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

Model Number	NA-201SX-4022
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/24/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The needle device is in quarantine at the customer site.Neither the needle device nor the endoscope is available for olympus evaluation.The cause of the reported complaint cannot be confirmed.The procedure was completed using another needle device, per the instruction manual recommendation to ¿always have a spare instrument available in case the primary instrument malfunctions.¿ as a preventive measure against breakage, the instruction manual warns, ¿do not use an aspiration needle that has an irregularly bent or deformed needle tube.¿ ¿do not apply bending force to the handle section.Doing so may damage the instrument and/or endoscope.¿ ¿do not coil the insertion portion with a diameter of less than 150 mm.Doing so could damage the instrument.¿ and ¿do not try to straighten a bent or deformed needle with your hands because the needle may break.¿ the instruction manual also has directions for pre-procedure visual inspection and functional verification of the needle device.
Event or Problem Description
Olympus was informed that in the middle of an ebus procedure, the needle broke off into the patient¿s lung, at station 4r on the anterior tracheal wall.The breakage was discovered when the needle device was removed from the patient for making slides of the sample during the procedure.The broken off piece was retrieved with a snare.There was no reported patient injury.The procedure was completed with another needle device.

• Brand Name: SINGLE USE ASPIRATION NEEDLE
• 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: 7603629
• Report Number: 2951238-2018-00354
• Device Sequence Number: 1623714
• Product Code: FCG
• UDI-Device Identifier: 04953170180934
• UDI-Public: 04953170180934
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K050503
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/14/2018

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: Health Professional
• Device Model Number: NA-201SX-4022
• Device Catalogue Number: NA-201SX-4022
• Device Lot Number: 6YZ
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/24/2018
• Initial Report FDA Received Date: 06/14/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 66 YR
• Patient Weight: 119