MAUDE Adverse Event Report: COOK INCORPORATED FUSION; ENDOSCOPIC CYTOLOGY BRUSH

Model Number G31525

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/23/2021

Event Type  malfunction  

Event Description

Cook fusion cytology brush was used to brush biliary duct to check for abnormal cells.The flexible tip of the brush broke off in the patients biliary duct.Brush was pulled out of scope and sent to cytology.Retrieval balloon was then used to go inside biliary duct and sweep out tip of brush.Forceps were used to grab the tip and pull it out of patient.Tip of brush was then packaged in its original package and sent to device manufacturer to be examined.Physician then did another sweep of the duct and did a cholangiogram to ensure there was no perforation of the duct.Manufacturer response for fusion cytology brush, (brand not provided) (per site reporter): unknown.

• Brand Name: FUSION
• Type of Device: ENDOSCOPIC CYTOLOGY BRUSH
• Manufacturer (Section D): COOK INCORPORATED; 750 daniels way; bloomington IN 47404
• MDR Report Key: 12553823
• MDR Text Key: 274011089
• Report Number: 12553823
• Device Sequence Number: 1
• Product Code: FDX
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/30/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: G31525
• Device Catalogue Number: FS-CB-1.5-S
• Device Lot Number: W4476479
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/10/2021
• Event Location: Hospital
• Date Report to Manufacturer: 09/30/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 26280 DA
• Patient Weight: 66