MAUDE Adverse Event Report: AOMORI OLYMPUS CO., LTD. SINGLE USE INJECTOR NM600/610; INJECTOR AND SHEATHSET

Model Number NM-610U-0423

Device Problem Off-Label Use (1494)

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

Event Date 12/05/2022

Event Type  malfunction  

Event Description

It was reported to olympus that the single use injector nm-610u-0423 was expired when it was sold via a third party company (endocorp).There were no reports of patient harm associated with the event.

Manufacturer Narrative

The investigation is ongoing and follow up with the user facility is currently being performed.A supplemental report will be submitted upon completion of the investigation or if any additional information is provided by the user facility.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.A review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been over 7 years since the subject device was manufactured.The device was not returned for evaluation.Based on the results of the investigation, it¿s likely the event occurred due to the third party company¿s handling.The root cause of this event was unable to be identified.The following is included in the instructions for use: ¿this instruction manual contains essential information on using this instrument safely and effectively.Before use, thoroughly review this manual and the manuals for all equipment that will be used during the procedure and use the instruments as instructed.If you have any questions or comments about any information in this manual, contact olympus.Do not use an instrument after the expiration date displayed on the sterile package.Doing so may pose an infection control risk or cause tissue irritation.¿ olympus will continue to monitor field performance for this device.

• Brand Name: SINGLE USE INJECTOR NM600/610
• Type of Device: INJECTOR AND SHEATHSET
• Manufacturer (Section D): AOMORI OLYMPUS CO., LTD.; 2-248-1 okkonoki; kuroishi-shi, aomori 036-0 357; JA 036-0357
• Manufacturer (Section G): AOMORI OLYMPUS CO., LTD.; 2-248-1 okkonoki; kuroishi-shi, aomori
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 16094206
• MDR Text Key: 308722329
• Report Number: 9614641-2023-00009
• Device Sequence Number: 1
• Product Code: FBK
• UDI-Device Identifier: 04953170377952
• UDI-Public: 04953170377952
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K153625
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 01/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/04/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: NM-610U-0423
• Device Lot Number: 5ZK
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/05/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/14/2015
• 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