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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. SINGLE USE ASPIRATION NEEDLE

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OLYMPUS MEDICAL SYSTEMS CORP. SINGLE USE ASPIRATION NEEDLE Back to Search Results
Model Number NA-201SX-4022
Device Problem Break
Event Date 06/07/2019
Event Type  Malfunction  
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 Description

During an unspecified procedure, the subject device was used. In the procedure, the needle broke off inside the patient. The fragment was retrieved. The intended procedure was completed with another device. There was no patient injury reported. This is the report regarding the falling of the needle.

 
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Brand NameSINGLE USE ASPIRATION NEEDLE
Type of DeviceSINGLE USE ASPIRATION NEEDLE
Manufacturer (Section D)
OLYMPUS MEDICAL SYSTEMS CORP.
2951 ishikawa-cho
hachioji-shi, tokyo-to 192-8 507
JA  192-8507
Manufacturer Contact
kazutaka matsumoto
2951 ishikawa-cho
hachioji-shi, tokyo-to  192-8-507
  192-8507
426425177
MDR Report Key8746926
Report Number8010047-2019-02380
Device Sequence Number1
Product CodeFCG
Report Source Manufacturer
Source Type FOREIGN,HEALTH PROFESSIONAL,U
Reporter Occupation PHARMACIST
Type of Report Initial
Report Date 07/01/2019
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received06/30/2019
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberNA-201SX-4022
Device LOT Number8XV
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received06/11/2019
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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