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

Model Number NM-610U-0423

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/22/2017

Event Type  malfunction  

Manufacturer Narrative

The subject device in this report has not yet been returned to olympus medical systems corp.(omsc) for evaluation.The exact cause of the reported event could not be conclusively determined at this time.If additional information becomes available or if the device is returned at a later time, this report will be supplemented.

Event Description

During an uncertain procedure, the needle of the subject device could not be moved and retracted into the tube.There was no patient injury reported.

Manufacturer Narrative

This is a supplemental report to provide additional information based on the evaluation of the device.The subject device was returned to olympus medical systems corp.(omsc).Omsc investigated it on november 2, 2017.The needle of the subject device could not be retracted into the outer tube.The outer tube of the subject device was kinked at approximately 270 mm, 870 mm, 1030 mm, and 1420 mm from the distal end.The manufacturing record was reviewed and found no irregularities.The reported event is most likely related to the operator's technique.Omsc surmised that the kinks of the outer tube occurred due to applying bending load to the outer tube when the tube was inserted into the endoscope, the subject device was unpacked from the sterile bag, or pre-use inspection was performed.The frictional resistance between the outer tube and the needle tube increased due to the kinks, and then the needle could not be retracted into the outer tube.The instruction manual of the device has already warned as follows; warnings: 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.

• 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
• Manufacturer Contact: katsuaki morita ; 2951 ishikawa-cho; hachioji-shi, tokyo-to ; 426425177
• MDR Report Key: 6954055
• MDR Text Key: 90572534
• Report Number: 8010047-2017-01485
• Device Sequence Number: 1
• Product Code: FBK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK153625
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/23/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/17/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: NM-610U-0423
• Device Lot Number: 74K
• Other Device ID Number: 04953170377952
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/01/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/02/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/07/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1