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

Model Number UNKNOWN

Device Problem Insufficient Information (3190)

Patient Problems Fever (1858); Unspecified Infection (1930)

Event Type  Injury  

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 "forward-viewing versus oblique-viewing echoendoscopes in the diagnosis of upper gi subepithelial lesions with eus-guided fna: a prospective, randomized, crossover studyl". The literature reported the result of 78 patients of the endoscopic ultrasound-fine needle aspiration (eus-fna) procedure using olympus "ez shot2" from january 2013 to may 2014. In the subject cases, infection and fever occurred in 1 patient. Omsc will submit a medical device reports (mdr) depending on the event.

• Brand Name: SINGLE USE ASPIRATION NEEDLE NA-220H/230H
• Type of Device: SINGLE 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 Key: 10790535
• Report Number: 8010047-2020-08564
• Device Sequence Number: 1
• Product Code: FCG
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K023272
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature

Reporter Occupation

• Type of Report: Initial
• Report Date: 11/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/05/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Model Number: UNKNOWN
• 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 Received: 10/13/2020
• 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 Outcome(s): Other