MAUDE Adverse Event Report: CONSOLIDATED MEDICAL EQUIPMENT COMPANY 2MM STERILE DISP. CYTOL.; ENDOSCOPIC CYTOLOGY BRUSH

Model Number	129R
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/20/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is not being returned and no photograph evidence was provided.Therefore, the reported failure could 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.(b)(4).Per the instructions for use, the user is advised the following: before advancing the instrument through the flexible bronchoscope, retract brush into catheter by pulling the brush handle back approximately 5 cm or until brush tip is flush with distal end of catheter.The catheter and protective tip protect the bristles from some of the contaminating organisms that may be picked up while passing it through the flexible bronchoscope.This issue will continue to be monitored through the complaint system to assure patient safety.
Event or Problem Description
The customer reported that the device, 129r, was being used on (b)(6) 2021 during a bronchoscopy procedure and when they ¿deployed the brush it broke off in the patient.We were able to retrieve the brush out of the patient.¿ there was no report of impact or injury to the patient.The procedure was completed.This report is being raised on the basis of malfunction with potential for injury upon reoccurrence.

• Brand Name: 2MM STERILE DISP. CYTOL.
• Common Device Name: ENDOSCOPIC CYTOLOGY BRUSH
• Manufacturer (Section D): CONSOLIDATED MEDICAL EQUIPMENT COMPANY; ave. alejandro dumas 11321; complejo industrial chihuahua; chihuahua 31136 ; MX 31136
• MDR Report Key: 12646644
• Report Number: 3007305485-2021-00391
• Device Sequence Number: 4557845
• Product Code: FDX
• UDI-Device Identifier: 10653405052388
• UDI-Public: (01)10653405052388(17)260516(10)202105174
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K791668
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/18/2021

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: 05/16/2026
• Device Model Number: 129R
• Device Catalogue Number: 129R
• Device Lot Number: 202105174
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/23/2021
• Initial Report FDA Received Date: 10/18/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1