• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. SINGLE USE ASPIRATION NEEDLE NA-U401SX

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

OLYMPUS MEDICAL SYSTEMS CORP. SINGLE USE ASPIRATION NEEDLE NA-U401SX Back to Search Results
Model Number NA-U401SX-4021
Device Problem Break (1069)
Patient Problem Needle Stick/Puncture (2462)
Event Date 02/14/2019
Event Type  malfunction  
Manufacturer Narrative
The device was not returned to olympus for evaluation. The cause of the reported complaint cannot be confirmed. A potential cause is failure to follow instructions for use. It was reported that during the procedure the needle was seen bent but was used anyway prior to the breakage. The needle instruction manual has warnings that address bent needles: ¿do not use an aspiration needle that has an irregularly bent or deformed needle tube. Otherwise, unexpected perforation, bleeding, or mucous membrane damage may occur. ¿when inserting the instrument, the distal end of the needle tube may be bent. When piercing the target, confirm the distal end of the sheath and needle tube in the endoscopic field of view and/or ultrasound image. Do not try to straighten a bent or deformed needle with your hands because the needle may break. Use a spare needle instead. ¿as a preventive measure, the instruction manual for the device has directions for pre-procedure visual and functional inspection, including explicit instructions to look for deformation at the distal end. The instruction manual also advises, "always have a spare instrument available in case the primary instrument malfunctions. ¿.
 
Event Description
Olympus was informed that during an endobronchial ultrasound bronchoscopy (ebus) procedure, while performing the needle biopsy of the lymph node (station4r) the needle broke in half inside the patient. The broken needle was sticking out from the patient¿s tracheal wall and the doctor removed it with forceps. It was reported that there were two successful passes of the biopsy needle with no insertion issues and then broke during the third pass. There was no tissue trauma from the retrieval of the needle. The doctor withdrew the needle through the inside of the scope and then withdrew the scope. There was no additional medical or surgical intervention needed for the patient as a result of the event. The patient was in a stable condition and discharged home the same day. Additionally, the user facility reported that there was no damage to the scope. The needle and other equipment used were inspected prior to use and no anomalies were found.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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
Manufacturer Contact
connie tubera
2400 ringwood avenue
san jose, CA 95131
4089355124
MDR Report Key8410586
MDR Text Key141330031
Report Number2951238-2019-00530
Device Sequence Number1
Product Code FCG
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K160098
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup
Report Date 01/31/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/11/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberNA-U401SX-4021
Device Lot NumberPW305218
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received01/30/2020
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

-
-