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

Model Number	00711144
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Separation Problem (4043)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/16/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The distributor reported that during a patient procedure, the capsule cup remained attached to the pill camera when the pill camera was deployed.A roth net retrieval device was used to retrieve the device.No report of procedure delay.
Additional Manufacturer Narrative
The event is investigation in process as the advance capsule endoscope delivery device subject of the reported event will be returned to steris for evaluation.A follow-up report will be submitted once additional information becomes available.Udi related data clarification: the lot/serial number are unknown; therefore, the applicable udi and production identifiers were not included in this report.
Additional Manufacturer Narrative
No additional medical intervention or treatment was needed due to the reported issue.Steris requested the return of the device subject of the reported event; however, the device was not returned for evaluation.Without, the return of the device the exact cause of the reported event could not be determined.Steris offered in-service training to the proper use and operation of the device and the user facility declined.No additional issues have been reported.

• 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: 21953614
• Report Number: 1528319-2025-00038
• Device Sequence Number: 12898518
• Product Code: NEZ
• UDI-Device Identifier: 00724995183608
• UDI-Public: (01)00724995183608
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/02/2025

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
• 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: 04/17/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/02/2025
• Supplement Report FDA Received Date: 10/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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