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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 Problems Hemorrhage/Bleeding (1888); Perforation (2001); Pancreatitis (4481)
Event Type  Injury  
Manufacturer Narrative
The suspect device has not been returned to olympus for evaluation. The investigation is in process. Once the investigation has been completed, a supplemental report will be submitted with device evaluation results.
 
Event Description
Olympus reviewed the following literature: examination of needles used for eus-fna in our hospital. [literature summary] needles used for eus-fna are being improved daily, in fna. There are various reports on the selection of needles, and it is difficult to select one from various options. The selection of a puncture needle for reliable sample collection needs to be examined from various points of view. [type of adverse events / number of patients] there were 8 complications in total (1 case of perforation with francine needle, 1 case of bleeding, 1 case of intraductal bleeding with fork tip needle, 1 case of pancreatitis, 3 cases of pancreatitis with lancet needle, 1 case of bleeding). One case of bleeding that required angio was a case of splenic artery injury when punctured with 19g. The product was unknown but a representative product was chosen for processing purposes. (na-u200h-) 8022).
 
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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 Key14656103
MDR Text Key294771983
Report Number8010047-2022-09845
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,Literature,Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 07/11/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/10/2022
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 Received06/17/2022
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: 06/10/2022 Patient Sequence Number: 1
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