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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COOK INCORPORATED COLONOSCOPE CYTOLOGY BRUSH; ENDOSCOPIC CYTOLOGY BRUSH
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COOK INCORPORATED COLONOSCOPE CYTOLOGY BRUSH; ENDOSCOPIC CYTOLOGY BRUSH Back to Search Results
Model Number G22124
Device Problem Material Twisted/Bent (2981)
Patient Problem Insufficient Information (4580)
Event Date 09/27/2020
Event Type  malfunction  
Event Description
The patient was in the endoscopy lab undergoing an upper endoscopy with biopsy brushings.The physician requested an esophageal brushing.The first colonoscope cytology brush was inserted into the scope however it would not come out of the sheath.Upon inspection of the equipment by the scrub rn, the brush was found to be bent.A 2nd brush was inserted and was noted to be very stiff however no bending was noted.The physician was able to obtain biopsy with brush #2.
 
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Brand Name
COLONOSCOPE CYTOLOGY BRUSH
Type of Device
ENDOSCOPIC CYTOLOGY BRUSH
Manufacturer (Section D)
COOK INCORPORATED
750 daniels way
bloomington IN 47404
MDR Report Key10641250
MDR Text Key210203150
Report Number10641250
Device Sequence Number1
Product Code FDX
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 10/05/2020,10/01/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberG22124
Device Catalogue NumberCCB-7-240-3-S
Device Lot NumberW4366470
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA10/05/2020
Device Age1 YR
Event Location Hospital
Date Report to Manufacturer10/07/2020
Initial Date Manufacturer Received Not provided
Initial Date FDA Received10/07/2020
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
Patient Age23360 DA
Patient Weight86
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