MAUDE Adverse Event Report: US ENDOSCOPY ADVANCE; ADVANCE CAPSULE ENDOSCOPE DELIVERY DEVICE

Model Number	00711144
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/29/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Following the reported event, user facility personnel returned the device.Upon evaluation of the returned device, it was found that only the delivery assembly was returned.The capsule cup was not returned.When evaluating the delivery assembly, the distal end was bent which could indicate that the device was being used when it was articulated.The advance capsule endoscope delivery device instructions for use states, "straighten the handle and catheter and repeat deployment step." a capsule cup was utilized with the returned delivery assembly during testing and the device deployed/operated as expected; no issues were noted with the function or operation.The reported event could not be duplicated.The device history record was reviewed for the subject lot and no abnormalities were noted.A complaint review was performed and confirmed the event to be isolated for the subject lot.No additional issues have been reported.
Event or Problem Description
The user facility reported via medwatch (b)(4) that during a patient procedure, their advance capsule endoscope delivery device did not deploy.Another device was utilized, and the patient procedure was completed successfully.No report of injury.

• Brand Name: ADVANCE
• Common Device Name: ADVANCE CAPSULE ENDOSCOPE DELIVERY DEVICE
• Manufacturer (Section D): US ENDOSCOPY; 5976 heisley road; mentor 44060
• Manufacturer (Section G): US ENDOSCOPY; 5976 heisley road; mentor OH 44060
• Manufacturer Contact: coletta cohara ; 5976 heisley road; mentor 44060 ; 4404130648
• MDR Report Key: 21172820
• Report Number: 1528319-2025-00003
• Device Sequence Number: 17294132
• Product Code: NEZ
• UDI-Device Identifier: 00724995183608
• UDI-Public: (01)00724995183608(11)240613(17)270613(10)10578820
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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): 01/16/2025

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 Model Number: 00711144
• Device Catalogue Number: 00711144
• Device Lot Number: (10)10578820
• 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: 12/17/2024
• Initial Report FDA Received Date: 01/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/13/2024
• 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