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DOUBLE ENDED CHANNEL BRUSH 100402Recalls & reported problems

Medivators Inc. · DOUBLE ENDED CHANNEL BRUSH · Class 1

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports
3
Deaths reported
0
Injuries reported
1
Recalls naming it
0

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00677964060632), received between Nov 11, 2016 and Oct 13, 2022 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Connection Problem” (1 report).

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 18, 2026.

Most reported problems

Device problems

  • Adverse Event Without Identified Device or Use Problem1
  • Connection Problem1
  • Use of Device Problem1

Patient problems

  • No Known Impact Or Consequence To Patient2
  • No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

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

  • MalfunctionOct 13, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    THE USER FACILITY REPORTED VIA MEDWATCH (MW5111956) THAT THEIR ENDOSCOPE CLEANING BRUSH IS NOT EFFECTIVELY CLEANING THE SCOPE. NO REPORT OF PATIENT HARM OR INJURY.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 15598351 ↗
  • InjuryAug 31, 2018Use of Device Problem; Use of Device Problem

    THE FACILITY REPORTED THE TIP OF A DOUBLE ENDED CHANNEL BRUSH BROKE INSIDE AN ENDOSCOPE AS STAFF WAS CLEANING IT. IT FELL INSIDE A PATIENT DURING THE SUBSEQUENT PATIENT PROCEDURE AND THE PHYSICIAN RETRIEVED THE BRUSH TIP WITH A ROTH NET. NO ADVERSE EVENT WAS REPORTED.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 7837888 ↗
  • Nov 11, 2016Connection Problem; Connection Problem

    A FACILITY REPORTED THAT AN ENDOSCOPE CHANNEL BRUSH END WAS REPORTED STUCK IN THE SUCTION CHANNEL IN A PENTAX EGD SCOPE AND WAS NOT DISCOVERED TILL AFTER THE ENDOSCOPE WAS USED ON A PATIENT.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 6097643 ↗

Other Accessories, Cleaning Brushes, For Endoscope devices

All Accessories, Cleaning Brushes, For Endoscope devices →

Sources and updates

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