None 470002Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00886874112137), received between Apr 18, 2024 and Dec 4, 2025 — classified as 4 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Break” (2 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 4, 2025No Apparent Adverse Event; No Apparent Adverse Event

  REFER TO H11 FOR FOLLOW-UP INFORMATION.

  Patient problems: Insufficient Information

  MAUDE report 23722026 ↗
• InjuryJul 10, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED MYOMECTOMY SURGICAL PROCEDURE, THE TIP WAS BENT, AND A PIECE OF THE BLACK PART FELL INSIDE THE PATIENT, BUT THE DOCTOR RETRIEVED IT. THE PROCEDURE WAS COMPLETED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22469190 ↗
• InjuryFeb 25, 2025Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED PARAESOPHAGEAL HIATAL HERNIA REPAIR PROCEDURE, THE COATING/METAL SHAVINGS ON SHAFT OF THE VESSEL SEALER EXTEND (VSE) INSTRUMENT SCRAPED OFF AND FELL INSIDE THE PATIENT'S ABDOMEN. THE INTUITIVE SURGICAL, INC. (ISI) CUSTOMER SALES REPRESENTATIVE (CSR) THAT WAS PRESENT DURING THE PROCEDURE STATED THAT THE SURGEON WAS ABLE TO REMOVE MOST OF THE METAL SHAVINGS. IT IS UNKNOWN IF ALL THE SHAVINGS WERE RETRIEVED. A POST OPERATIVE X-RAY WAS PERFORMED BUT THE RESULTS OF THE X-RAY ARE UNKNOWN. THE SURGEON REPORTED THAT THE PATIENT HAS NOT RETURNED WITH ANY POST-OPERATIVE COMPLICATIONS.

  Patient problems: Foreign Body In Patient

  MAUDE report 21461411 ↗
• InjuryAug 20, 2024Break; Break

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED ABDOMINOPERINEAL RESECTION (APR) SURGICAL PROCEDURE, THE FENESTRATED BIPOLAR FORCEPS INSTRUMENT BROKE AT THE TIP AND COULD NOT BE REMOVED BY THE TROCAR SO THE TROCAR, ALONG WITH THE INSTRUMENT HAD TO BE REMOVED FROM THE PATIENT. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY.

  Patient problems: Foreign Body In Patient

  MAUDE report 20003800 ↗
• MalfunctionJun 8, 2024Break; Break

  REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19494532 ↗
• InjuryApr 18, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS INITIALLY REPORTED THAT DURING DA VINCI ASSISTED SURGICAL PROCEDURE, A MEGA NEEDLE DRIVER INSTRUMENT BROKE INSIDE THE PATIENT AND RESULTED IN FRAGMENT(S) FALLING INSIDE THE PATIENT. IT WAS LATER REPORTED THAT THE SURGICAL STAFF NOTICED PIECES BROKEN OFF FROM THE CANNULA. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE INSTRUMENT WAS INSPECTED PRIOR TO USE WITH NO NOTED DAMAGE. SUTURING WAS BEING PERFORMED WHEN THE INSTRUMENT BROKE. THE REPORTED STATED THAT TWO PIECES BROKE OFF AND ALL FRAGMENTS WERE RETRIEVED FROM THE PATIENT. THE SURGEON DID NOT NOTICE ANY ISSUES WITH THE FUNCTIONALITY OF THE INSTRUMENT DURING THE SURGICAL PROCEDURE. THE INSTRUMENT REPORTEDLY DID NOT COLLIDE WITH ANY OTHER INSTRUMENTS OR OTHER HARD MATERIALS DURING THE SURGICAL PROCEDURE; HOWEVER, THE REPORTER INDICATED THAT THE FRAGMENT FELL INSIDE THE PATIENT DURING AN INSTRUMENT TIP/ACCESSORY COLLISION. UPON FINAL REMOVAL OF THE INSTRUMENT, THE WRIST WAS STRAIGHTENED, AND THE SURGICAL STAFF DID NOT FEEL ANY RESISTANCE OF THE INSTRUMENT THROUGH THE CANNULA. THE SURGICAL STAFF DID NOT NOTICE ANY OTHER DAMAGE TO THE INSTRUMENT AFTER

  Patient problems: Foreign Body In Patient

  MAUDE report 19130256 ↗