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

Model Number NM-400U-0425

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

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

Event Date 11/29/2021

Event Type  malfunction  

Event Description

As reported, customer reported an out of box failure (oob).Customer reported that both needles with model (nm-400u-0425) failed to inject during a colonoscopy procedure.There was no patient harm or injury reported due to the event.No user injury reported.This report is related to a report with patient identifier (b)(4).

Manufacturer Narrative

The subject device has not yet been returned for evaluation/investigation.Therefore, the root cause of the reported phenomenon could not be determined at this time.Investigation is ongoing.This report will be supplemented accordingly following investigation.

Event Description

Device was inspected prior to use and did not have any issues.Customer believes the same device was used to complete the procedure and confirmed no delay or patient impact.The needle fluid was either ink or saline.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation and customer follow-up.B5 - updated with information received from the customer.H4 - the manufacturing month/year of lot 09va is september, 2020.A review of the device history record found no deviations that could have caused or contributed to the reported issue.Based on the investigation results, the specific root cause of the needles failing to inject could not be determined at this time as the device was not returned for evaluation.Replication testing was completed and unable to replicate the issue.The following information is stated in the instructions for use: -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.Olympus will continue to monitor field performance for this device.

• 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: 13234242
• MDR Text Key: 293269122
• Report Number: 8010047-2022-01291
• Device Sequence Number: 1
• Product Code: FBK
• UDI-Device Identifier: 04953170382284
• UDI-Public: 04953170382284
• 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,Followup
• Report Date: 04/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/12/2022
• 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: 09VA
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/15/2022
• 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