC INSTRUMENT THROUGH THE REDUCER. THE FRAGMENT WAS RETRIEVED WITH LAPAROSCOPIC INSTRUMENT FORCEPS DURING THE SAME PROCEDURE. THE CUSTOMER REPLACED THE REDUCER WITH A BACK-UP DEVICE OF THE SAME KIND AND COMPLETED THE PROCEDURE WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) HAS ATTEMPTED TO OBTAIN ADDITIONAL INFORMATION RELATED TO THE REPORTED EVENT. HOWEVER, AS OF THE DATE OF THIS REPORT, NO ADDITIONAL INFORMATION HAS BEEN PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15592663 ↗
• MalfunctionJan 6, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED VENTRAL HERNIA SURGICAL PROCEDURE, THE CUSTOMER USED THE REDUCER ON A 12MM TROCAR; HOWEVER, THE METAL PART AT THE TIP OF REDUCER WAS SEPARATED. ALTHOUGH THE METAL PART DID NOT FALL INSIDE THE PATIENT'S BODY, THE CUSTOMER WAS CONCERNED THAT IT COULD. A BACKUP REDUCER WAS USED TO CONTINUE THE PROCEDURE. THE PROCEDURE WAS COMPLETED WITH NO REPORT OF PATIENT INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE REDUCER WAS INSPECTED PRIOR TO USE WITH NO DAMAGE OBSERVED. THE CUSTOMER CONFIRMED THAT NOTHING FELL INSIDE OF THE PATIENT AND THAT THERE WAS NO PATIENT INJURY/HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13173794 ↗
• MalfunctionJan 6, 2022Defective Device; Defective Device

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE TOP PIECE OF THE CANNULA REDUCER WAS SEPARATED WHEN THE PACKAGE WAS OPENED. THE CANNULA REDUCER WAS NOT ABLE TO BE CONNECTED AND USED DUE TO THE SEPARATION. THE PROCEDURE WAS COMPLETED ROBOTICALLY WITH NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13173759 ↗
• InjuryDec 1, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12911116 ↗
• InjuryAug 8, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE TIP OF THE REDUCER CAME OFF AND FELL INSIDE THE PATIENT. THE PROCEDURE WAS REPORTEDLY COMPLETED. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE ISI CLINICAL SALES REP (CSR) AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION ON 13-JULY-2021. IT WAS CONFIRMED THAT THE FRAGMENT WAS RETRIEVED FROM THE PATIENT. THERE WAS NO PATIENT HARM AND NO POST-OP COMPLICATIONS. THE REPORTER WAS UNABLE TO CONFIRM IF THERE WERE ANY INSTRUMENT COLLISIONS OR INTERACTION WITH HARD SURFACES. THE CAUSE OF THE INSTRUMENT BREAKAGE WAS UNKNOWN. NO PATIENT DEMOGRAPHIC INFORMATION WAS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12292254 ↗
• InjuryMay 21, 2021Detachment 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 CUSTOMERS WERE NOT AWARE OF A PIECE BROKE OFF AND FELL INTO THE PATIENT UNTIL THEY FOUND IT. THE PIECE WAS RETRIEVED WITH A BACKUP 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 STATED THAT THE REDUCER CAME COMPLETELY OFF AND THERE WERE NO FRAGMENTS. THEY DID NOT REALIZE UNTIL THEY SAW IT LYING IN THE CHEST CAVITY. AS THE ISSUE WAS IDENTIFIED AT THE END OF THE CASE, THEY RETRIEVED THE REDUCER WITH THE FORCEPS. THERE WAS NO DAMAGE TO THE TROCAR UPON INSPECTION. IT WAS UNKNOWN WHY THE REDUCER CAME OFF. NO PHOTOGRAPHIC IMAGES OF THE DEVICE/FRAGMENT(S) OR A VIDEO RECORDING OF THE PROCEDURE WAS AVAILABLE FOR ISI REVIEW. INFORMATION REGARDING PATIENT DEMOGRAPHICS, RELEVANT TESTING, AND MEDICAL HISTORY WERE REQUESTED; HOWEVER, THE REPORTER WAS NOT ABLE TO PROVIDE THAT INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11861451 ↗
• InjuryMay 14, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11823943 ↗
• InjuryApr 26, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SLEEVE GASTRECTOMY SURGICAL PROCEDURE, THERE WAS A 12MM PORT SEAL PLACED AND A 12-8MM REDUCER PLACED IN THE PORT. THE INTUITIVE SURGICAL, INC. (ISI) CLINICAL SALES ASSOCIATE (CSA), WHO WAS PRESENT DURING THE PROCEDURE, INFORMED THE TECHNICAL SERVICE ENGINEER (TSE) THAT THE PORT WAS USED WITH THE 9MM INSTRUMENT FOR APPROXIMATELY AN HOUR. IT WAS NOTED THE 8MM INSTRUMENT WAS REMOVED AND THEN THE REDUCER WAS REMOVED. THE CUSTOMER INFORMED THEY DID NOT NOTICE ANY ISSUE WHEN THE REDUCER WAS REMOVED. A 12MM INSTRUMENT WAS PLACED INTO THE PORT AND IN DOING SO IT DISLODGED THE METAL TIP OF THE REDUCER FROM THE CANNULA AND IT FELL INTO THE PATIENT. THE SURGEON SCRUBBED BACK IN, WENT BEDSIDE TO SEARCH FOR THE METAL TIP, AND WAS ABLE TO REMOVE WITH A LAPAROSCOPIC GRASPER INSTRUMENT, WHILE ALSO REMOVING THE 12 MM PORT. THE CSA NOTED THAT THE ROBOTIC PORTION WAS COMPLETE AND THEY WERE JUST CLOSING THE PATIENT AT THE TIME OF THE CALL. THE CSA STATED THAT AT THE TIME OF THE INCIDENT, THE SURGEON WAS INSERTING THE STAPLER AND THE FRAGMENT FELL INTO THE PATIENT DURING AN INSTRUMENT TIP/ACCESSORY COLLISION. UPON THE INSTRUMENT REMOVAL, THE WRIST WAS STR

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11729427 ↗
• InjuryMar 22, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11543182 ↗