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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-8022S
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Pancreatitis (4481)
Event Date 04/01/2022
Event Type  Injury  
Manufacturer Narrative
The suspect device has not been returned to olympus for evaluation. The investigation is in process. The literature article is attached for additional information. Once the investigation has been completed, a supplemental report will be submitted with device evaluation results.
 
Event Description
Olympus reviewed the following literature "case report transjejunal endoscopic ultrasound-guided pancreatic drainage for pancreatic jejunostomy stricture using a forward-viewing echoendoscope in a patient with altered anatomy. "     literature summary: pancreatic jejunostomy stricture (pjs) is one of the major late complications after pancreaticoduodenectomy. Endoscopic ultrasound-guided pancreatic drainage (eus-pd) is considered a salvage treatment for symptomatic pjs after endoscopic retrograde pancreatography failure; however, the technical success rate of the endoscopic treatment of pjs remains unsatisfactory, mainly due to surgically altered anatomy. Herein, we describe a case of pjs successfully treated with transjejunal eus-pd using a forward-viewing echoendoscope. A (b)(6) man who suffered from repetitive severe back pain due to pjs was referred to our hospital. Since transgastric eus-pd was difficult, we attempted transjejunal eus-pd using a forward-viewing echoendoscope. To facilitate scope insertion, we first straightened the afferent jejuna! loop and placed a stiff guidewire. With this scheme, we successfully performed transjejunal eus-pd and placed a 5-fr plastic stent. In conclusion, this technique is useful for treating patients with pjs when transgastric euspd is difficult.     type of adverse events/number of patients: acute pancreatitis n
=
1.   this article includes 3 reports: patient identifier (b)(6): na-u200h-8019, the literature described "19g ez shot 3plus", we selected "na-u200h-8019" as a representative product. Patient identifier (b)(6): (b)(4). Patient identifier (b)(6): (b)(4). This report is 1 of 3 for patient identifier (b)(6): na-u200h-8019, the literature described "19g ez shot 3plus", we selected "na-u200h-8019" as a representative product.
 
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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 Key14548280
MDR Text Key292985409
Report Number8010047-2022-09111
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 07/13/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/31/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberNA-U200H-8022S
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 Received06/15/2022
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: 05/31/2022 Patient Sequence Number: 1
Treatment
UNKNOWN SERIAL: (B)(4).
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