MAUDE Adverse Event Report: WILSON-COOK MEDICAL INC CYTOMAX II DOUBLE LUMEN CYTOLOGY BRUSH; FDX ENDOSCOPIC CYTOLOGY BRUSH

Catalog Number DLB-35-1.5-S

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Foreign Body In Patient (2687)

Event Date 04/04/2022

Event Type  Injury  

Manufacturer Narrative

510k: k192908.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.The report was confirmed with the pictures provided.The photos were x-ray images which showed the broken brush tip inside of the patient.A picture of the lot number was not provided.Without the product or substantial evidence to contradict the complaint, it is considered confirmed based solely on the photos provided and statements describing the event.The device history record for the dlb-35-1.5-s was reviewed.The dlb-35-1.5-s device history record contains a nonconformance that could potentially be related to ¿product¿s tip was separated¿.The device goes through various inspections prior to leaving the facility.These inspections would have removed any nonconforming devices prior to distribution.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 including the following: "after obtaining specimen, retract brush into sheath." failure to retract the brush into the sheath may cause excess force on the device during removal from the scope.Prior to distribution, all fusion cytology brushes are subjected to a visual inspection and functional testing to ensure device integrity.A review of the possible device history records confirmed that the lots said to be involved met all manufacturing requirements prior to shipment.Corrective action: a review of the complaint history was conducted.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 for cell acquisition, the physician used a cytomax ii double lumen cytology brush.It was reported that the product's cytology brush tip was separated, detached, in the patient¿s hepatic duct.They used a variety of products to remove the tip, but failed to remove it and ended the procedure after they placed an enbd-7-liguory-rt nasal biliary drainage sets.The patient required additional procedures to remove the foreign body due to this occurrence, but were unsuccessful in removing the tip and remained inside the patient¿s body to pass naturally.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.

• Brand Name: CYTOMAX II DOUBLE LUMEN CYTOLOGY BRUSH
• Type of Device: FDX ENDOSCOPIC CYTOLOGY BRUSH
• Manufacturer (Section D): WILSON-COOK MEDICAL INC; 4900 bethania station rd; winston-salem NC 27105
• Manufacturer (Section G): COOK ENDOSCOPY; 4900 bethania station rd; winston-salem NC 27105
• Manufacturer Contact: sabrina o'brien ; 4900 bethania station rd; winston-salem, NC 27105 ; 3367440157
• MDR Report Key: 14273372
• MDR Text Key: 290669255
• Report Number: 1037905-2022-00199
• Device Sequence Number: 1
• Product Code: FDX
• UDI-Device Identifier: 10827002226743
• UDI-Public: (01)10827002226743(17)250105(10)W4552769
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/02/2022

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?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: DLB-35-1.5-S
• Device Lot Number: W4552769
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/04/2022
• Initial Date FDA Received: 05/04/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/05/2022
• 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 - OLYMPUS TJF 260V