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Double-Header 00711609Recalls & reported problems

US Endoscopy · The Double Header Channel and Control Head Combo is a channel cleaning brush with nylon Flexi Brush attached to a flexible plastic sheath designed to safely remove debris from from the valve openings and dials of the control head of flexible endoscopes. · Class 1

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

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00724995184971), received between Sep 3, 2020 and Sep 3, 2020 — classified as 1 malfunction.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

  • Detachment of Device or Device Component1

Patient problems

  • No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • MalfunctionSep 3, 2020Detachment of Device or Device Component

    THE USER FACILITY REPORTED THAT THE BRUSH HEAD COMPONENT OF A DOUBLE HEADER CLEANING BRUSH BECAME DETACHED DURING CLEANING AND WAS RETAINED IN THE ENDOSCOPE CHANNEL. THE OCCLUSION OF THE CHANNEL WAS DETECTED DURING A PATIENT PROCEDURE, BUT THE BRUSH HEAD WAS NOT PUSHED INTO THE PATIENT. THE AFFECTED ENDOSCOPE WAS WITHDRAWN, AND THE PROCEDURE WAS COMPLETED WITH ANOTHER ENDOSCOPE. THERE WAS NO REPORT OF HARM TO THE PATIENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 10489812 ↗

Other ACCESSORIES, CLEANING BRUSHES, FOR ENDOSCOPE devices

All ACCESSORIES, CLEANING BRUSHES, FOR ENDOSCOPE devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.