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

Model Number NM-400U-0323

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/20/2017

Event Type  malfunction  

Manufacturer Narrative

The subject device in this report has not yet been returned to olympus medical systems corp.(omsc) for evaluation.This will be supplemented if additional information or device evaluation becomes available at a later time.

Event Description

During a gastroenterology, the subject device was used.In the procedure, the needle of the subject device could not be retracted into the sheath.The procedure was completed with another device.There was no patient injury reported.

Manufacturer Narrative

The subject device was not returned to olympus medical system corp.(omsc).Therefore, omsc could not evaluate the reported device.The exact cause of this issue could not be conclusively determined.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; 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
• 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: 7112182
• MDR Text Key: 95731462
• Report Number: 8010047-2017-01978
• Device Sequence Number: 1
• Product Code: FBK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK902736
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date: 01/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/13/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: NM-400U-0323
• Device Lot Number: 73K
• Other Device ID Number: 04953170382260
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/14/2017
• 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