MAUDE Adverse Event Report: WILSON-COOK MEDICAL INC. FUSION CYTOLOGY BRUSH; FDX, BRUSH, CYTOLOGY FOR ENDOSCOPE

Catalog Number FS-CB-1.5-S

Device Problem Migration or Expulsion of Device (1395)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/06/2014

Event Type  malfunction  

Event Description

During an endoscopy procedure, a cook fusion cytology brush was used.While i the middle of the bile duct, the physician advanced the brush over the wire guide and performed the brushing when the physician went to remove the bush from over the wire guide, the wire guide came out with guide and fusion cytology brush to complete the procedure with no further complications.A section of the device did not remain inside the pt's body.The pt did not require any additional procedures due to this occurrence.Accordance to the initial reporter, the pt did not experience any adverse effects due to this occurrence.

Manufacturer Narrative

Investigation evaluation: a product evaluation was not performed in response to this report because the product said to be involved was not provided to cook for evaluation.The report could not be confirmed.The device history record for the lot number said to be involved was reviewed.A discrepancy or anomaly was not observed with the product that was released for distribution.Investigation conclusions: we could not conduct a complete investigation because the product said to be involved was not returned for evaluation.A definitive cause for the reported observation could not be determined.The instructions for use caution the user that the wire guide diameter and the inner lumen of the brush must be compatible.The instructions for use state, "for best results, wire guide should be kept wet" and if using a fr brush with intra ductal exchange port and pre-positioned short wire "advance disengaged wire guide to maintain ductal access." prior to distribution, all fusion cytology brushes are subjected to a visual inspection and functional test to ensure proper workability and device integrity.A review of the device history record confirmed that the lot said to be involved met all manufacturing requirements prior to shipment.Corrective action: a review of the complaint history was conducted and this represents an isolated occurrence.The likelihood of occurrence is considered rare.Corrective action is not warranted at this time based on the quality engineering risk assessment.Quality assurance will continue to monitor for complaint trends and reassess the risk assessment results as post market feedback continues to become available.

• Brand Name: FUSION CYTOLOGY BRUSH
• Type of Device: FDX, BRUSH, CYTOLOGY FOR ENDOSCOPE
• Manufacturer (Section D): WILSON-COOK MEDICAL INC.; winston-salem NC 27105
• Manufacturer Contact: scottie fariole, manger ; 4900 bethania station rd; winston-salem, NC 27105 ; 3367440157
• MDR Report Key: 3752940
• MDR Text Key: 4464823
• Report Number: 1037905-2014-00036
• Device Sequence Number: 1
• Product Code: FDX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K040324
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 01/07/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/05/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/07/2016
• Device Catalogue Number: FS-CB-1.5-S
• Device Lot Number: W3354112
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 01/06/2014
• Device Age: 2 MO
• Event Location: Hospital
• Date Manufacturer Received: 01/07/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/07/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: ENDOSCOPE (UNKNOWN TYPE); WIRE GUIDE (UNKNOWN TYPE)