MAUDE Adverse Event Report: COOK ENDOSCOPY FUSION BILIARY CYTOLOGY BRUSH; ENDOSCOPIC CYTOLOGY BRUSH

Model Number FS-CB-1.5-S

Device Problem Positioning Problem (3009)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/13/2015

Event Type  malfunction  

Event Description

Cytology brush wire came through channel.No harm.

• Brand Name: FUSION BILIARY CYTOLOGY BRUSH
• Type of Device: ENDOSCOPIC CYTOLOGY BRUSH
• Manufacturer (Section D): COOK ENDOSCOPY; 4900 bethania station road; wiston-salem NC 27105
• MDR Report Key: 5010440
• MDR Text Key: 23259461
• Report Number: 5010440
• Device Sequence Number: 1
• Product Code: FDX
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Report Date: 08/05/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Expiration Date: 06/01/2018
• Device Model Number: FS-CB-1.5-S
• Device Catalogue Number: G31525
• Device Lot Number: W3581152
• Other Device ID Number: 00827002315259(17)80600(10)
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/05/2015
• Device Age: 1 DY
• Event Location: Hospital
• Date Report to Manufacturer: 08/05/2015
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/18/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1