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

Model Number NM-401L-0425

Device Problems Failure to Deliver (2338); Defective Device (2588)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/03/2021

Event Type  malfunction  

Manufacturer Narrative

The subject device was received and evaluated.The device return evaluation results as follows: ·the lot no.Was 11v18.·a deep kink on the tube sheath just right below the handle boot.·the slider is functioning properly as it could extend and retract the needle without an issue.·the inner needle tubing of the used device appeared to be buckled inside the handle which has contributed to the reported complaint.·when using a test syringe to inject water into the injection port, it was verified that water was able to expel out when the needle was either inside or outside the tube sheath without a problem.Based on legal manufacturer's investigations results , the device history record for the lot indicated no abnormalities.The record review includes the following.-process inspection sheet -quality inspection sheet -nonconforming product report the instruction manual contains the following descriptions, and it warns against this event.(rk2423 rev.01) ·straighten out the instrument before inspecting it.The instrument can be damaged if it is coiled while the handle is operated.·operate the slider slowly, otherwise the tube could buckle.·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.Conclusion summary the reported phenomenon could not be replicated.Therefore, the exact cause of the reported event could not be determined.However, from evaluation results, it can be inferred that kink of the tube causing the reported event.A bending force might have been applied to the tube when the device was inserted into the endoscope, removed from the sterile package or during pre-inspection.This might have caused the tube to buckle.The needles undergo 100% appearance inspection and function inspection during production process.Therefore, aomori olympus presume the phenomenon was due to the handling at the facility.Although the root cause of this event could not be determined, we will continue to monitor trends and take appropriate actions as necessary.Olympus will continue to monitor complaints for this device.

Event Description

As reported, the nm-401l-0425 solution was prepared, injected and needle was primed, when the needle is inserted in scope channel and needle was locked, the needle would not inject.A separate needle from same lot number worked properly.The issue found during an unknown event.There was no patient harm or injury reported due to the event.No user injury reported.

• 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 192-8 507; JA 192-8507
• Manufacturer Contact: kazutaka matsumoto ; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8-507 ; JA 192-8507 ; 426425177
• MDR Report Key: 12905072
• MDR Text Key: 285940546
• Report Number: 8010047-2021-15292
• Device Sequence Number: 1
• Product Code: FBK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K902736
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/30/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: NM-401L-0425
• Device Lot Number: 11V 18
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/22/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/04/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/17/2021
• 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
• Treatment: SCOPE