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 08/23/2021

Event Type  Injury  

Manufacturer Narrative

510(k): k192908.Investigation evaluation: our laboratory evaluation of the product said to be involved confirmed the report based on the condition of the returned device.Only the detached coil spring of the device was returned; the brush, drive wire, and handle were not included and therefore a full evaluation was not possible.The returned tip is approximately 1.6 cm in length, which is within specification.Solder is present at the proximal end of the tip, and the weld ball is present on the distal end of the tip.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 the reported observation could not be determined because the condition of the product said to be involved prohibited a complete evaluation.Only the coil spring tip was returned for 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 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 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 a cytology procedure, the physician used a cook fusion cytology brush.The atraumatic spring tip broke off inside the bile duct while brushing.They used an ercp extraction balloon to remove the tip from the duct.Biopsy forceps was used to get the tip out of the patient.They were done using the device at that point so no other product was needed.A section of the device did not remain inside the patient¿s body.The detached portion was retrieved with an extraction balloon and biopsy forceps.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.

Event Description

During a cytology procedure, the physician used a cook fusion cytology brush.The atraumatic spring tip broke off inside the bile duct while brushing.They used an ercp extraction balloon to remove the tip from the duct.Biopsy forceps was used to get the tip out of the patient.They were done using the device at that point so no other product was needed.A section of the device did not remain inside the patient¿s body.The detached portion was retrieved with an extraction balloon and biopsy forceps.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.Medwatch (b)(4) was received and was determined to be related to this event.The following was reported: cook fusion cytology brush was used to brush biliary duct to check for abnormal cells.The flexible tip of the brush broke off in the patient's biliary duct.Brush was pulled out of scope and sent to cytology.Retrieval balloon was then used to go inside the biliary duct and sweep out tip of burhs.Forceps were used to grab the tip and pull it out of patient.Tip of brush was then packaged in its original package and sent to device manufacturer to be examined.Physician then did another sweep of the duct and did a cholangiogram to ensure there was no perforation of the duct.

• 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
• MDR Report Key: 12497938
• MDR Text Key: 274938888
• Report Number: 1037905-2021-00514
• Device Sequence Number: 1
• Product Code: FDX
• UDI-Device Identifier: 10827002315256
• UDI-Public: (01)10827002315256(17)240528(10)W4476479
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 09/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/20/2021
• 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: W4476479
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/27/2021
• Date Manufacturer Received: 08/23/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: OLYMPUS ENDOSCOPE, UNKNOWN MAKE OR MODEL.
• Patient Outcome(s): Required Intervention
• Patient Age: 72 YR
• Patient Weight: 66