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

Model Number NM-400U-0523

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/19/2017

Event Type  malfunction  

Manufacturer Narrative

The subject device referenced in this report has not yet been returned to olympus for evaluation.Therefore the exact cause of the reported event could not be conclusively determined at this time.If additional information or the subject device is received at a later time, this report will be supplemented.

Event Description

During a procedure regarding the gastroenterology, the ten nm-400u-0523's were used.It was reported that the needles could be extracted a little bit, but the needles could not be retracted into the sheath for all ten devices.The procedure was canceled.There was no patient injury reported.This report describes the third device.

Manufacturer Narrative

This is a supplemental report for mfr report # 8010047-2017-00857 to provide additional information based on the evaluation result of the subject device.The subject device was returned to olympus medical systems corp.(omsc) for evaluation.As a result of the evaluation on july 31, 2017, it was confirmed that the needle of the subject device had been retracted into the sheath, but it could not be extended.The sheath of the subject device was buckled at 205 mm and 735 mm from the distal end.The device history record for the lot indicated no abnormality with the event-related items.Based on the similar cases in the past, the needle might be unable to retract into the sheath due to the large friction between the sheath and the needle after the sheath was buckled.The sheath might be buckled, because excessive load was applied to the sheath when the subject device was inserted into the endoscope, when it was taken out from the sterile package, or when it was checked before use.The instruction manual of the device has already warned as follows: 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.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: 6700066
• MDR Text Key: 80052242
• Report Number: 8010047-2017-00857
• 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: company representative,foreig
• Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date: 08/25/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/11/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: NM-400U-0523
• Device Lot Number: K6Y16
• Other Device ID Number: 04953170382291
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/28/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/31/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/16/2016
• 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