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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. SINGLE USE ASPIRATION NEEDLE NA-U200H

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OLYMPUS MEDICAL SYSTEMS CORP. SINGLE USE ASPIRATION NEEDLE NA-U200H Back to Search Results
Model Number NA-U200H-8022
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Pancreatitis (4481)
Event Date 02/04/2022
Event Type  Injury  
Event Description
It is reported in the literature titled: "a case of high grade pancreatic intraepithelial neoplasia diagnosed by endoscopic ultrasound-guided fine needle aspiration, " the patient experienced mild pancreatitis. This literature is a case report of high grade pancreatic intraepithelial neoplasia diagnosed by endoscopic ultrasound-guided fine needle aspiration (eus-fna). The patient was a (b)(6) man who came for a checkup. Main pancreatic duct (mpd) dilatation was observed on abdominal ultrasonography. His tumor marker levels were normal. Contrast-enhanced computed tomography showed a dilated caudal mpd and pancreatic parenchyma atrophy, consistent with the interruption of the mpd in the pancreatic body. Magnetic resonance cholangiopancreatography revealed caudal mpd dilatation and a small cystic lesion around the mpd stenosis. Endoscopic ultrasound (eus) showed a faint 10-mm hypoechoic area around the pancreatic duct with indistinct borders, irregular contours, and heterogeneous internal echogenicity. High grade pancreatic intraepithelial neoplasia or minimally invasive carcinoma was suspected. Endoscopic pancreatography revealed a 20-mm stenosis in the mpd; endoscopic nasopancreatic drainage and subsequent pancreatic juice cytology were performed. All samples were classified as class iii. Eus-fna was performed to evaluate the faint hypoechoic area in order to exclude malignancy. Four punctures were performed using ez-shot3 plus22g the patient developed mild pancreatitis that improved with conservative treatment. There is no report of olympus device malfunction.
 
Manufacturer Narrative
The device referenced in this report has not been returned to olympus for evaluation. The investigation is ongoing. The definitive cause of the user¿s experience cannot be determined at this time. This report will be updated upon completion of the investigation or upon receipt of additional relevant information.
 
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Brand NameSINGLE USE ASPIRATION NEEDLE NA-U200H
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 Key13714468
MDR Text Key291355882
Report Number8010047-2022-04186
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 Other,Foreign,Study,Literature,Health Professional
Reporter Occupation
Type of Report Initial,Followup
Report Date 08/09/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/09/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberNA-U200H-8022
Device Lot NumberUNKNOWN(LITERATURE)
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received07/28/2022
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: 03/09/2022 Patient Sequence Number: 1
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