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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-U401SX

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OLYMPUS MEDICAL SYSTEMS CORP. SINGLE USE ASPIRATION NEEDLE NA-U401SX Back to Search Results
Model Number NA-U401SX-4021
Device Problems Break (1069); Physical Resistance/Sticking (4012)
Patient Problem Insufficient Information (4580)
Event Date 10/04/2021
Event Type  Injury  
Event Description
The customer reports during an endobronchial ultrasound (ebus) procedure using a single use aspiration needle na-u401sx, "an entire needle somehow broke off (we¿re not sure how, the case wasn¿t difficult) and ended up getting stuck in the trachea. " the detached needle was discovered in the patient¿s trachea 16 days after the ebus procedure during a cyberknife treatment. Two days after it¿s discovery, the retained needle removed in the operating room via rigid bronchoscopy (and was discarded). The patient was hospitalized in the intensive care unit (icu) post procedure and was discharged three days later. No further consequences to the patient have been reported. The bronchoscope used in the ebus procedure did not malfunction in any way. There were no procedural or anatomical challenges that could have contributed to the reported event.
 
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Brand NameSINGLE USE ASPIRATION NEEDLE NA-U401SX
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
MDR Report Key12838238
MDR Text Key281005232
Report Number2951238-2021-00440
Device Sequence Number1
Product Code FCG
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Reporter Occupation
Type of Report Initial
Report Date 10/26/2021,11/18/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/18/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberNA-U401SX-4021
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Distributor Facility Aware Date10/26/2021
Event Location Hospital
Date Report to Manufacturer10/26/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 11/18/2021 Patient Sequence Number: 1
Treatment
UNSPECIFIED BRONCHOSCOPE
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