MAUDE Adverse Event Report: CONMED CORPORATION 2MM CYTOLOGY BRUSH RING HANDLE; PULMONARY CYTOLOGY BRUSH

Catalog Number 129R

Device Problem Break (1069)

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

Event Date 12/08/2016

Event Type  malfunction  

Manufacturer Narrative

The "used/damaged" 2mm bronchial cytology brush was not returned to conmed for evaluation of "the top of the plastic cannula was cut off." no visual evidence of this failure was made available.A failure analysis of the complaint device could not be completed therefore the reported failure cannot be verified; the complaint is unconfirmed.The device was manufactured 26-february-2016.A review of the device history for this lot found no noted discrepancies during the manufacturing process that could have caused or contributed to this reported incident.Of the lot containing (b)(4) units there were no other similar complaints received.A 2-year review of product history for this device family revealed only this 1 complaint for detachment of cannula tip.During this same 2-year time frame, over (b)(4) devices were sold worldwide, making the occurrence rate for this failure mode (b)(4) percent.To date, there have been no patient long term effects reported regarding any of the reported incidents.The conmed 2mm bronchial cytology brush is a single patient use brush for collecting samples using flexible bronchoscopes.The instructions for use (ifu) states: -in its straightened position, move the thumb ring back and forth, advancing and retracting the brush out of the distal end of the sheath.Retract the brush into the sheath until the thumb ring will not retract any further.The unit is then ready for insertion into the biopsy channel of an endoscope." not returned to manufacturer.

Event Description

As reported by the user facility, during a pulmonary cytology procedure on (b)(6) 2016, "during use of the device they found out that the top of the plastic cannula was cut off.Luckily they did not drop it into the pulm (lung) during the procedure." the patient was uninjured and the procedure was completed.To date no further information has been received regarding this incident and the device has not been returned for evaluation.This report is being filed with the potential for injury with recurrence.

Manufacturer Narrative

Device evaluation: one "damaged/used" 129r cytology brush was returned to conmed for evaluation of "during use of this device, they found out the top of the plastic cannula was cut off." the device was found to have detached piece of catheter trimming.A process analysis has been performed on the manufacturing line for the cytology brush assembly.The analysis determined that the distal end of the catheter is trimmed during assembly and the cut piece was not removed from the assembly.The catheter was incompletely trimmed due to a worn blade.The defect however was not detected during the 100% inspection of the lot.A group notification was performed with the operators to alert the personnel with regards to this complaint issue, the blade condition and inspection.A root cause investigation is not required at this time however this reported issue will continue to be monitored through the complaint system.

• Brand Name: 2MM CYTOLOGY BRUSH RING HANDLE
• Type of Device: PULMONARY CYTOLOGY BRUSH
• Manufacturer (Section D): CONMED CORPORATION; 525 french road; utica NY 13502 5994
• Manufacturer (Section G): CONSOLIDATED MEDICAL EQUIPMENT COMPANY; ave. alejandro dumas no. 11321; complejo industrial chihuahua; chihuahua, chihuahua CP 11 36; MX CP 1136
• Manufacturer Contact: kimber boss ; 525 french road; utica, NY 13502-5994 ; 3156243441
• MDR Report Key: 6228251
• MDR Text Key: 64027918
• Report Number: 3007305485-2016-00161
• Device Sequence Number: 1
• Product Code: FDX
• UDI-Device Identifier: 10653405052388
• UDI-Public: (01)10653405052388(17)210224(30)20(10)201602264
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K791668
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/06/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/24/2021
• Device Catalogue Number: 129R
• Device Lot Number: 201602264
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/06/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/26/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/26/2016
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1