MAUDE Adverse Event Report: WILSON-COOK MEDICAL INC FUSION CYTOLOGY BRUSH; FDX ENDOSCOPIC CYTOLOGY BRUSH

Catalog Number FS-CB-1.5-S

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Foreign Body In Patient (2687)

Event Date 10/16/2023

Event Type  Injury  

Event Description

During an endoscopic retrograde cholangiopancreatography, the physician used a cook fusion cytology brush.It was reported [that] when the user brushed the tumor two times, the tip of the brush was disconnected in chd at the second time.He tried to use [cook products] mb5-2x4-8 and fs-qeb-b but couldn't take it [detached brush tip] out and tip run to ihd.Finally, he placed an oacl plastic stent.A section of the detached cytology brush tip remained inside the patient¿s body.A plastic stent was placed.

Manufacturer Narrative

Section h: pma/510(k):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 device during use, before and after the brush tip detached 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 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.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.

• Brand Name: FUSION 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: 18124890
• MDR Text Key: 327993283
• Report Number: 1037905-2023-00561
• Device Sequence Number: 1
• Product Code: FDX
• UDI-Device Identifier: 10827002315256
• UDI-Public: (01)10827002315256(17)260213(10)W4700779
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/13/2023

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: FS-CB-1.5-S
• Device Lot Number: W4700779
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/13/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/13/2023
• 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 MAKE AND MODEL
• Patient Outcome(s): Required Intervention
• Patient Age: 71 YR
• Patient Sex: Female
• Patient Weight: 65 KG