MAUDE Adverse Event Report: US ENDOSCOPY ADVANCE; SYSTEM, IMAGING, GASTROINTESTINAL, WIRELESS, CAPSULE

Model Number	00711144
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/17/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Device assembled through egd scope to deliver pillcam into the duodenum under anesthesia.When attempting to deploy the pillcam, the heavy wire which was meant to push the capsule out of the holder instead pushed between two of the plastic fingers holding the capsule to the end of the egd scope.

• Brand Name: ADVANCE
• Common Device Name: SYSTEM, IMAGING, GASTROINTESTINAL, WIRELESS, CAPSULE
• Manufacturer (Section D): US ENDOSCOPY; 5976 heisley rd; mentor OH 44060
• MDR Report Key: 20266558
• Report Number: 20266558
• Device Sequence Number: 3531226
• Product Code: NEZ
• UDI-Device Identifier: 00724995183608
• UDI-Public: (01)00724995183608
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/14/2024
• Report Date (Section F): 06/14/2024

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: 8482771
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 09/20/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/20/2024
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Age: 81 YR
• Patient Sex: Male
• Patient Weight: 64 KG
• Date Report Sent to FDA: 06/14/2024