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

Catalog Number	130
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	10/25/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device is not expected to be returned for evaluation and review.However, the complaint investigation is not complete at this time.A supplemental and final report will be filed following the completion of the complaint investigation.We will continue to monitor per regulatory requirements to help ensure patient safety.
Event or Problem Description
This complaint was created by the finding of maude report number (b)(4) on 4feb2025.The current complaint database has been researched for this event and there were no findings.The report was found to be written against a 130, disp microbiology brush,ø1 mm,1.8 mm working dia,110 cm l, device.The date of the procedure was (b)(6) 2024.The reporter remained anonymous.The report states, ¿brushing performed during bronchoscopy, while the physician was brushing, the brush broke off into the lung.The physician attempted to remove the object, however it moved out of view.During brush insertion into the scope, there was no resistance or kinking.Physician requested a stat chest radiograph, the x-ray could not visualize the brush.¿ there was no report of hospitalization for the patient due to the incident.The reporter remained anonymous; therefore, conmed is unable to request further information.This report is being raised due to the reported injury of component left in patient.
Event or Problem Description
This complaint was created by the finding of maude report number 20950862 on 4feb25.The current complaint database has been researched for this event and there were no findings.The report was found to be written against a 130, disp microbiology brush, ø1 mm,1.8 mm working dia,110 cm l, device.The date of the procedure was (b)(6) 2024.The reporter remained anonymous.The report states, ¿brushing performed during bronchoscopy, while the physician was brushing, the brush broke off into the lung.The physician attempted to remove the object; however it moved out of view.During brush insertion into the scope, there was no resistance or kinking.Physician requested a stat chest radiograph; the x-ray could not visualize the brush.¿ there was no report of hospitalization for the patient due to the incident.The reporter remained anonymous; therefore, conmed is unable to request further information.This report is being raised due to the reported injury of component left in patient.
Additional Manufacturer Narrative
Neither the device nor photographic evidence was provided.Therefore, the reported event can not be verified.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.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 a total of one complaint, regarding one device, for this device family and failure mode.During this same time frame (b)(4) 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 per regulatory requirements to help ensure patient safety.

• Brand Name: CONMED
• Common Device Name: BRUSH, BIOPSY, BRONCHOSCOPE (NON-RIGID)
• Manufacturer (Section D): CONSOLIDATED MEDICAL EQUIPMENT; alejandro dumas ave, 11321; complejo industrial chihuahua; chihuahua, 31136 ; MX 31136
• Manufacturer (Section G): CONSOLIDATED MEDICAL EQUIPMENT; alejandro dumas ave, 11321; complejo industrial chihuahua; chihuahua, 31136 ; MX 31136
• Manufacturer Contact: john berga ; 11311 concept blvd.; largo, FL 33773 ; 7273995358
• MDR Report Key: 21420008
• Report Number: 3007305485-2025-00019
• Device Sequence Number: 7764209
• Product Code: BTG
• UDI-Device Identifier: 10653405052340
• UDI-Public: (01)10653405052340(17)280704(10)202307064
• Combination Product (Y/N): N
• PMA/510(K) Number: K820771
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/17/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 130
• Device Lot Number: 202307064
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/04/2025
• Supplement Date Received by Manufacturer: 03/04/2025; 04/14/2025
• Initial Report FDA Received Date: 02/20/2025
• Supplement Report FDA Received Date: 03/26/2025; 04/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/06/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 62 YR
• Patient Sex: Unknown
• Patient Ethnicity: Non Hispanic