MAUDE Adverse Event Report: COOK ENDOSCOPY CYTOMAX II DOUBLE LUMEN CYTOLOGY BRUSH; FDX ENDOSCOPIC CYTOLOGY BRUSH

Model Number G22674

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/25/2019

Event Type  malfunction  

Manufacturer Narrative

Occupation: non-healthcare professional.Investigation evaluation: our laboratory evaluation of the product said to be involved could not confirm the report as it was described because all the device components were not included in the return (the handle, drive wire, and brush were not returned) and because the pouch was returned opened.Due to the condition of the returned device (no brush/drive wire/handle), we were unable to conduct a full evaluation.The sheath contained brownish clear fluid.An unidentified brownish substance was found in the purple hub.The tip of the sheath appeared deformed and to be covered in a brownish clear substance.Although the brush, drive wire, and handle are missing from the device, we cannot confirm if the device was incorrectly manufactured, nor if the missing component detached, due to the packaging being opened prior to returning to cook for evaluation.No other anomalies were detected with the device.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.The appropriate amount of material is documented on the device history record.According to our records, the appropriate quantity was included during manufacture and packaging of this lot.Investigation conclusion: a definitive cause for the reported observation could not be determined because the condition of the product said to be involved prohibited a complete evaluation.A discrepancy or anomaly that could have contributed to the reported observation was not observed during our laboratory analysis of the returned product.The instructions for use (ifu) states, "visually inspect with particular attention to kinks, bends and breaks.If an abnormality is detected that would prohibit proper working conditions, do not use." the report indicates that the device was not checked prior to insertion into the endoscope.Prior to distribution, all cytomax ii double lumen cytology brushes are subjected to a visual inspection and functional test to ensure proper workability and device integrity.The handle is manipulated ensuring that the brush fully extends and retracts from sheath.The visual inspection includes inspecting for kinks in the sheath.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 Description

During an endoscopic procedure, the physician used a cook cytomax ii double lumen cytology brush.The user opened the package and advanced the device into the endoscope.[the user] found that there was no brush on the device, only the sheath of the catheter.Additional information was received on 09-jul-2019: only the clear outer plastic sheath was with the device and the inner wire with the brush was not with the device.Additional information was received on 11-jul-2019: the device was not checked prior to insertion to the endoscope.Our attempts to collect additional information regarding patient outcome were unsuccessful.The location of the missing portion of the device is unknown.While the complainant did not specify if the patient experienced any adverse effects or required additional medical procedures due to this event, the information able to be collected does not reasonably suggest the patient was adversely impacted.

• Brand Name: CYTOMAX II DOUBLE LUMEN CYTOLOGY BRUSH
• Type of Device: FDX ENDOSCOPIC CYTOLOGY BRUSH
• Manufacturer (Section D): COOK ENDOSCOPY; 4900 bethania station rd; winston-salem NC 27105
• Manufacturer (Section G): COOK ENDOSCOPY; 4900 bethania station rd; winston-salem NC 27105
• Manufacturer Contact: scottie fariole ; 4900 bethania station rd; winston-salem, NC 27105 ; 3367440157
• MDR Report Key: 8804305
• MDR Text Key: 151884182
• Report Number: 1037905-2019-00398
• Device Sequence Number: 1
• Product Code: FDX
• UDI-Device Identifier: 00827002226746
• UDI-Public: (01)00827002226746(17)220325(10)W4195508
• Combination Product (y/n): N
• Reporter Country Code: CN
• PMA/PMN Number: K896318
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/25/2019

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 Expiration Date: 03/25/2022
• Device Model Number: G22674
• Device Catalogue Number: DLB-35-1.5-S
• Device Lot Number: W4195508
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/16/2019
• Initial Date Manufacturer Received: 06/25/2019
• Initial Date FDA Received: 07/18/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/03/2019
• 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
• Patient Age: 70 YR
• Patient Weight: 65