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

Model Number	NM-610U-0426
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/03/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is not returned, as such a definitive root cause of the reported complaint cannot be determined at this time.This event is under investigation.A supplemental report will be submitted upon completion of the investigation or upon receiving additional information.
Event or Problem Description
As reported for this event by the customer, during an unknown procedure the customer had difficulty in opening the sealed package of the device.This device is sealed with an additional seal package.Since the customer had to forcibly open the package, there is a chance of contamination by contact with an unclean area.Customer is recommending that the package seal be improved for ease of opening.
Additional Manufacturer Narrative
Additional information has been received for this event.This supplemental report is being submitted to provide this information.Please see the updates in sections: b5, g3, g6, h2, and h10.Patient information is not known.
Event or Problem Description
Though the customer complained about the difficulty in opening the device package seal, the customer was able to open the packaging and use the device in the procedure.There was no harm or adverse impact on the patient.The procedure details are not known.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.H4: the subject device was manufactured in may 2022.A review of the device history record found no deviations that could have caused or contributed to the reported issue.The legal manufacturer's final investigation confirmed that the sterile packages that are additionally heat-sealed have a higher seal strength than those that are not additionally heat-sealed.Therefore, the sterile packages with additional heat sealing are difficult to open.The legal manufacturer has determined there is no potential for this malfunction to cause or contribute to an adverse event.

• Brand Name: SINGLE USE INJECTOR NM600/610
• Common Device Name: INJECTOR AND SHEATHSET
• Manufacturer (Section D): AOMORI OLYMPUS CO., LTD.; 2-248-1 okkonoki; kuroishi-shi, aomori 036-0 357; JA 036-0357
• Manufacturer Contact: masaharu hirose ; 2-248-1 okkonoki; kuroishi-shi, aomori 036-0-357 ; JA 036-0357 ; 426422891
• MDR Report Key: 15322163
• Report Number: 9614641-2022-00230
• Device Sequence Number: 12062902
• Product Code: FBK
• UDI-Device Identifier: 04953170422874
• UDI-Public: 04953170422874
• Combination Product (Y/N): N
• Initial Reporter Country: TH
• PMA/510(K) Number: K153625
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: NM-610U-0426
• Device Lot Number: 25K
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/03/2022
• Supplement Date Received by Manufacturer: 09/06/2022; 10/03/2022
• Initial Report FDA Received Date: 08/30/2022
• Supplement Report FDA Received Date: 09/20/2022; 10/19/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown