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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-4021
Device Problem Device Fell (4014)
Patient Problem Foreign Body In Patient (2687)
Event Date 05/12/2021
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. A supplemental report will be submitted, if additional or significant information becomes available at a later time.
 
Event Description
Olympus medical systems corp. (omsc) was informed by the health professional that during an endobronchial ultrasound-guided transbronchial needle aspiration (ebus-tbna) using the subject device, the following event occurred. After 2 punctures in lymph node #10r, the device (needle) penetrated through the sheath of the device and the endoscope at the third puncture. The tip of needle snapped off and remained inside the patient node. It was able to see the needle tip on the endoscope image. The health professional did not retrieve it with some biopsy forceps because the professional decided it would be too risky. The patient is going to be sent to another hospital to see a thoracic surgeon, to remove it. It was reported also that the patient feels fine, is in no pain, and has no issue going to another hospital.
 
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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 Key11927543
MDR Text Key266087054
Report Number8010047-2021-07026
Device Sequence Number1
Product Code FCG
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
K050503
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 09/29/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/03/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberNA-201SX-4021
Device Lot Number12V19
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/06/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received09/14/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/19/2021
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: 06/03/2021 Patient Sequence Number: 1
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