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U.S. Department of Health and Human Services

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

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OLYMPUS MEDICAL SYSTEMS CORP. SINGLE USE ASPIRATION NEEDLE Back to Search Results
Model Number NA-201SX-4022
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Abscess (1690); Fever (1858)
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 serial number is unknown, the device history record could not be reviewed. However, omsc has only shipped devices that passed the inspection. In the literature, there is no description of the device's malfunction.
 
Event Description
Olympus medical systems corp. (omsc) received a literature titled "evaluation of the safety and efficacy of minimal endoscopic sphincterotomy followed by papillary balloon dilation for the removal of common bile duct stones". The literature reported the result of 435 patients with mediastinal and hilar lymphadenopathy who underwent endobronchial ultrasound-guided transbronchial needle aspiration (ebus-tbna) procedure using the olympus na-201sx-4022 from may 2010 to july 2012. In the literature, it was reported complication as follows; fever after ebus-tbna (110 cases). Blood culture samples positive (2 cases): the identified organism was normal flora of the skin and there was no true bacteremia. Pneumonia (2 cases). Mediastinal abscess (1 case): a (b)(6) female patient with underlying diabetes mellitus developed fever 3 days after the procedure, at which time she was diagnosed with mediastinal abscess. After 7 days of antibiotic therapy, the patient became afebrile. The patient was successfully treated with antibiotics for 6 weeks. Omsc assumes that the mediastinal abscess was a serious injury due to the required 7days of antibiotic therapy. There are not mentioned that these complications were related to the subject device in question. However, omsc assumes that "mediastinal abscess" might be related to "na-201sx-4022" due to the procedure using "na-201sx-4022". Based on the available information, specific information on the subject device and the patients were not provided. There is no description of the device's malfunction. Therefore, omsc assumes that the "mediastinal abscess" was adverse events to submit due to the required 7days of antibiotic therapy. Omsc will submit a medical device report (mdr) of the subject device for the "mediastinal abscess".
 
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Brand NameSINGLE USE ASPIRATION NEEDLE
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 Key12286210
MDR Text Key265364946
Report Number8010047-2021-09886
Device Sequence Number1
Product Code FCG
Combination Product (y/n)N
Reporter Country CodeKS
PMA/PMN Number
K050503
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,literature
Reporter Occupation
Type of Report Initial
Report Date 08/06/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/06/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberNA-201SX-4022
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 Received07/12/2021
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: 08/06/2021 Patient Sequence Number: 1
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