MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. SINGLE USE INJECTOR NM600/610; INJECTOR AND SHEATHSET

Model Number NM-610L-0423

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

Patient Problem Injury (2348)

Event Date 02/20/2017

Event Type  Injury  

Manufacturer Narrative

The subject device was not returned to olympus medical systems corp.(omsc) for evaluation, because the subject device was already discarded.The lot no.Was unknown.Therefore, as the result of checking the manufacturing record of the devices which had delivered to the customer during past one year, there was nothing abnormal found.The exact cause could not be conclusively determined.However, based on the similar cases in the past, the needle tube might remain extended from the sheath of the subject device, because the sheath was kinked.The sheath might be kinked, because excessive load was applied to the sheath when the subject device was inserted into the endoscope, it was taken out from the sterile package, or it was checked before use.The instruction manual of the subject device warns; *when inserting the instrument into the endoscope, retract the needle into the sheath, hold the instrument close to the biopsy valve, and keep it as straight as possible relative to the biopsy valve.Otherwise, the instrument could be damaged.*before use, inspect the insertion portion and the tube for damage.

Event Description

During an endoscopic submucosal dissection, the subject device was used.The user temporarily withdrew the subject device from the endoscope.After that, the doctor tried to insert the subject device into the endoscope again.At the time, the needle tube of the subject device was stuck to the nurse because the needle tube was extended from the sheath of the subject device.The intended procedure was completed with another device.The nurse had the blood test to confirm whether there was infectious disease or not.No abnormalities have been reported about the nurse.The nurse already recovered.

• Brand Name: SINGLE USE INJECTOR NM600/610
• Type of Device: INJECTOR AND SHEATHSET
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• Manufacturer Contact: hiroki moriyama ; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8-507 ; JA 192-8507 ; 8142642517
• MDR Report Key: 6412190
• MDR Text Key: 70171091
• Report Number: 8010047-2017-00301
• Device Sequence Number: 1
• Product Code: FBK
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Nurse
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/16/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: NM-610L-0423
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/22/2017
• 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
• Patient Outcome(s): Other