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

Model Number NM-610U-0325

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/19/2016

Event Type  malfunction  

Manufacturer Narrative

Since the subject device was discarded, it was not returned to olympus medical systems corp.(omsc) for evaluation.The lot no.Was unknown.Therefore, as the result of checking the manufacturing record of three months in the past from (b)(6) 2016 (delivery date), there was nothing abnormal detected.The exact cause could not be conclusively determined.However, based on the similar cases in the past, it is known that the needle could not be retracted into the sheath due to buckling the sheath.The buckling of the sheath might be caused by the excessive stress applied to the sheath while inserting forcibly the subject device into the endoscope or manipulating excessive angulation of the endoscope.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.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.Do not force the instrument if resistance to insertion is encountered.Reduce the angulation of the endoscope until the instrument passes smoothly.Attempting to force the instrument could cause patient injury, such as perforation, bleeding, or mucous membrane damage.It could also damage the endoscope and/or instrument.

Event Description

During an endoscopic submucosal dissection, the needle tube of the subject device could not be retracted after pulling and pushing the slider of the subject device a few times.The doctor completed the procedure with another device.No patient injury was reported.

• 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: 5944980
• MDR Text Key: 54506886
• Report Number: 8010047-2016-01177
• 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: Other
• Type of Report: Initial
• Report Date: 09/13/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/12/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: NM-610U-0325
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/23/2016
• 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