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	08/17/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Injection needle failed to deploy.Device appears to be missing a component that connects the needle to the handle.

• Brand Name: SINGLE USE INJECTOR
• Common Device Name: ENDOSCOPIC INJECTION NEEDLE, GASTROENTEROLOGY-UROLOGY
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 800 west park drive; westborough MA 01581
• MDR Report Key: 18502131
• Report Number: 18502131
• Device Sequence Number: 15490440
• Product Code: FBK
• UDI-Device Identifier: 04953170422577
• UDI-Public: (01)04953170422577(17)250331(10)24V
• 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): 09/06/2023
• Report Date (Section F): 09/06/2023

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
• Device Model Number: NM-400U-0425
• Device Catalogue Number: N6139730
• Device Lot Number: 24V
• 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: 01/12/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/12/2024
• 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: Unknown
• Date Report Sent to FDA: 09/06/2023