MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. DISPOSABLE INJECTOR NM; INJECTOR AND SHEATHSET

Model Number	NM-200U-0423
Medical Device Problem Code	Failure to Infuse (2340)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/07/2020
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.When the user prepared to do a submucosal injection, the user found that the subject device became clogged and was unable to use properly.The user exchanged the subject device for another device.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.The subject device was not returned to olympus medical systems corp.(omsc) for evaluation.Therefore, the exact cause of the reported event could not be conclusively determined.The manufacturing record was reviewed and found no irregularities.Based on the past similar cases, there was a possibility that the phenomenon which pointed out likely occurred due to buckling the needle tube compressively in the operating part.The causes of compression buckling might be as follows.The tube was coiled in inspection of operation.The slider was abruptly pushed.The above device handling has warned in the instruction manual as follows.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.

• Brand Name: DISPOSABLE INJECTOR NM
• 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: 10107396
• Report Number: 8010047-2020-03034
• Device Sequence Number: 19695034
• Product Code: FBK
• UDI-Device Identifier: 04953170034565
• UDI-Public: 04953170034565
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K902736
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer,foreign,health profe
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/03/2020

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-200U-0423
• Device Lot Number: 97K
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 05/19/2020
• Supplement Date Received by Manufacturer: 08/27/2020
• Initial Report FDA Received Date: 06/01/2020
• Supplement Report FDA Received Date: 09/03/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1