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

Model Number	711653
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	06/05/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Through follow up, the user facility reported the infinity ercp sampling device subject of the reported event was replaced during the procedure when the brush could not be deployed.A detached component was detected in the pancreatic duct during use of a replacement device.User facility personnel confirmed that the doctor was unsuccessful in retrieving the detached component.The infinity ercp sampling device subject of the reported event was returned for evaluation, which found kinks, bends and a crack in the catheter.These evaluation results are indicative of excess force while using the device.Contrary to the reported event, the fluoroscopic tip was present.Further evaluation of the device found that the radiopaque marker component was not present.On 6/28/2024, steris received medwatch mw5155992 that had been submitted by the user facility.No additional issues have been reported.
Event or Problem Description
The user facility reported that the fluoroscopic tip to their infinity ercp sampling device broke off inside the patient's pancreatic duct.A procedure delay was reported.No report of injury.

• Brand Name: INFINITY ERCP SAMPLING DEVICE
• Common Device Name: 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: 19679760
• Report Number: 1528319-2024-00054
• Device Sequence Number: 20541987
• Product Code: FDX
• UDI-Device Identifier: 00724995184049
• UDI-Public: 00724995184049
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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): 07/05/2024

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: 711653
• Device Catalogue Number: 711653
• Device Lot Number: 6939885
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/05/2024
• Initial Report FDA Received Date: 07/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/28/2023
• 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