MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. SINGLE USE INJECTOR

Model Number NM-400U-0425

Device Problem Break (1069)

Patient Problem Tissue Damage (2104)

Event Date 11/05/2015

Event Type  Injury  

Manufacturer Narrative

The subject device could not be returned to olympus medical systems corp.(omsc).The exact cause could not be conclusively determined.As the result of checking the manufacturing record of the same lot, there was nothing abnormal detected.This type of event is likely related to the operator's technique.Based on the past similar cases, it is known that the needle could not be retracted into the sheath due to buckling the sheath.It is known that the buckling of the sheath was caused by the excessive stress applied to the sheath while inserting subject device.The instruction manual of the subject device warns; *when inspecting or using the instrument, always wear appropriate personal protective equipment, such as eye wear, a face mask, moisture-resistant clothing and chemical-resistant gloves that fit properly and are long enough so that your skin is not exposed.Otherwise, blood, mucus, and other potentially infectious material from the patient could pose an infection-control risk and/or cause skin irritation.*do not bring the needle in contact with or allow it to pierce nontarget tissue.This may pose an infection control risk, or cause patient or operator injury.*do not coil the insertion portion with a diameter of less than 15 cm.This could damage the insertion portion.*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.*stop using the instrument if the insertion portion bends excessively during use.This could result in malfunction, such as failing to extend the needle or inject a fluid.This report is being submitted as a medical device report in an abundance of caution.

Event Description

It was informed that the doctor injected into the polyp during a colonoscopy.Then the needle of the subject device could not be retracted into the sheath.The doctor withdrew the subject device with the extended needle from the scope.As a result, the needle contacted to the arm of the nurse.The nurse immediately washed and sterilized his/her arm.Also, the nurse visited occupational health.Consequently, no serious injuries have been reported about the nurse to the date.On the other hand, the patient had the blood test to confirm whether there was infectious disease or not.No abnormalities have been reported about the patient to the date.

• Brand Name: SINGLE USE INJECTOR
• Type of Device: INJECTOR
• 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: 5301564
• MDR Text Key: 33587583
• Report Number: 8010047-2015-01281
• Device Sequence Number: 1
• Product Code: FBK
• Combination Product (y/n): N
• Reporter Country Code: EI
• PMA/PMN Number: K914496
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/02/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: NM-400U-0425
• Device Lot Number: 58K
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/02/2015
• Initial Date FDA Received: 12/16/2015
• 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?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other