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

Model Number	00711144
Medical Device Problem Code	Failure to Fire (2610)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/24/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The advance capsule endoscope delivery devices subject of the reported event are being returned for evaluation.The lot numbers are (10)12143995, (10)12009838, (10)12678065, (10)12588992.Investigation of the event is currently in progress.A follow-up report will be submitted when additional information becomes available.Udi related data clarification - the lot number(s) exceeded the text limit for field d4, therefore, the serial number(s) are included in field h11.
Event or Problem Description
The user facility reported that during patient procedures, the handle to their advance capsule endoscope delivery device broke causing the device to misfire the capsule.The procedures were completed successfully following a delay.No report of injuries.
Additional Manufacturer Narrative
Three of the four advance capsule endoscope delivery devices subject of the reported event were returned for evaluation.The first device (lot 12009838) found that the distal end was slightly bent which could indicate excess force being used.The deployment assembly and capsule cup were returned and found the device was able to deploy with no issue.The second device (lot 12588992) found that the distal end had a slightly bent which could indicate excess force being used.The original capsule cup was not returned.The deployment assembly was tested using a spare capsule cup and no issues were noted.Upon review of the third device (lot 12678065), it was found that the insert mold tip was detached from the handle assembly, and the capsule was not returned.The molded tip had deformation, which can indicate that the tip was at one point attached to the handle assembly.Additionally, it was observed that the hypo tube in the handle assembly was bent, which could indicate excess force being used, and there was a bend under the handle, which could indicate the device was used at an angle.Further review of the device found that the mold tip was able to be inserted back into the handle assembly and stay inserted.The device was tested and deployed without issue.The cable did not deploy to the side.The reported issue of failing to deploy could not be replicated.The device cable deploying to the side could not be duplicated.The handle assembly breaking was confirmed; however, the cause of the detachment could not be determined.An empty pouch for (lot 12143995) was returned.Without the return of the device an evaluation could not be performed, and a cause of the event could not be determined.The device history records were reviewed for all subject lots and confirmed they were manufactured to specifications; no abnormalities were noted.A complaint review was performed and confirmed the event to be isolated for all four lots.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 ; 4403586251
• MDR Report Key: 23381391
• Report Number: 1528319-2025-00101
• Device Sequence Number: 13023313
• Product Code: NEZ
• UDI-Device Identifier: 00724995183608
• UDI-Public: (01)00724995183608(11)250402(17)280402(10)12143995
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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,Followup
• Report Date (Section B): 10/24/2025

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: 00711144
• Device Catalogue Number: 00711144
• 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: 09/26/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/24/2025
• Supplement Report FDA Received Date: 01/07/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/26/2025
• 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