MAUDE Adverse Event Report: AVANOS MEDICAL INC. DUAL-ENDED CLEANING BRUSH; DH ENDOSCOPY ACCESSORIES

Model Number	60218
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product involved in the report has been returned and is being processed for evaluation.A review of the device history record and udi number are in-progress.All information reasonably known as of 27-dec-2024 has been included in this health authority report.Should additional information be obtained, a follow-up health authority report will be provided.The information provided by avanos medical, inc.Represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to avanos medical, inc.Avanos medical, inc.Has no independent knowledge of the event reported but is relaying the information that was provided by the user facility where the incident occurred.This product incident is documented in the avanos medical, inc.Complaint database and identified as complaint (b)(4).This information is submitted pursuant to 21cfr803, in compliance with the medical device reporting requirement and should not be considered to be an admission that an avanos medical, inc.Product is defective or caused serious injury.
Event or Problem Description
It was reported the "small 5.0mm diameter brush head has detached and lodged inside our gastroscope.We do not know how long the brush head was stuck inside the scope (thinking a day) since when we take biopsies the forceps diameter will push out any foreign objects.We used forceps 2 -days ago so i'm assuming it was from reprocessing after that day use.We located the brush head after the scope failed to suction, the scope was inside of a patient, so we are monitoring for infection." additional information received 06-dec-2024 stated the user facility did not know how long the brush head was stuck inside the scope (thinking a day) since when [they] take biopsies the forceps diameter will push out any foreign objects.".
Additional Manufacturer Narrative
The device history record for the reported lot number, 30330309, in this complaint was reviewed and the material was produced according to the manufacturing procedures and met the quality requirements.The sample was evaluated.One detached distal cleaning brush was received.The remaining portion of the product was not returned.The product packaging was not returned.The item did not contain a lot number identification.After cleaning and decontamination, the sample was examined in a well-lit area.The overall length measured approximately 3cm.The yellow tip was attached and appeared undamaged.The brush bristles appeared to be undamaged.The sample was examined under magnification.There was jagged tearing of the gray sheath which covered the wire.The end of the twisted wire appeared to be relatively evenly severed.The yellow tip exhibited what appeared to be excess adhesive on the outer surface.This substance protruded from the surface of the tip.The root cause of the reported issue has not been conclusively determined.All information reasonably known as of 08-jul-2025 has been included in this health authority report.Should additional information be obtained, a follow-up health authority report will be provided.The information provided by avanos medical, inc.Represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to avanos medical, inc.Avanos medical, inc.Has no independent knowledge of the event reported but is relaying the information that was provided by the user facility where the incident occurred.This product incident is documented in the avanos medical, inc.Complaint database and identified as (b)(4).This information is submitted pursuant to 21cfr803, in compliance with the medical device reporting requirement and should not be considered to be an admission that an avanos medical, inc.Product is defective or caused serious injury.

• Brand Name: DUAL-ENDED CLEANING BRUSH
• Common Device Name: DH ENDOSCOPY ACCESSORIES
• Manufacturer (Section D): AVANOS MEDICAL INC.; 5405 windward parkway; alpharetta GA 30004
• Manufacturer (Section G): AVENT SA DE R.L. DE C.V. (AVENT 1); circuito industial no.40; colonia obrera; nogales, cp
• Manufacturer Contact: tamara cardona ; 5405 windward parkway; alpharetta, GA 30004 ; 4704485487
• MDR Report Key: 21029000
• Report Number: 9611594-2024-00301
• Device Sequence Number: 17161382
• Product Code: MNL
• UDI-Device Identifier: 10350770926473
• UDI-Public: (01)10350770926473(240)120000878(11)240611(10)30330309
• Combination Product (Y/N): N
• Initial Reporter State: HI
• Initial Reporter Country: US
• PMA/510(K) Number: UNKNOWN
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/08/2025

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 Model Number: 60218
• Device Catalogue Number: 60218
• Device Lot Number: 30330309
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/26/2024
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/05/2024
• Supplement Date Received by Manufacturer: 06/11/2025
• Initial Report FDA Received Date: 12/27/2024
• Supplement Report FDA Received Date: 07/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/01/2024
• 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: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown