MAUDE Adverse Event Report: OLYMPUS CORPORATION OF AMERICAS OLYMPUS INJECTOR FORCE MAX SINGLE USE INJECTOR; ENDOSCOPC INJECTION NEEDLE, GASTROENTEROLOGY-UROLOGY

Model Number NM-4000-0425

Device Problem Failure to Prime (1492)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/20/2019

Event Type  malfunction  

Event Description

Staff unable to prime injector needle with nss.Product was not used on the pt.No harm to the pt.

• Brand Name: OLYMPUS INJECTOR FORCE MAX SINGLE USE INJECTOR
• Type of Device: ENDOSCOPC INJECTION NEEDLE, GASTROENTEROLOGY-UROLOGY
• Manufacturer (Section D): OLYMPUS CORPORATION OF AMERICAS; 3500 corporate pkwy; center valley PA 18034 0610
• MDR Report Key: 8496936
• MDR Text Key: 141574263
• Report Number: MW5085689
• Device Sequence Number: 0
• Product Code: FBK
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 03/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/08/2019
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2020
• Device Model Number: NM-4000-0425
• Device Lot Number: 75K
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 77 YR
• Patient Weight: 97