MAUDE Adverse Event Report: UNITED STATES ENDOSCOPY GROUP, INC. INFINITY ERCP SAMPLING DEVICE; INFINITY SAMPLING DEVICE

Model Number	00711652
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	11/16/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device subject of the reported event was requested back for evaluation however, the device was not available.As the device is not available for evaluation, a root cause of the reported event cannot be determined.The instructions for use packet (ifu 732074) includes the following statements, "prior to use: tighten the luer lock between the white handle and the gray y-port.Hold the proximal device end in one hand, and the distal sheath end in the opposite hand.Rinse the brush with sterile water.Actuate the handle several times to be sure the brush functions properly.If the unit does not function properly, or there is evidence of damage (e.G., bent brush, bent brush stem, kinked catheter), do not use this product and contact your local product specialist.Warnings and precautions: do not force the brush through the endoscope's channel.Reduce angulation of the scope if resistance is met." steris offered in-service training on the proper use and operation of the infinity ercp sampling device however, the user facility declined.No additional issues have been reported.
Event or Problem Description
The user facility reported via medwatch (b)(4) that during a patient procedure, the end of the brush detached from their infinity ercp sampling device.The brush was fully retained and retrieved, and the procedure was completed successfully.No report of injury.

• Brand Name: INFINITY ERCP SAMPLING DEVICE
• Common Device Name: INFINITY SAMPLING DEVICE
• 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: 16613564
• Report Number: 1528319-2023-00006
• Device Sequence Number: 5109791
• Product Code: FDX
• UDI-Device Identifier: 00724995184032
• UDI-Public: 00724995184032
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/24/2023

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: 00711652
• Device Catalogue Number: 00711652
• 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: 02/23/2023
• Initial Report FDA Received Date: 03/24/2023
• 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