NA EC300 (UDI 00643169588141)Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00643169588141), received between Dec 28, 2023 and Dec 28, 2023 — classified as 1 injury.

The most frequently reported specific device problem is “Power 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.

• InjuryDec 28, 2023Power Problem; Power Problem

  IT WAS REPORTED THAT DURING CRANIOTOMY SURGERY, WHEN THE COMPREHENSIVE SURGICAL POWER SYSTEM WAS USED, THE POWER WAS INSUFFICIENT AND THE BONE FLAP COULD NOT BE REMOVED. THEREFORE, IT WAS REPLACED WITH A HAND DRILL FOR THE CRANIOTOMY, WHICH RESULTED IN A LARGER CRANIOTOMY BONE SEAM AND GREATER TRAUMA TO THE PATIENT. ADDITIONAL INFORMATION RECEIVED THAT THE POWER WAS INSUFFICIENT THROUGHOUT THE ENTIRE SURGERY. THE BUR WAS MOVING, THE DRILLING SPEED WAS NOT AS EXPECTED, AND IT COULDN'T WORK NORMALLY. NO ATTEMPTS HAVE BEEN MADE TO REPLACE OTHER ACCESSORIES.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 18409799 ↗

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