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	03/18/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Njectorforce max/olympus single use injector failed to advance needle out of the device when assistant attempted to activate the mechanism to "needle out".New injector opened, tested the function on this new device prior to inserting into gastroscope- device working correctly/needle was advancing properly when mechanism initiated.Device inserted into scope, device catheter in view on screen, device failed to work again.Resistance met when trying to advance the needle into view.Third injector opened, tested mechanism- confirmed it was working correctly, inserted into scope and this time needle device advancing properly and injection was able to be performed.

• 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: 17563468
• Report Number: 17563468
• Device Sequence Number: 15139030
• Product Code: FBK
• UDI-Device Identifier: 04953170422577
• UDI-Public: (01)04953170422577
• 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): 05/16/2023
• Report Date (Section F): 05/16/2023

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
• Operator of Device: Health Professional
• Device Model Number: NM-400U-0425
• Device Lot Number: STERILE LOT 22V3064 LOT 29V
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 08/17/2023
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/17/2023
• 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: 89 KG
• Patient Race: White
• Date Report Sent to FDA: 05/16/2023