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

Model Number NM-610U-0325

Device Problem Break (1069)

Patient Problem Injury (2348)

Event Date 07/11/2016

Event Type  Injury  

Manufacturer Narrative

The subject device was returned to olympus medical systems corp.(omsc) for evaluation.The tube sheath was kinked.As the result of checking the manufacturing record of the same lot, there was nothing abnormal detected.Based on the evaluation of the subject device and the similar cases in the past, the retraction failure of the needle tube might be caused by increasing of frictional resistance between the tube sheath and the needle tube.Increasing of frictional resistance might be caused by kinking of the tube sheath.The kinking might be caused by excessive load given to the subject device due to inserting and withdrawing it to an endoscope vigorously.The instruction manual of the subject device warns; *when inserting the instrument into the endoscope, retract the needle into the tube, 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.*insert the instrument slowly.Abrupt insertion could damage the endoscope and/or instrument.*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.

Event Description

During a colorectal polypectomy, the doctor pulled the slider of the subject device and withdrew the subject device from the endoscope.Since the needle tube of the subject device was not retracted into the tube sheath, the needle tube of the subject device stuck to the nurse who operated the subject device.It was reported that the nurse was not given a medical treatment.The doctor completed the procedure with the subject device.

• 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: 5839302
• MDR Text Key: 50908914
• Report Number: 8010047-2016-01010
• Device Sequence Number: 1
• Product Code: FBK
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K153625
• 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: 08/02/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/02/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: NM-610U-0325
• Device Lot Number: 5ZK
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/20/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/11/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/09/2015
• 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