MAUDE Adverse Event Report: COOK ENDOSCOPY 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 09/23/2021

Event Type  Injury  

Manufacturer Narrative

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 broken brush tip inside of the patient.One of the provided photos showed the removal of the brush tip using an extraction basket.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 records for the possible lot numbers said to be involved were 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 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 and this represents an unusual 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 the endoscopic retrograde cholangiapancreatograpy (ercp), the physician used a fusion cytology brush.The brush was used to acquire some specimens for the diagnosis.First in the right duct, with no problem, then in the left duct, the metal tip of the brush bent (per the user, "probably due to the fact that it encountered the stenosis and did not make it to follow the wire and pass the stenosis") and broke.Under x-ray the user noted that the radiopaque metal tip detached from the brush and remained inside the left hepatic duct, below the stenosis.The metal tip was then retrieved from the bile duct thanks to an extraction balloon (after multiple trials with both the balloon and a dormia basket).The broken tip of the device remained in the patient¿s body and was removed with a dormia extraction basket and an extraction balloon.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.

• Brand Name: FUSION 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: sabrina o'brien ; 4900 bethania station rd; winston-salem, NC 27105 ; 3367440157
• MDR Report Key: 12692859
• MDR Text Key: 278325374
• Report Number: 1037905-2021-00588
• Device Sequence Number: 1
• Product Code: FDX
• Combination Product (y/n): N
• Reporter Country Code: IT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/25/2021
• 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: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/27/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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 Outcome(s): Required Intervention
• Patient Age: 81 YR
• Patient Weight: 85