MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. OLYMPUS INJECTOR FORCE MAX SINGLE USE INJECTOR; ENDOSCOPIC INJECTION, NEEDLE

Model Number NM-400U-0525

Device Problems Failure to Prime (1492); Failure to Deliver (2338)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/25/2019

Event Type  No Answer Provided  

Event Description

Equipment malfunction.Needle would not prime and medication could not be injected.

• Brand Name: OLYMPUS INJECTOR FORCE MAX SINGLE USE INJECTOR
• Type of Device: ENDOSCOPIC INJECTION, NEEDLE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.
• MDR Report Key: 8600507
• MDR Text Key: 144942708
• Report Number: MW5086545
• Device Sequence Number: 1
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/09/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2021
• Device Model Number: NM-400U-0525
• Device Lot Number: 8ZK
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 60 YR
• Patient Weight: 92