MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. SINGLE USE INJECTOR; ENDOSCOPIC INJECTION NEEDLE, GASTROENTEROLOGY-UROLOGY

Model Number	NM-400U-0425
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/28/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Inserted injector needle down scope, tried to deploy needle from sheath to inject, but needle would not come out.Removed injector needle from scope, attempted to deploy needle outside of scope, and needle would not deploy either.

• Brand Name: SINGLE USE INJECTOR
• Common Device Name: ENDOSCOPIC INJECTION NEEDLE, GASTROENTEROLOGY-UROLOGY
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.
• MDR Report Key: 20771114
• Report Number: 20771114
• Device Sequence Number: 14528309
• Product Code: FBK
• UDI-Device Identifier: 04953170422577
• UDI-Public: (01)04953170422577(17)261231(10)41V
• 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): 11/19/2024
• Report Date (Section F): 11/19/2024

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: Other
• Device Model Number: NM-400U-0425
• Device Catalogue Number: N6139730
• Device Lot Number: 41V
• 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: 11/25/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/25/2024
• 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 Sex: Male
• Patient Weight: 52 KG
• Date Report Sent to FDA: 11/19/2024