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

Model Number	00711652
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/18/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 device subject of this complaint has not been returned to steris endoscopy for evaluation.Statements from the instructions for use include: "do not force the brush through the endoscope's channel.Reduce angulation of the scope if resistance is met.Prior to procedure, 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.When using a guidewire, irrigate the guidewire lumen of the catheter with sterile water/saline." the distributor has offered in-service training to the user facility on behalf of steris endoscopy; however, the user facility has declined.
Event or Problem Description
The distributor reported that the brush head component of an infinity ercp sampling device detached during a patient procedure for sampling a tumor in the bile duct.The brush head was retrieved, and the procedure was completed.No harm to the patient or user was reported.

• Brand Name: INFINITY ERCP SAMPLING DEVICE
• Common Device Name: SAMPLING DEVICE
• Manufacturer (Section D): UNITED STATES ENDOSCOPY GROUP, INC.; 5976 heisley rd; mentor OH 44060
• MDR Report Key: 10588753
• Report Number: 1528319-2020-00033
• Device Sequence Number: 2670428
• Product Code: FDX
• UDI-Device Identifier: 00724995184032
• UDI-Public: (01)00724995184032
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K151889
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/25/2020

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: 06/15/2023
• Device Model Number: 00711652
• Device Catalogue Number: 00711652
• Device Lot Number: 2005658
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/26/2020
• Initial Report FDA Received Date: 09/25/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1