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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. SINGLE USE INJECTOR; INJECTOR AND SHEATHSET
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OLYMPUS MEDICAL SYSTEMS CORP. SINGLE USE INJECTOR; INJECTOR AND SHEATHSET Back to Search Results
Model Number NM-401L-0425
Medical Device Problem Code Failure to Infuse (2340)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 03/11/2020
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
During dispensing a botox in the bladder, the subject device was used.In the procedure, the needle could not inject botox into the tissue.It was reported that the user error might occur.The intended procedure was completed with another device.There was no patient injury reported.This is the report of the inability of injection.
 
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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 Key9941707
Report Number8010047-2020-02069
Device Sequence Number13622831
Product Code FBK
UDI-Device Identifier04953170382345
UDI-Public04953170382345
Combination Product (Y/N)N
Initial Reporter CountryUK
PMA/510(K) Number
K902736
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source foreign,health professional,u
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 04/09/2020
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 Health Professional
Device Model NumberNM-401L-0425
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 03/11/2020
Initial Report FDA Received Date04/08/2020
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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