EndoWrist 470309Recalls & reported problems

Summary

The FDA's MAUDE database contains 26 adverse event reports that list this exact device (DI 00886874112434), received between May 1, 2017 and Mar 24, 2026 — classified as 3 injuries, 23 malfunctions.

The most frequently reported specific device problem is “Break” (13 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. How this data works · Data updated Oct 13, 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-0865-2025 · Root cause: Process change control · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 26 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 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. ISI FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: CAN YOU CONFIRM WITH THE CUSTOMER THAT, INDEED, ALL 3 INSTRUMENTS WERE USED DURING THE TRAINING? ''I RECEIVED CONFIRMATION FROM OUR REPRESENTATIVE, THOSE WERE TRAINING INSTRUMENTS AND USED FOR TRAINING.

  Patient problems: Insufficient Information

  MAUDE report 24678591 ↗
• MalfunctionMar 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: Insufficient Information

  MAUDE report 24671939 ↗
• MalfunctionJun 18, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING CENTRAL PROCESSING, THE 8MM MEGA SUTURECUT NEEDLE DRIVER INSTRUMENT HAD A BROKEN CABLE. THERE WERE NO REPORTS OF PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22288160 ↗
• MalfunctionMar 12, 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 21588573 ↗
• MalfunctionMay 13, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED, THAT THE MEGA SUTURECUT NEEDLE DRIVER INSTRUMENT WAS BROKEN/LOOSE. THERE WAS NO REPORT OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16926730 ↗
• MalfunctionMay 6, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT AFTER A DA VINCI-ASSISTED SURGICAL PROCEDURE, END OF A MEGA SUTURE CUT NEEDLE DRIVER INSTRUMENT HAD SLIPPED OFF AND WAS LODGED ON THE SIDE OF THE INSTRUMENT SHAFT. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. ON (B)(6) 2020, INTUITIVE SURGICAL, INC. (ISI) OBTAINED THE FOLLOWING ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT: AFTER A DA VINCI-ASSISTED SURGICAL PROCEDURE, IT WAS OBSERVED THAT THE TIP/END OF A MEGA SUTURE CUT NEEDLE DRIVER INSTRUMENT HAD SLIPPED AND HAD BECOME LODGED ON THE SIDE OF THE SHAFT. THERE WAS NO REPORT OF FRAGMENT FALL INTO THE PATIENT OR ANY OTHER ADDITIONAL PIECE SLIPPING. IT WAS UNKNOWN IF THE INSTRUMENT WAS EVEN USED DURING THIS PROCEDURE. THE PROCEDURE COMPLETED ROBOTICALLY WITH NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16883427 ↗
• MalfunctionMay 6, 2023Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  IT WAS REPORTED PRIOR TO STARTING A DA VINCI-ASSISTED PROCEDURE, ONE OF THE ENDS BROKE OFF THE MEGA SUTURECUT NEEDLE DRIVER INSTRUMENT. THE PROCEDURE WAS COMPLETED WITH NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16883426 ↗
• MalfunctionMay 6, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING CENTRAL PROCESSING, A BROKEN TIP OF MEGA SUTURE CUT NEEDLE DRIVER WAS REPORTED. THERE WAS NO REPORT OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16883425 ↗
• MalfunctionMar 18, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING CENTRAL PROCESSING, A TIP HAD FALLEN OFF ON ONE SIDE OF THE MEGA SUTURECUT NEEDLE DRIVER. THERE WAS NO REPORT OF PATIENT INVOLVEMENT. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE CUSTOMER CONFIRMED THAT THE ISSUE WAS IDENTIFIED DURING THE CENTRAL PROCESSING. THE PROCEDURE PRIOR WAS COMPLETED AS PLANNED. THE CUSTOMER WAS NOT SURE IF THE INSTRUMENT WAS USED DURING THE CASE, OR IF ANOTHER WAS USED IN ITS PLACE. THE DETAILS OF THE PROCEDURE ARE UNKNOWN. TO THE CUSTOMER'S KNOWLEDGE, THERE WAS NO REPORT OF FRAGMENTS FALLING INTO THE PATIENT. THE INSTRUMENT CLEANING OR STERILIZATION PROCESS HAS NOT BEEN CHANGED. THERE WERE NO PHOTO IMAGES OR VIDEO RECORDINGS AVAILABLE FOR ISI REVIEW.

