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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 Problems Break (1069); Device Fell (4014)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 04/18/2020
Event Type  malfunction  
Manufacturer Narrative
The device has not been returned for evaluation, the needle sheath/deployment apparatus and packaging was discarded. A photo of the needle tip was provided for investigation. The cause of the needle breaking could not be determined. No further information was reported. Based on similar reported complaints, the most likely cause of the reported phenomenon can be attributed to user handling or technique. The instruction manual states "if you feel excessive resistance while operating the needle, do not push the needle slider forcibly. Doing so could cause patient injury, such as perforation, bleeding, or mucous membrane damage. It could also damage the instrument and/or endoscope".
 
Event Description
The customer reported to olympus that during a bronchoscopic biopsy procedure the distal end of the needle fractured in the patient's airway. The node had a suspected fibrotic capsule, and as such was more difficult to penetrate than usual. The intended procedure was terminated after a failed final biopsy pass. The needle fracture was not recognized until a few days later when the patient coughed out the needle tip. Subsequent chest imaging revealed no other residual foreign body in the airway. There was no patient injury reported.
 
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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 Key10018251
MDR Text Key225207242
Report Number8010047-2020-02443
Device Sequence Number1
Product Code FCG
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K050503
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,user faci
Reporter Occupation
Type of Report Initial,Followup
Report Date 10/16/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/01/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberNA-201SX-4021
Device Lot Number98V
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received09/24/2020
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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