NA 351.719Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10886982193957), received between Oct 3, 2024 and Oct 14, 2024 — classified as 1 injury, 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 14, 2024Break; Break

  ADDITIONAL INFORMATION RECEIVED STATES THAT THIS WAS A POST-OPERATIVE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20440254 ↗
• InjuryOct 7, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED 2/3 OF THE BASIC INSTRUMENTS OF THE TN ADVANCED WERE NOT SENT. THE EVENT WAS REPORTED BY THE TA WHEN THE PATIENT WAS ALREADY UNDER ANESTHESIA. IT SHOULD HAVE BEEN TAKEN OUT OF THE WAREHOUSE AS CODE BLUE TO BE DELIVERED.

  Patient problems: Insufficient Information

  MAUDE report 20385601 ↗
• MalfunctionOct 3, 2024Break; Contamination /Decontamination Problem; Break; Contamination /Decontamination Problem

  IT WAS REPORTED THAT ON (B)(6) 2024, THERE WAS A METAL SHARD ON THE SHAFT. NO OPERATION AND NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20359543 ↗