MAUDE Adverse Event Report: CONSOLIDATED MEDICAL EQUIPMENT 1MM CYTOLOGY BRUSH RING HANDLE

Catalog Number 133R

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/19/2019

Event Type  malfunction  

Manufacturer Narrative

The product is expected to be returned and the complaint investigation is ongoing.A supplemental and final report will be filed following the completion of the device evaluation and the complaint investigation.This issue will continue to be monitored through the complaint system to assure patient safety.

Event Description

The conmed representative reported on behalf of the facility that the 133r, 1mm sterile cytology brush, detached during a bronchoscopy on (b)(6) 2019.The brush was completely removed from the endobronchial location using biopsy forceps.The brush was inspected prior to use and no defects were found.The surgical team is familiar with this device.This report is being raised based on device malfunction with potential for injury upon reoccurrence.

Manufacturer Narrative

The device will not be returned for evaluation and no photographic evidence was provided therefore root cause cannot be identified.The manufacturing documents from the device history record have been reviewed with special attention to the manufacturing and inspection of the product.The product released for distribution were found to have met all specifications prior to shipment.This is the only complaint for this lot number and failure mode within the past two years.A two-year review of complaint history revealed there has been 1 complaint regarding 1 device for this device family and failure mode.During the same time frame 163,392 devices have been manufactured and shipped worldwide.Should all the complaint devices have been found confirmed, the rate of failure would be.000006 per the instructions for use, the user is advised the following; - prior to removal, pull the brush back into the distal end of the catheter and withdraw the instrument from the bronchoscope.- the specimen will now be protected from loss in the channel of the bronchoscope.- conmed encourages the inspection and/or test of all medical equipment prior to use to ensure all devices are functioning as expected.This issue will continue to be monitored through the complaint system to assure patient safety.

Manufacturer Narrative

Correction: due to the device having been returned: h6, type of investigation: removed 4114 and added 3331, 4109, 10, 4110 h6, investigation findings: removed 3221 and added 3252 h6, investigation conclusion: removed 4310 manufacturer narrative: received one 133r in opened original packaging.Lot number was verified.Performed a visual inspection, the wire for the brush is broke.This issue will continue to be monitored through the complaint system to assure patient safety.

• Brand Name: 1MM CYTOLOGY BRUSH RING HANDLE
• Type of Device: CYTOLOGY BRUSH
• Manufacturer (Section D): CONSOLIDATED MEDICAL EQUIPMENT; alejandro dumas ave, 11321; complejo industrial chihuahua; chihuahua, 31136 ; MX 31136
• MDR Report Key: 9439583
• MDR Text Key: 177266668
• Report Number: 3007305485-2019-00408
• Device Sequence Number: 1
• Product Code: FDX
• Combination Product (y/n): N
• PMA/PMN Number: K791668
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 11/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/13/2022
• Device Catalogue Number: 133R
• Device Lot Number: 201702144
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/01/2020
• Initial Date Manufacturer Received: 11/25/2019
• Initial Date FDA Received: 12/09/2019
• Supplement Dates Manufacturer Received: 01/22/2020; 11/12/2020
• Supplement Dates FDA Received: 01/23/2020; 11/18/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1