MAUDE Adverse Event Report: COOK ENDOSCOPY CYTOMAX II DOUBLE LUMEN CYTOLOGY BRUSH; FDX, BRUSH, CYTOLOGY FOR ENDOSCOPE

Catalog Number	DLB-35-1.5-S
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/15/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation evaluation: a product evaluation was performed only by the pictures provided in response to this report, because the product said to be involved was not provided to cook for evaluation.Per the photos provided, we cannot complete a full evaluation.However, our evaluation of the photo provided does confirm the report.One photo shows the drive wire is broken on the distal end of the device with several kinks near the break.The break appears to be a clean break (no frayed wires) that is proximal to the bristles on the brush.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 conclusion: 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 indicate, "visually inspect with particular attention to kinks, bends and breaks.If an abnormalities is detected that would prohibit proper working conditions, do not use." prior to distribution, all cytomax ii double lumen cytology brushes are subjected to a visual inspection and functional testing to ensure 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.
Event or Problem Description
In preparation for a procedure, the user selected a cook cytomax ii double lumen cytology brush.The nurse tried to handle [advance] the sheath back and forth, but found that the brush was disconnected from the sheath.Another of the same device was used without a problem.The cytology procedure was completed successfully.A photo was received of the device.The cytology brush has broken and detached.
Additional Manufacturer Narrative
Investigation evaluation: our evaluation of the product said to be involved confirmed the report.The drive wire is broken on the distal end of the device with several kinks near the break.The break is a clean break (no frayed wires) and is proximal to the bristles on the brush, approximately 10.4 cm from the distal end of the device.There are numerous kinks throughout the catheter, drive wire, and handle cannula.A product-specific discrepancy that could have caused or contributed to this observation was not observed during our laboratory analysis.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 conclusion: a definitive cause for this observation could not be determined because the actual product handling conditions could not be duplicated in the laboratory setting.This limits our ability to conclusively determine a cause.The instructions for use indicate, "visually inspect with particular attention to kinks, bends and breaks.If an abnormalities is detected that would prohibit proper working conditions, do not use." prior to distribution, all cytomax ii double lumen cytology brushes are subjected to a visual inspection and functional testing to ensure 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: CYTOMAX II DOUBLE LUMEN CYTOLOGY BRUSH
• Common Device Name: FDX, BRUSH, CYTOLOGY FOR ENDOSCOPE
• Manufacturer (Section D): COOK ENDOSCOPY; 4900 bethania station rd; winston-salem NC 27105
• MDR Report Key: 6477177
• Report Number: 1037905-2017-00164
• Device Sequence Number: 19168501
• Product Code: FDX
• UDI-Device Identifier: 00827002226746
• UDI-Public: (01)00827002226746(17)190831(10)W3763597
• Combination Product (Y/N): N
• PMA/510(K) Number: K896318
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/08/2017

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
• Operator of Device: Health Professional
• Device Catalogue Number: DLB-35-1.5-S
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 03/15/2017
• Device Age: 7 MO
• Event Location: Hospital
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 03/16/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/10/2017
• Supplement Report FDA Received Date: 05/08/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1