None 430020Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00886874114353), received between Feb 1, 2024 and Dec 11, 2025 — classified as 1 injury, 3 malfunctions.

The most frequently reported specific device problem is “Material Fragmentation” (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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 11, 2025Material Fragmentation; Material Fragmentation

  THE SHEATH ACCESSORY WAS RETURNED TO ISI FOR EVALUATION WITH NO REPORTED ISSUE. AN INVESTIGATION HAS BEEN COMPLETED. THE SHEATH WAS RETURNED STILL INSTALLED ON THE ENDOSCOPE. VISUAL INSPECTION OF THE SHEATH FOUND IT TO BE DAMAGED. MULTIPLE TEARS MEASURING APPROXIMATELY 0.77 MM X 4.91 MM WERE FOUND ALONG THE LENGTH OF THE SHEATH. THERE WAS NO MATERIAL MISSING AS A RESULT. THE ROOT CAUSE OF THIS FAILURE IS ATTRIBUTED TO USER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23784269 ↗
• MalfunctionMay 21, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT PRIOR TO THE START OF A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE CUSTOMER FOUND THAT SINGLE-PORT (SP) CAMERA SHEATH HAD A HOLE. UPON REMOVING THE SHEATH, THE CONNECTION PART CRUMBLED AND DETACHED. THE CUSTOMER USED A BACKUP SHEATH TO CONTINUE WITH THE PLANNED PROCEDURE. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE NURSE AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: PORTS WERE NOT PLACED WHEN THE ISSUE WAS IDENTIFIED. THERE WAS NO FRAGMENT FALLING INSIDE THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22058282 ↗
• InjuryApr 28, 2025Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED THE RIGHT PARTIAL NEPHRECTOMY SURGICAL PROCEDURE, THE CAMERA SHEATH SHREDDED, AND A PIECE WAS HANGING. THE CUSTOMER WAS UNABLE TO ACCESS THE SHEATH INITIALLY DUE TO THE CLAP TIME. THE CUSTOMER PERFORMED AN X-RAY, AND IT WAS CONFIRMED THAT THERE WERE NO FRAGMENTS IN THE PATIENT. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21917415 ↗
• MalfunctionFeb 1, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  THE CAMERA SHEATH ACCESSORY WAS AN INCIDENTAL RETURN INCLUDED WITH RMA 1505840 WHICH ALLEGES THAT THE FIREFLY CAMERA WAS OUT OF LIVES. NO ALLEGATION WAS MADE AGAINST THIS PRODUCT. INTUITIVE SURGICAL INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND THE FOLLOWING ADDITIONAL INFORMATION WAS OBTAINED: THERE WERE NO REPORTS OF FRAGMENTS FALLING INTO THE PATIENT WHEN THE CAMERA SHEATH WAS LAST USED.

  Patient problems: Insufficient Information

  MAUDE report 18620454 ↗