Integrated Power Console 1898430Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00643169931398), received between Dec 19, 2022 and Dec 26, 2025 — classified as 1 injury, 8 malfunctions.

The most frequently reported specific device problem is “Device Remains Activated” (5 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 26, 2025Self-Activation or Keying; Self-Activation or Keying

  IT WAS REPORTED THAT THE FOOTSWITCH WAS RUNNING WITHOUT STEPPING ON THE PEDAL. THERE WAS NO KNOWN PATIENT IMPACT.

  Patient problems: Insufficient Information

  MAUDE report 23894813 ↗
• MalfunctionJun 10, 2025Unintended Power Up; Unintended Power Up

  IT WAS REPORTED THAT PRE-OP, FOOTSWITCH WAS ACTIVATING AUTOMATICALLY WITHOUT PRESSING IT. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22178534 ↗
• MalfunctionApr 4, 2025Device Remains Activated; Device Remains Activated

  IT WAS REPORTED THAT THE DEVICE RUNS CONTINUOUSLY. THERE WAS NO PATIENT IMPACT IN THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21770544 ↗
• InjuryOct 29, 2024Device Remains Activated; Device Remains Activated

  IT WAS REPORTED THAT DURING BRAINSURGERY, WHEN DRILLING IN THE SKULL BONE, ITEMS DID NOT STOP DRILLING WHEN SKULL BONE WAS BREACHED. SO DURA TEAR IN ALL THE 3 HOLES. THE SURGERY WAS EXTENDED FOR 30 MINUTES. THE PROCEDURE WAS COMPLETED WITH THE REPORTED PRODUCT. USER FIXED THE DURA WITH SPECIFIC PRODUCTS.

  Patient problems: Perforation

  MAUDE report 20558736 ↗
• MalfunctionOct 29, 2024Device Remains Activated; Device Remains Activated

  IT WAS REPORTED THAT INTRA OP, DEVICE STARTED TO RUN ON OWN AFTER 20MIN OF BEING ATTACHED TO IPC POWER CONSOLE. IPC FOOT PEDAL ATTACHED BUT NOT ENGAGED BY ANYONE/ANYTHING. NO CONSEQUENCES OR IMPACT TO PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20554913 ↗
• MalfunctionJul 4, 2024Unintended System Motion; Unintended System Motion

  IT WAS REPORTED THAT THE FOOT SWITCH ACTIVATES ITSELF AFTER A FEW MINUTES. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19674947 ↗
• MalfunctionJul 1, 2024Self-Activation or Keying; Use of Device Problem; Self-Activation or Keying; Use of Device Problem

  IT WAS REPORTED THAT POST-OP, UNTIMELY ACTIVATION OF IPC, PEDAL WAS INVOLVED. THE FOOT PEDAL WAS NOT WORKING PROPERLY. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19643227 ↗
• MalfunctionSep 12, 2023Device Remains Activated; Device Remains Activated

  IT WAS REPORTED THAT DURING USE THE DEVICE KEEPS SPINNING THE HANDPIECE WILL NOT STOP IT. NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17729202 ↗
• MalfunctionDec 19, 2022Intermittent Continuity; Device Remains Activated; Intermittent Continuity; Device Remains Activated

  IT WAS REPORTED BY HEALTH CARE PROFESSIONAL THAT INTRA-OP WHEN THIS FOOTSWITCH IS USED THE DRILL RUNS WITHOUT THE FOOTSWITCH BEING P RESSED(INTERMITTENT), A FOOTSWITCH FROM ANOTHER AVAILABLE SYSTEM WAS BORROWED AND THE SYSTEM WORKED CORRECTLY WITHOUT ANY ISSUES. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16006469 ↗

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