None 470319Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00886874112458), received between Aug 9, 2025 and Aug 9, 2025 — classified as 1 malfunction.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (1 report).

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 9, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT AFTER A DA VINCI-ASSISTED OROPHARYNGECTOMY PROCEDURE, A BURN INJURY WAS OBSERVED ON THE PATIENT'S LIP. THE MONOPOLAR CURVED SCISSORS (MCS) INSTRUMENT HAD BEEN USED IN THE AREA WHERE THE INJURY OCCURRED. THE SURGEON SPECULATED THAT THE PATIENT'S LIPS MAY HAVE COME INTO CONTACT WITH THE FLARED CANNULA DURING THE PROCEDURE, AS NO OTHER INSTRUMENTS CONTACTED THE LIPS. THE BURN WAS CLASSIFIED AS FIRST-DEGREE, APPEARING RED WITHOUT BRUISING OR CHARRING. BURN OINTMENT WAS APPLIED, AND NO FURTHER INTERVENTION, SUCH AS TISSUE EXCISION, WAS NECESSARY. THE EXACT CAUSE OF THE INCIDENT REMAINS UNKNOWN, INCLUDING WHETHER ARCING OCCURRED DURING THE PROCEDURE. ALL INSTRUMENTS AND THE FLARED CANNULA WERE INSPECTED AND THERE WAS NO DAMAGE OR ABNORMALITIES OBSERVED. THE PATIENT DID NOT EXPERIENCE ANY OTHER POST-OPERATIVE COMPLICATIONS AND HAS SINCE BEEN DISCHARGED.

  Patient problems: Burn(s)

  MAUDE report 22766642 ↗