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

Model Number NM-400U-0423

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/24/2014

Event Type  malfunction  

Event Description

Olympus medical systems corp (omsc) was informed that during unspecified procedure the 3 needles could not project out from the sheath.There was no report of pt injury regarding this event.

Manufacturer Narrative

The subject products were not returned for eval.The exact cause of the user's report could not be conclusively determined.Our company rep informed that they confirmed the subject 3 needles.The first needle could not project out from the sheath and the insertion portion was deformed.The second one could be extended by the slider operation was sightly heavy.The third one could be operated normally.As the checking of the mfg record of the same lot, nothing abnormal detected.Therefore, omsc thinks that the deformation of the insertion portion due to handling or the complicated shape of the endoscope insertion may cause this event.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
• MDR Report Key: 4264459
• MDR Text Key: 5297219
• Report Number: 8010047-2014-00634
• 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,Company Representative
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 09/24/2014

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 Operator: Other
• Device Model Number: NM-400U-0423
• Device Lot Number: K4725
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/24/2014
• Initial Date FDA Received: 10/20/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: (B)(4) (MDR# 8010047-2014-00592/00593)