MAUDE Adverse Event Report: US ENDOSCOPY; BIOPSY NEEDLE

Model Number	00711812
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/25/2025
Type of Reportable Event	Malfunction
Event or Problem Description
From staff: steris needle was leaking at the connector while in use for procedure.Patient came in for endoscopy procedure, during procedure a steris needle was deployed for use with a lifting agent.Once deployed the needle was found to be leaking at the connection site.Needle was sequestered and new needle was deployed, procedure was completed without incident.

• Brand Name: NA
• Common Device Name: BIOPSY NEEDLE
• Manufacturer (Section D): US ENDOSCOPY; 5976 heisley rd; mentor OH 44060
• MDR Report Key: 22519225
• Report Number: 22519225
• Device Sequence Number: 9231899
• Product Code: FCG
• UDI-Device Identifier: 00724995180898
• UDI-Public: (01)00724995180898
• Combination Product (Y/N): N
• Initial Reporter State: ME
• 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): 06/26/2025
• Report Date (Section F): 06/26/2025

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: 00711812
• Device Catalogue Number: 00711812
• Device Lot Number: (01)12339956
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Device Age: 3 MO
• Event Location: Hospital
• Date Report to Manufacturer: 07/16/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/16/2025
• 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: 73 YR
• Patient Sex: Male
• Patient Weight: 144 KG
• Date Report Sent to FDA: 06/26/2025