MAUDE Adverse Event Report: UNITED STATES ENDOSCOPY GROUP, INC. DOUBLE HEADER CHANNEL AND CONTROL HEAD COMBO; CLEANING BRUSH

Model Number	00711609
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/29/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Following the procedure, the detached brush head was removed and identified as the occlusion of the channel.The device subject of this event is not available for evaluation.The user facility provided a photograph of the detached brush head; however, without a returned device, the cause of the reported event could not be determined.The device history record was reviewed and confirmed the device lot was manufactured to specification.There have been no other complaints associated with this lot.The instructions for use include the following statements: "original equipment manufacturer's guidelines regarding the care and cleaning of individual endoscope channels must be reviewed prior to the use of any cleaning brush.Dispose of the cleaning brush after initial use.The mechanical attachment of the brush(es) to the plastic sheath cannot be guaranteed to be reliable or secure following initial use.If the channel(s) are known to be occluded or resistance is met in attempting to pass the brush through the endoscope, do not force the cleaning brush through the endoscope, as this may result in damage to the channel." steris endoscopy has offered in-service training to the user facility; however, the facility has declined.No further issues have been reported.
Event or Problem Description
The user facility reported that the brush head component of a double header cleaning brush became detached during cleaning and was retained in the endoscope channel.The occlusion of the channel was detected during a patient procedure, but the brush head was not pushed into the patient.The affected endoscope was withdrawn, and the procedure was completed with another endoscope.There was no report of harm to the patient.

• Brand Name: DOUBLE HEADER CHANNEL AND CONTROL HEAD COMBO
• Common Device Name: CLEANING BRUSH
• Manufacturer (Section D): UNITED STATES ENDOSCOPY GROUP, INC.; 5976 heisley rd; mentor, oh
• MDR Report Key: 10489812
• Report Number: 1528319-2020-00028
• Device Sequence Number: 3155409
• Product Code: MNL
• UDI-Device Identifier: 00724995184971
• UDI-Public: (01)00724995184971
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/03/2020

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: 07/13/2023
• Device Model Number: 00711609
• Device Catalogue Number: 00711609
• Device Lot Number: 2006668
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/04/2020
• Initial Report FDA Received Date: 09/03/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1