MAUDE Adverse Event Report: CONMED CONMED BLUE BULLET; ACCESSORIES, CLEANING BRUSHES, FOR ENDOSCOPE

Catalog Number	478C
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/03/2025
Type of Reportable Event	Malfunction
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 due to the receipt of a medwatch report (mw5177194) received on 23oct25.A search of the complaint system has not found a complaint reported for this device during this timeframe.The report was found to be written against the 478c, disposable scope valve & channel cleaning brush.The incident occurred on 3oct25.The report states that "the tip of small cleaning brush was dislodged into the egd scope.Conmed blue bullet disposable" there was no report of impact or injury to the patient.Per information received on 12nov25 it was reported that "the doctor was perfoming an egd and saw the brush in the abdomen: he used the basket to retrieve it through the scope." this report is being raised due to the reported malfunction with potential for injury upon reoccurrence.
Event or Problem Description
This complaint was created due to the receipt of a medwatch report (mw5177194) received on 23oct25.A search of the complaint system has not found a complaint reported for this device during this timeframe.The report was found to be written against the 478c, disposable scope valve & channel cleaning brush.The incident occurred on 3oct25.The report states that ¿the tip of small cleaning brush was dislodged into the egd scope.Conmed blue bullet disposable¿ there was no report of impact or injury to the patient.Per information received on 12nov25 it was reported that "the doctor was perfoming an egd and saw the brush in the abdomen - he used the basket to retrieve it through the scope.To my knowledge, the patient is in satisfactory conditions" and "there was not an extended stay for the patient.He went home as expected out patient." this report is being raised due to the reported malfunction with potential for injury upon reoccurrence.
Additional Manufacturer Narrative
Correction: section d3 was updated.Manufacturer narrative: neither the device nor photographic evidence was provided.Therefore, the reported event cannot 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: do not use if the product is kinked or damaged.We will continue to monitor per regulatory requirements to help ensure patient safety.

• Brand Name: CONMED BLUE BULLET
• Common Device Name: ACCESSORIES, CLEANING BRUSHES, FOR ENDOSCOPE
• Manufacturer (Section D): CONMED; 525 french rd; complejo industrial chihuahua; utica 13502
• Manufacturer (Section G): CONSOLIDATED MEDICAL EQUIPMENT COMPANY; ave. alejandro dumas 11321; complejo industrial chihuahua; chihuahua 31136 ; MX 31136
• Manufacturer Contact: robin drum ; 11311 concept blvd; largo, FL 33773 ; 8653881978
• MDR Report Key: 23680266
• Report Number: 3007305485-2025-00193
• Device Sequence Number: 18566779
• Product Code: MNL
• UDI-Device Identifier: 30653405050425
• UDI-Public: (01)30653405050425(17)290722(10)202407234
• Combination Product (Y/N): Y
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K946293
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date (Section B): 12/15/2025

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 Catalogue Number: 478C
• Device Lot Number: 202407234
• 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: 11/12/2025
• Supplement Date Received by Manufacturer: 12/10/2025
• Initial Report FDA Received Date: 12/01/2025
• Supplement Report FDA Received Date: 12/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/23/2024
• 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): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 72 YR
• Patient Sex: Male
• Patient Weight: 95 KG
• Patient Ethnicity: Non Hispanic