MAUDE Adverse Event Report: UNITED STATES ENDOSCOPY GROUP, INC. GEMINI DOUBLE ENDED CHANNEL

Model Number	00711607
Medical Device Problem Code	Suction Problem (2170)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/08/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The user facility did not disclose the lot number of the brush subject of the reported event.The device subject of the reported event will not be returned for evaluation.The instructions for use packet (ifu 731015) gives the following instructions using the cleaning brush."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.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.Do not use a specific cleaning brush in a specific channel if use is not recommended by the endoscope's original equipment manufacturer.Channel cleaning brush: using the cleaning media of choice, advance the cleaning brush through the entire length of the endoscope before reversing direction.Reversing direction inside the endoscope could cause the brush to expand, which could potentially damage the endoscope.Using the cleaning media of choice, pass the channel cleaning brush through the valve stem openings.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." steris offered in-service training on the proper use and operation of the gemini double ended channel however, the user facility has declined.No additional issues have been reported.
Event or Problem Description
The user facility reported via medwatch report (b)(4) that during a procedure user facility personnel found a cleaning brush component from prior reprocessing had been retained in the endoscope.No report of harm to the patient.

• Brand Name: GEMINI DOUBLE ENDED CHANNEL
• Common Device Name: GEMINI DOUBLE ENDED CHANNEL
• Manufacturer (Section D): UNITED STATES ENDOSCOPY GROUP, INC.; 5976 heisley road; mentor OH 44060
• Manufacturer (Section G): UNITED STATES ENDOSCOPY GROUP, INC.; 5976 heisley road; mentor OH 44060
• Manufacturer Contact: coletta cohara ; 5976 heisley road; mentor, OH 44060 ; 4403586251
• MDR Report Key: 16293152
• Report Number: 1528319-2023-00004
• Device Sequence Number: 17843315
• Product Code: MNL
• UDI-Device Identifier: 00724995184964
• UDI-Public: 00724995184964
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/03/2023

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 Model Number: 00711607
• Device Catalogue Number: 00711607
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/04/2023
• Initial Report FDA Received Date: 02/03/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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 Sex: Unknown