MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORPORATION SINGLE USE INJECTOR; INJECTION NEEDLE

Model Number NM-400U-0425

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/09/2014

Event Type  malfunction  

Event Description

It was tested and confirmed that the needles of the subject device worked correctly before this device was inserted into the endoscope.But the needle failed to come out when this device was inserted into the endoscope.After this device was withdrawn from the endoscope and tested, the needle failed to come out again.This happened on two occasions with the same lot.

Manufacturer Narrative

Olympus could not investigate them because the user disposed of the subject devices.Since the manufacture record of the subject devices were unknown, the manufacture record that dated back the past one year from the delivery date to the user was reviewed without apparent irregularity associated with the subject phenomenon.Judging from the past similar cases, there are possibilities that the cause of this phenomenon is kinked tube.It is considered that upon inserting this subject device into a scope, the tube was bent and kinked.This report is being submitted as a medical device report in an abundance of caution.

• Brand Name: SINGLE USE INJECTOR
• Type of Device: INJECTION NEEDLE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORPORATION; 2951 ishikawa-cho; hachioji-shi, tokyo 192- 8507; JA 192-8507
• Manufacturer Contact: hiroki moriyama ; 2951 ishikawa-cho; hachioji-shi, tokyo 192-8-507 ; JA 192-8507 ; 26425177
• MDR Report Key: 4381351
• MDR Text Key: 5124643
• Report Number: 8010047-2014-01150
• Device Sequence Number: 1
• Product Code: FBK
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 12/11/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/25/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: NM-400U-0425
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/16/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: NM-400U-0425 (MDR MFR REPORT# 8010047-2014-01159)