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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
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Inflammation (1932)
Event Type  Injury  
Manufacturer Narrative
The subject device was not returned to olympus medical systems corp. (omsc). The author has not reported additional information about individual cases. Since the lot number is unknown, the manufacturing history record could not be reviewed. However, omsc has only shipped devices which passed the inspection. From the reported information, we presume that the reported complications were not due to the malfunction of the device, but occurred as "a" general "complications" of the procedure.
 
Event Description
In the lectures of the japan digestive disease week 2018, it was reported the following contents. Lectures: study of the efficacy of eus-fna using the new franseen needle for pancreatic solid tumors. Summary: during the procedures of eus-fna for pancreatic solid tumors, olympus ez shot 3 plus and the other companies devices were used. These devices were used in 62 procedures. In one of 62 procedures, pancreatitis occurred. This is the report regarding pancreatitis.
 
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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
JA   192-8507
426425177
MDR Report Key8093850
MDR Text Key128033026
Report Number8010047-2018-02269
Device Sequence Number1
Product Code FCG
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K151738
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,literatur
Reporter Occupation
Type of Report Initial
Report Date 11/21/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/21/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received11/01/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/01/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 11/21/2018 Patient Sequence Number: 1
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