• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. SINGLE USE ASPIRATION NEEDLE NA-220H/230H

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

OLYMPUS MEDICAL SYSTEMS CORP. SINGLE USE ASPIRATION NEEDLE NA-220H/230H Back to Search Results
Model Number UNKNOWN
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Abscess (1690)
Event Type  Injury  
Manufacturer Narrative
The subject device was not returned to olympus medical systems corp. (omsc) for evaluation. Therefore, the exact cause of the reported event could not be conclusively determined. Since the lot number is unknown, the device history record could not be reviewed. However, omsc has only shipped devices which passed the inspection. Based on the reported event, it is presumed that the reported complications were not due to the malfunction of the device, but occurred as a general complications of the procedure.
 
Event Description
On november 25, 2019, olympus medical systems corp. (omsc) received a literature titled ¿push vs pull method for endoscopic ultrasound-guided fine-needle aspiration of pancreatic head lesions: propensity score matching analysis¿. The literature reported the result of 201 cases (push group: the ratio of male-to-female ratio was 48:37. The mean age of the patients was 67. 1 years. Pull group: the ratio of male-to-female ratio was 46:39. The mean age of the patients was 67. 6 years. ) of the endoscopic ultrasound-guided fine-needle aspiration (eus-fna) of pancreatic head cancer from february 2001 to december 2017. In the literature, it was reported that olympus ultrasonic gastrovideoscope (gfy0005-uct, gf-uc240p-al5, gf-uct240-al5, and/or gf-uct260), olympus endoscopic ultrasound center (eu-me1 and/or eu-me2), and/or olympus aspiration needle (na-200h-8022, na-220h-8022, na-u200h-8022, and na-11j-kb) might be used. In the subject cases, 1 case of abscess around pancreas occurred. Based on the available information, a direct relationship between the olympus product and the observed adverse events could not be determined. This is the report regarding abscess around pancreas with the subject device.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameSINGLE USE ASPIRATION NEEDLE NA-220H/230H
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 Key9471219
MDR Text Key188804444
Report Number8010047-2019-04332
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 health professional,literatur
Reporter Occupation
Type of Report Initial,Followup
Report Date 12/19/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/16/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received11/25/2019
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

Patient Treatment Data
Date Received: 12/16/2019 Patient Sequence Number: 1
-
-