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

Model Number	NM-401L-0523
Medical Device Problem Code	Failure to Infuse (2340)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The subject device referenced in this report was not returned to olympus for evaluation.Therefore the exact cause of the reported event could not be conclusively determined at this time.A supplemental report will be submitted, if additional or significant information becomes available at a later time.
Event or Problem Description
We received the following report.The test with the needle prior to use was flawless.Then after the needle was extended, it was not possible to inject.There was no patient injury reported.This is the report regarding the failure of the injection.
Additional Manufacturer Narrative
This is a supplemental report to provide additional information.Two devices were returned to olympus medical systems corp.(omsc) for evaluation.This is the first one of two reports.When we push the slider, we could not inject a liquid.However, we pulled the slider, we could inject a liquid.The tube had no kink and no deformation.The needle tube of the device had compressive buckling.There was a foreign substance on the tube.The manufacturing record was reviewed and found no irregularities.Aomori olympus concluded that the phenomenon occurred due to the compressive bucking on the needle tube.The compressive buckling on the needle tube was likely caused when the needle was extended because of the great friction between the outer tube and the needle.It was likely that the friction between the outer tube and the needle increased by the following factors.The needle extended/retracted while the tube was coiled in inspection of operation.The slider was abruptly pushed.The above device handling has warned in the instruction manual.

• Brand Name: SINGLE USE INJECTOR
• Common Device Name: INJECTOR AND SHEATHSET
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• MDR Report Key: 10031242
• Report Number: 8010047-2020-02497
• Device Sequence Number: 11686655
• Product Code: FBK
• UDI-Device Identifier: 04953170260032
• UDI-Public: 04953170260032
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K902736
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/04/2020

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: No Information
• Device Model Number: NM-401L-0523
• Device Lot Number: K9820
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/03/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 04/17/2020
• Supplement Date Received by Manufacturer: 09/03/2020
• Initial Report FDA Received Date: 05/06/2020
• Supplement Report FDA Received Date: 12/04/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1