  Patient problems: Insufficient Information

  MAUDE report 16570102 ↗
• InjurySep 18, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED INCISIONAL HERNIA TAPP SURGICAL PROCEDURE, THE INTUITIVE SURGICAL, INC. (ISI) CLINICAL SALES REPRESENTATIVE (CSR) CALLED THE ISI TECHNICAL SERVICE ENGINEER (TSE) AND STATED THAT THE MEGA SUTURECUT NEEDLE DRIVER INSTRUMENT BROKE NEAR THE CUT PORTION OF THE JAW. PIECES FELL INTO THE PATIENT AND WERE RETRIEVED BY THE SURGEON. THE TSE RECOMMENDED RETURNING THE FAILED INSTRUMENT FOR FAILURE ANALYSIS. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE SURGEON AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE SURGEON STATED THAT, WHILE PASSING A NEEDLE FROM ONE HAND TO THE INSTRUMENT, THE INSTRUMENT COLLIDED WITH THE NEEDLE. AT THAT TIME, THE SURGEON NOTED A FRAGMENT FALLING INTO THE PATIENT. UNDER DIRECT VISUALIZATION, THE SURGEON USED A MARYLAND BIPOLAR FORCEPS INSTRUMENT TO RETRIEVE THE FRAGMENT LAPAROSCOPICALLY. NO POST-OPERATIVE TESTING WAS PERFORMED AS A RESULT OF THE REPORTED ISSUE. ADDITIONALLY, THE SURGEON INDICATED THAT THE INSTRUMENT HAD BEEN REMOVED DURING THE PROCEDURE (PRIOR TO THE BREAKAGE). THE WRIST OF THE INSTRUMENT WAS STRAIGHTENED PRIOR TO REMOVAL. NOTHING OUT OF

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15443585 ↗
• MalfunctionAug 20, 2022Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT DURING A DA VINCI- ASSISTED MALIGNANT HYSTERECTOMY SURGICAL PROCEDURE, THE TIP OF THE MEGA SUTURECUT NEEDLE DRIVER INSTRUMENT COULD NO LONGER BE OPENED AND CLOSED. IT WAS REPORTEDLY UNKNOWN IF A FRAGMENT FROM THE INSTRUMENT HAD FALLEN INSIDE THE PATIENT. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE INSTRUMENT WAS IN USE FOR ABOUT 30 MINUTES PRIOR TO THE ISSUE. THE PROCEDURE WAS COMPLETED ROBOTICALLY WITH NO REPORT OF PATIENT INJURY. NO OTHER INFORMATION WAS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15263474 ↗
• MalfunctionJun 7, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING CENTRAL PROCESSING, THE CUSTOMER OBSERVED WIRES PROTRUDING FROM THE 8MM MEGA SUTURECUT NEEDLE DRIVER. THERE WAS NO REPORT OF PATIENT INVOLVEMENT. INTUITIVE SURGICAL INC. (ISI) MADE MULTIPLE FOLLOW-UPS 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 11952828 ↗
• MalfunctionMar 7, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING CENTRAL PROCESSING, THE INSTRUMENT CABLE "POPPED". THERE WAS NO REPORT OF PATIENT INVOLVEMENT. INTUITIVE SURGICAL INC. (ISI) COMPLETED CUSTOMER FOLLOW-UP AND OBTAINED THE FOLLOWING INFORMATION: THE INSTRUMENT WAS INSPECTED PRIOR TO USE AND THERE WAS NO DAMAGE IDENTIFIED. THE CUSTOMER CONFIRMED THERE WERE NO FRAGMENTS THAT FELL INSIDE THE PATIENT DURING LAST USAGE. PATIENT INFORMATION WAS REQUESTED, BUT WAS UNAVAILABLE. ALSO, THE OPERATING ROOM STAFF CONFIRMED THAT THE INSTRUMENT WAS NEVER USED/INSERTED INTO THE SURGICAL FIELD. THE BROKEN INSTRUMENT WAS IDENTIFIED OUTSIDE OF THE PROCEDURE AND PROCESSED FOR RETURN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11427684 ↗
• MalfunctionJan 18, 2021Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING CENTRAL PROCESSING, THE MEGA SUTURECUT NEEDLE DRIVER HAD A LOOSE CABLE. THERE WAS NO PATIENT INVOLVEMENT. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE REPORTER STATED THAT IT WAS DIFFICULT TO PROVIDE ADDITIONAL INFORMATION AS THEY SENT SEVERAL RMA'S DURING THE DAY, FROM 2 DIFFERENT ROBOTS. NO FURTHER DETAILS WERE AVAILABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 11184072 ↗
• InjuryNov 14, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 10841051 ↗
• MalfunctionAug 26, 2020Break; Break

  IT WAS REPORTED THAT PRIOR TO A DA VINCI ASSISTED PROCEDURE, THE MEGA SUTURECUT NEEDLE HAD A BROKEN WIRE. THE PROCEDURE WAS COMPLETED AND THERE WAS NO PATIENT INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER IN AN ATTEMPT TO OBTAIN ADDITIONAL INFORMATION. HOWEVER, THE REPORTER STATED THAT SHE HAD PROVIDED AL THE INFORMATION WHILE RETURNING THE INSTRUMENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10452800 ↗
• MalfunctionAug 26, 2020Break; Break

  IT WAS REPORTED THAT DURING A DA VINCI ASSISTED PROCEDURE, THE WIRE ON THE TIP OF THE MEGA SUTURECUT NEEDLE DRIVER WAS BROKEN. THE PROCEDURE WAS COMPLETED AND THERE WAS NO PATIENT INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER IN AN ATTEMPT TO OBTAIN ADDITIONAL INFORMATION. THE REPORTER STATED THAT ALL THE INFORMATION WAS PROVIDED WHEN THE INSTRUMENT WAS RETURNED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10452510 ↗
• InjuryJul 15, 2020Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 10274589 ↗
• MalfunctionJun 9, 2020Break; Break

  REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10135586 ↗
• MalfunctionApr 1, 2020Break; Break

  IT WAS REPORTED THAT PRIOR TO THE START OF A DA VINCI-ASSISTED SURGICAL PROCEDURE, AN INSTRUMENT WAS FOUND TO HAVE A BROKEN CABLE. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) MADE FOLLOW-UP ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION. HOWEVER, NO FURTHER DETAILS HAVE BEEN RECEIVED AS OF THE DATE OF THIS REPORT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9913653 ↗
• MalfunctionJun 26, 2019Break; 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 8MM MEGA SUTURECUT NEEDLE DRIVER INSTRUMENT HAD A BROKEN CABLE. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8734721 ↗
• MalfunctionJul 31, 2018Break; Break

  IT WAS REPORTED THAT DURING A DA-VINCI ASSISTED SURGICAL PROCEDURE, THE MEGA SUTURECUT NEEDLE DRIVER HAD A BROKEN CABLE. THERE WAS NO REPORT OF FRAGMENTS FALLING INSIDE THE PATIENT. THE PLANNED SURGICAL PROCEDURE WAS COMPLETED AND NO PATIENT HARM, ADVERSE OUTCOME, OR INJURY WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7735778 ↗
• MalfunctionJan 31, 2018Break; Break

  THE MEGA SUTURCUT NEEDLE DRIVER INSTRUMENT WAS RETURNED TO INTUITIVE SURGICAL, INC. (ISI) WITHOUT A REPORTED FAILURE. ISI MADE MULTIPLE FOLLOW UP ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION, HOWEVER, NO INFORMATION HAS BEEN RECEIVED AS OF DATE OF THIS REPORT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7231380 ↗
• MalfunctionJun 29, 2017Break; Break

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, A BROKEN CABLE WAS OBSERVED ON THE MEGA SUTURECUT NEEDLE INSTRUMENT. THERE WAS NO REPORT OF FRAGMENT(S) FALLING INSIDE THE PATIENT, PATIENT HARM, ADVERSE OUTCOME OR INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6677378 ↗
• MalfunctionJun 22, 2017Break; Break

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE CUSTOMER OBSERVED A BROKEN CABLE AT THE TIP OF THE MEGA SUTURE CUT NEEDLE DRIVER INSTRUMENT. THERE WAS NO REPORT OF FRAGMENT(S) FALLING INSIDE THE PATIENT, PATIENT HARM, ADVERSE OUTCOME OR INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6662373 ↗