NA 1898430Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00613994436405), received between Apr 28, 2017 and Feb 19, 2024 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Self-Activation or Keying” (6 reports).

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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 19, 2024Self-Activation or Keying; Material Split, Cut or Torn; Self-Activation or Keying; Material Split, Cut or Torn

  IT WAS REPORTED THAT PRE-OP, THE FOOT PEDAL GRIP TAPE WAS LIFTING FROM THE PEDAL THE PEDAL ACTIVATES WHEN NOT BEING PRESSED. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18730576 ↗
• MalfunctionJan 8, 2024Device Remains Activated; Device Remains Activated

  IT WAS REPORTED THAT HANDPIECE WOULD NOT STOP. THERE IS NO KNOWN PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18464236 ↗
• MalfunctionJun 30, 2023Self-Activation or Keying; Self-Activation or Keying

  IT WAS REPORTED THAT DURING SURGERY AND DURING BIOMED TESTING, THE FOOT PEDAL WOULD ACTIVATE THE HAND PIECE ON ITS OWN AND DISPLAYED  CODE 17 ERROR ON THE SCREEN. DURING BIOMED TESTING, AFTER TURNING ON THE DEVICE, THE HAND-PIECE WAS LEFT ON THE WORK BENCH AT REST AND THE HAND-PIECE ACTIVATED ON ITS OWN (WITHOUT STEPPING ON THE FOOT SWITCH) AFTER A COUPLE MINUTES OF INACTIVITY. THE ISSUE WAS NOT DISCOVERED PRIOR TO USE ON THE PATIENT AND THE THE USER DID NOT ACTIVATE THE DEVICE IN ERROR. NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17236194 ↗
• MalfunctionJan 12, 2018Self-Activation or Keying; Self-Activation or Keying

  THE CUSTOMER REPORTED THE HANDPIECE STALLED, THEN OPERATED AT LOW RPM WHEN THE FOOT SWITCH WAS NOT PRESSED. THE CONSOLE (EC300) WAS USED WITH THE FOOT SWITCH WHEN THE EVENT OCCURRED. THERE WAS NO PATIENT IMPACT. REPORT 1 OF 2 - FOOT SWITCH.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7187552 ↗
• MalfunctionNov 14, 2017Self-Activation or Keying; Self-Activation or Keying

  THE FACILITY REPORTED THAT THE FOOT PEDAL IS ACTIVATING HANDPIECES WHEN IT IS NOT BEING PRESSED ON. THE FAULT WAS CONFIRMED WITH MULTIPLE UNITS. A BACKUP FOOT PEDAL WAS USED FOR THIS PROCEDURE. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7028634 ↗
• MalfunctionSep 15, 2017Self-Activation or Keying; Self-Activation or Keying

  THE CUSTOMER REPORTED THAT DURING SETUP, WHEN THE HANDPIECE WAS AT REST/INACTIVE AND THE FOOT SWITCH WAS RELEASED, THE HANDPIECE TURNED ON BY ITSELF. ALSO, WHEN USING THE FOOT SWITCH, THERE WAS NO ACTION FROM THE CONSOLE. THERE WAS NO PATIENT IMPACT OR INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6868407 ↗
• MalfunctionApr 28, 2017Self-Activation or Keying; Self-Activation or Keying

  IT WAS REPORTED THAT AN ATTACHMENT RUNS WHEN THE FOOT SWITCH IS NOT PRESSED. THERE WAS NO PATIENT IMPACT OR INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6530758 ↗

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