MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. DISPOSABLE INJECTOR NM

Model Number NM-200U-0423

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/27/2015

Event Type  malfunction  

Manufacturer Narrative

The subject device was returned to olympus medical systems corp.(omsc) for investigation.The investigation confirmed that the needle of the subject device couldn't be retracted into the sheath.On the handle side, the tube came off the metal pipe.The dimensions of the tube and the metal pipe satisfied product standards.As the result of checking the manufacturing record of the same lot, there was nothing abnormal detected.Based on the investigation of the subject device, omsc concluded that the needle couldn't be retracted into the sheath, because the tube came off the metal pipe on the handle side.However the cause that the tube came off the metal pipe couldn't be conclusively determined at this time.Also, based on the past similar cases, there is a possibility that the tube came off the metal pipe on the handle side, because the frictional resistance between the tube and the sheath became greater due to operating the subject device with tight angulation.It was known that the needle might be damaged due to a doctor's handling of a scope.The instruction manual of the subject device warns; do not force the instrument if resistance to insertion is encountered.Reduce the angulation or lower the forceps elevator of the endoscope until the instrument passes smoothly.Attempting to force the instrument could cause patient injury, such as punctures, hemorrhages or mucous membrane damage.It could also damage the endoscope and/or instrument.This report is being submitted as a medical device report in an abundance of caution.

Event Description

It was informed that during a colorectal polypectomy, the needle of the subject device couldn't be retracted into the sheath after the doctor pierced the tissue once.The doctor replaced the device, and completed the procedure with another device.There was no patient injury regarding this report.

• Brand Name: DISPOSABLE INJECTOR NM
• Type of Device: INJECTOR NM
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951; ishikawa-cho; hachioji-shi, tokyo 192-8 507; JA 192-8507
• Manufacturer Contact: susumu nishina ; 2951; ishikawa-cho; hachioji-shi, tokyo 192-8-507 ; JA 192-8507 ; 426425177
• MDR Report Key: 5225242
• MDR Text Key: 31276014
• Report Number: 8010047-2015-01081
• Device Sequence Number: 1
• Product Code: FBK
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K914496
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/27/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/16/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: NM-200U-0423
• Device Lot Number: 57K
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/30/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/27/2015
• Was Device Evaluated by Manufacturer?: Yes
• 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