NA 1898001 (UDI 00643169588103)Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00643169588103), received between Jun 22, 2023 and Jun 22, 2023 — classified as 1 injury.

The most frequently reported specific device problem is “Electrical /Electronic Property Problem” (1 report).

1 other recall cover devices cleared under the same FDA submission (K081277); they may or may not involve this specific model.

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.

• InjuryJun 22, 2023Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  IT WAS REPORTED THAT DURING THE SINUS SURGERY, SOMETIME AFTER SURGERY THE POWER SYSTEM OF THE OPERATION SUDDENLY FAILED AND COULD NOT BE USED, RESULTING IN PROLONGED OPERATION TIME, POSTOPERATIVE INFECTION, AND PERMANENT PERFORATION OF THE NASAL SEPTUM. A FAULT CODE (UNKNOWN CODE) OCCURRED DURING THE USE OF THE DEVICE. AFTER THE EVENT, THE INSPECTION RESULTS OF THE MAINTENANCE DEPARTMENT SHOWED THAT THE MAIN BOARD WAS FAULTY. THE MACHINE WAS REPAIRED AND STARTED NORMAL USE. THE PATIENT WAS INFORMED OF THE PERFORATION OF THE NASAL SEPTUM AND THE PRECAUTIONS AFTER THE PERFORATION WERE EXPLAINED.

  Patient problems: Sinus Perforation; Unspecified Infection

  MAUDE report 17183166 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K081277. One submission often covers many models, so check the product and lot details in each record.

• Z-0961-2022 · Dec 15, 2021 · Terminated
  Software 1898072 IPC upgrade v 2.7.3.0, IPC System: a) CONSOLE 1898001 IPC, Product Number 1898001; b) CONSOLE IPC REFURB, Product Number EC300RF; c) MASTER CONSOLE EC300 LEGEND E