Cook G22108Recalls & reported problems
Cook Incorporated · Colonoscope Cytology Brush · Class 2
- 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 00827002221086), received between Aug 16, 2022 and Aug 16, 2022 — classified as 1 malfunction.
The most frequently reported specific device problem is “Break” (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
- Break1
- Difficult to Open or Close1
Patient problems
- Insufficient Information1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 16, 2022Break; Difficult to Open or Close
COLONOSCOPY CYTOLOGY BRUSH WOULD NOT OPEN, HANDLE BROKEN, SUPPLY WASTED, HAD TO USE SECOND BRUSH TO OBTAIN SPECIMEN. FDA SAFETY REPORT ID# (B)(4).
Patient problems: Insufficient Information
MAUDE report 15242186 ↗
Other endoscopic cytology brush devices
- RX Cytology Brush M00545000Boston Scientific Corporation · endoscopic cytology brush161 reports
- superDimension AKI00100-01Covidien LP · endoscopic cytology brush5 reports
- Infinity 00711652US Endoscopy · endoscopic cytology brush4 reports
- CytoMax II G22674Cook Incorporated · endoscopic cytology brush4 reports
- superDimension SDNB2000Covidien LP · endoscopic cytology brush1 death3 reports
- Hobbs Microbiology Brush 4310Hobbs Medical, Inc. · Endoscopic Cytology Brush2 reports
- Infinity 00711499US Endoscopy · endoscopic cytology brush2 reports
- Infinity 00711653US Endoscopy · endoscopic cytology brush2 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.