MAUDE Adverse Event Report: CONSOLIDATED MEDICAL EQUIPMENT COMPANY CONMED; BRUSH, BIOPSY, BRONCHOSCOPE (NON-RIGID)

Catalog Number	130
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/27/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported device has been returned to conmed; however, the complaint investigation has not been completed.A supplemental and final report will be filed following the completion of the complaint investigation.We will continue to monitor for trends through the complaint system to assure patient safety.
Event or Problem Description
The customer reported that the 130, disp microbiology brush,ø1 mm,1.8 mm working dia,110 cm l was being used on (b)(6) 2024 during an unknown procedure when it was reported ¿when we had the brush into the scope into the airway i pushed the brush tip out and this soft bristle like object was pushed out into the airway, upon inspection, it was the brush tip that came off the brush.No harm was caused.¿.Further assessment questioning found that no further information was available, however, all pieces were returned, and the device was intact.There was no report of injury, medical intervention, or extended hospitalization for the patient.This report is being raised on the basis of malfunction with potential for injury upon reoccurrence.
Additional Manufacturer Narrative
Received one 130 in opened original packaging.Lot number was verified.Performed a visual inspection, there were no obvious signs of abnormalities or defects.No evidence of missing bristles was observed and the brush tip was intact.Performed a functional inspection and the brush deploys and retracts as intended.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 was found to have met all specifications prior to shipment.A 2 year lot history review shows a total of 1 device for the reported lot number and failure mode.A two-year review of complaint history revealed there has been a total of 1 complaint, regarding 1 device, for this device family and failure mode.During this same time frame 37,370 devices have been manufactured and shipped worldwide.Should all the complaint devices have been found confirmed for this reported failure, the rate of failure would be (b)(4).We will continue to monitor for trends through the complaint system to assure patient safety.
Event or Problem Description
The customer reported that the 130, disp microbiology brush,ø1 mm,1.8 mm working dia,110 cm l was being used on (b)(6) 2024 during an unknown procedure when it was reported ¿when we had the brush into the scope into the airway i pushed the brush tip out and this soft bristle like object was pushed out into the airway, upon inspection, it was the brush tip that came off the brush.No harm was caused.¿.Further assessment questioning found that no further information was available, however, all pieces were returned, and the device was intact.There was no report of injury, medical intervention, or extended hospitalization for the patient.This report is being raised on the basis of malfunction with potential for injury upon reoccurrence.

• Brand Name: CONMED
• Common Device Name: BRUSH, BIOPSY, BRONCHOSCOPE (NON-RIGID)
• Manufacturer (Section D): CONSOLIDATED MEDICAL EQUIPMENT COMPANY; ave. alejandro dumas 11321; complejo industrial chihuahua; chihuahua 31136 ; MX 31136
• Manufacturer (Section G): CONSOLIDATED MEDICAL EQUIPMENT COMPANY; ave. alejandro dumas 11321; complejo industrial chihuahua; chihuahua 31136 ; MX 31136
• Manufacturer Contact: samantha dewberry ; 525 french road; utica, NY 13502 ; 3152230184
• MDR Report Key: 20268287
• Report Number: 3007305485-2024-00138
• Device Sequence Number: 12572944
• Product Code: BTG
• UDI-Device Identifier: 10653405052340
• UDI-Public: (01)10653405052340(17)251130(10)202012014
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K820771
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/30/2024

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
• Operator of Device: Health Professional
• Device Expiration Date: 11/30/2025
• Device Catalogue Number: 130
• Device Lot Number: 202012014
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/16/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/27/2024
• Supplement Date Received by Manufacturer: 10/04/2024
• Initial Report FDA Received Date: 09/20/2024
• Supplement Report FDA Received Date: 10/30/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/01/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Patient Ethnicity: Non Hispanic