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

Model Number NM-400U-0425

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/11/2017

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 mucosectomy, the subject device was used.During the procedure, the needle of the subject device was difficult to be removed and the physician could not perform the injection.The physician tried to retract the needle, but the needle could not be retracted into the sheath.The procedure was completed with a spare device of the same model.There was no patient injury reported.

Manufacturer Narrative

This is a supplemental report for mfr report # 8010047-2017-00681 to provide additional information.The subject device has not been returned to olympus medical system corp.(omsc) for evaluation.The exact cause of the reported phenomenon could not be conclusively determined.The device history record for the lot indicated no abnormality with the event-related items below.1)needle extension/retraction 2)extended length of the needle 3)no bent, kink, crack and scratch on the tube.4)injection of the liquid based on the similar cases in the past, the needle might be unable to retract into the sheath due to the compressive buckling on the needle tube.The compressive buckling on the needle tube was likely caused by the large friction between the sheath and the needle tube when the needle was extended.It was likely that the friction between the outer tube and the needle increased by the following factors.1) the needle was extended/retracted while the tube was bent at inspection of operation.2) the slider was abruptly pushed.3) the buckling of the tube.The instruction manual of the device has already warned as follows; 1)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.2)insert the instrument slowly.Abrupt insertion could damage the endoscope and/or instrument.3)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: 6613549
• MDR Text Key: 76737182
• Report Number: 8010047-2017-00681
• 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: Health Professional
• Type of Report: Initial,Followup
• Report Date: 07/15/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/05/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: NM-400U-0425
• Device Lot Number: 71K
• Other Device ID Number: 04953170382284
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/23/2017
• 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