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

Model Number	NM-400U-0423
Medical Device Problem Code	No Flow (2991)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/25/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The subject device referenced in this report was not returned to olympus medical systems corp.(omsc) 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
It was reported that the slider of the subject device could not be moved forth during an inspection before use.The intended procedure was completed with another device.There was no patient injury reported.Olympus (b)(4) found that the needle could be moved back and forth, but the liquid could hardly be injected through the needle.This is the report regarding the failure of 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.Omsc checked the evaluation result by olympus beijing sales & service co., ltd.And confirmed that the liquid could hardly be injected through the needle.It was also confirmed that the sheath was not buckled or clogged with foreign materials.The manufacturing record was reviewed and found no irregularities.Based on the result of manufacturing record review and evaluation result by olympus beijing sales & service co., ltd., omsc presumes that the event occurred since something was clogged in the needle.The above device handling has warned in the instruction manual as follows.Before use, prepare and inspect the instrument as instructed below.Should the any irregularity be observed, do not use the instrument; use a spare instead.Damage or irregularity may compromise patient or user safety, for example:posing an infection-control risk, causing tissue irritation, perforation, bleeding or mucous membrane damage, and may result in more severe equipment damage.Inspecting injection: 1.Push the slider into the holder portion until it clicks into position to extend the needle from the distal end of the tube.2.Inject a fluid intended for patient use into the instrument¿s injection port using a sterile syringe.Confirm that the fluid comes out of the distal end of the needle.3.Make sure that the fluid is not discharged from any areas other than the distal end of the needle.

• 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: 10501399
• Report Number: 8010047-2020-06279
• Device Sequence Number: 3336560
• Product Code: FBK
• UDI-Device Identifier: 04953170259876
• UDI-Public: 04953170259876
• 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: foreign,health professional,u
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/07/2020

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-400U-0423
• Device Lot Number: K0122
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 08/27/2020
• Supplement Date Received by Manufacturer: 09/16/2020
• Initial Report FDA Received Date: 09/08/2020
• Supplement Report FDA Received Date: 10/07/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1