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

Model Number	NA-U401SX-4022
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/03/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The subject device referenced in this report was not returned to olympus for evaluation.Therefore the exact cause of the reported event could not be conclusively determined at this time.A supplemental report will be submitted, if additional or significant information becomes available at a later time.
Event or Problem Description
During an endobronchial ultrasonography, the subject device was used.In the procedure, the user found that the tube sheath was broken.And the user could not retract the needle into the tube sheath.The user could not take out the subject device from the endoscope.The user took out the endoscope from the patient while the subject device with the extended needle left in the endoscope.No further information was provided.This is the report regarding the inability to retract the needle.
Additional Manufacturer Narrative
This is a supplemental report to provide additional information.The subject device was returned to olympus medical systems corp.(omsc) for evaluation.The sheath of the subject device was partially turned up.The needle tube was detached from the needle slider.There was no abnormality of the bonding condition at the needle tube fixing part.The needle tube could not be retracted into the sheath.There were no other abnormalities that could lead to the reported event.The manufacturing record was reviewed and found no irregularities.Based on the past similar cases, it was known that the needle could not be retracted into the sheath because the needle tube was detached from the needle slider.It is assumed that the detachment of the needle tube from the needle slider was caused by the following mechanism; (1) the sliding resistance between the needle tube and the sheath was increased since the insertion portion was angulated inside the endoscope.(2) the user pulled the needle slider with excessive force and the needle was subject to an excessive load.As a result, the needle detached from the needle slider.The above device handling has warned in the instruction manual as follows.Do not coil the insertion portion with a diameter of less than 150 mm.Doing so could damage the instrument.Do not insert this instrument when the endoscope is angulated.This could damage the endoscope and/or this instrument.Do not insert the instrument abruptly.This could cause patient injury, such as perforation, bleeding, or mucous membrane damage.It could also damage the endoscope and/or the instrument.Do not force the instrument if resistance to insertion is encountered.Reduce the angulation of the endoscope until the instrument passes smoothly.Attempting to force the instrument could cause patient injury, such as perforation, bleeding, or mucous membrane damage.It could also damage the endoscope and/or the instrument.
Additional Manufacturer Narrative
This is a supplemental report to provide additional information.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.The lot number of the subject device is unknown.As a result of checking the manufacturing record for the past one year from the event date, it was found no irregularities.Based on the past similar cases, omsc assumed that the reported event occurred due to the following causes.The sheath was broken since it was inserted and/or withdrawn when the endoscope was excessively angulated.The sliding resistance between the needle tube and the sheath was increased due to the angulated endoscope.When retracting needle tube into the sheath by excessive force, a load was applied to the needle tube joint of the aspiration port.The needle tube was detached from the port and it could not be retracted into the sheath.The needle tube was difficult to withdraw from the endoscope since the buckled part of the sheath got stuck inside the endoscope.The above device handling has warned in the instruction manual as follows.Do not coil the insertion portion with a diameter of less than 150 mm.Doing so could damage the instrument.Do not insert this instrument when the endoscope is angulated.This could damage the endoscope and/or this instrument.Do not insert the instrument abruptly.This could cause patient injury, such as perforation, bleeding, or mucous membrane damage.It could also damage the endoscope and/or the instrument.Do not force the instrument if resistance to insertion is encountered.Reduce the angulation of the endoscope until the instrument passes smoothly.Attempting to force the instrument could cause patient injury, such as perforation, bleeding, or mucous membrane damage.It could also damage the endoscope and/or the instrument.

• Brand Name: SINGLE USE ASPIRATION NEEDLE NA-U401SX
• Common Device Name: SINGLE 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 Key: 9421324
• Report Number: 8010047-2019-04184
• Device Sequence Number: 14076286
• Product Code: FCG
• UDI-Device Identifier: 04953170388286
• UDI-Public: 04953170388286
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K160098
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: No Information
• Device Model Number: NA-U401SX-4022
• Device Lot Number: PW305225
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/16/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 12/03/2019
• Supplement Date Received by Manufacturer: 03/12/2020; 03/25/2020
• Initial Report FDA Received Date: 12/06/2019
• Supplement Report FDA Received Date: 03/22/2020; 04/14/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1