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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-200H-8022
Device Problem Insufficient Information (3190)
Patient Problem Death (1802)
Event Type  Death  
Manufacturer Narrative
The subject device was not returned to olympus medical systems corp (omsc). The malfunction of the subject device concerning this case has not been reported. The exact cause could not be determined. If additional information becomes available, this report will be supplemented.
 
Event Description
Olympus medical systems corp. (omsc) received a literature titled "non-negligible rate of needle tract seeding after endoscopic ultrasound-guided fine-needle aspiration for patients undergoing distal pancreatectomy for pancreatic cancer". The literature reported the result of 176 patients with invasive pancreatic ductal cancers of the endoscopic ultrasound-guided fine needle aspiration (eus-fna) procedure using olympus single use aspiration needle na-200h-8022 or non-olympus needle from january 2006 and december 2015. In the subject case, 6 cases of needle tract seeding occurred during the 5 year follow up, and 3 of them died of recurrent tumors. The subject device was used in one of the six procedures. However, it is unknown in which case it was used, and it is also unknown whether it was used in deceased patients. Omsc will submit a medical device report (mdr) depending on the event.
 
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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 Key11346027
MDR Text Key232509019
Report Number8010047-2021-02848
Device Sequence Number1
Product Code FCG
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K023272
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type literature
Reporter Occupation
Type of Report Initial
Report Date 02/19/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/18/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberNA-200H-8022
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 Received02/03/2021
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

Patient Treatment Data
Date Received: 02/18/2021 Patient Sequence Number: 1
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