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 Consequences Or Impact To Patient (2199)
Date of Event	06/07/2019
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 unspecified procedure, the subject device was used.In the procedure, the needle broke off inside the patient.The fragment was retrieved.The intended procedure was completed with another device.There was no patient injury reported.This is the report regarding the falling of the needle.
Additional Manufacturer Narrative
This is a supplemental report to provide additional information.The broken tip of the needle was returned to olympus medical systems corp.(omsc) for evaluation.The broken piece was slightly bent near the broken portion.The broken piece indicated that the needle tube broken off at about 16 mm from its distal end.The broken section of the needle tube was examined and its shape seemed that the cause of the breakage was bending load not brittleness.The manufacturing record was reviewed and found no irregularities.Based on the past similar cases, omsc presumes that the event occurred due to the following occurrence mechanism.The needle tube buckled significantly due to force to bend it, which was possibly generated by movements of the patient during the procedure.The buckled needle tube then received force to straighten it.The bending and straightening reduced the strength of the needle tube and the needle tube broke off.The above device handling has been warned in the instruction manual as follows; when inserting the instrument into the endoscope, 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 while considering such bending.Otherwise, patient injury such as perforation, bleeding, or mucous membrane damage may occur.Do not try to straighten a bent or deformed needle with your hands because the needle may break.Use a spare needle instead.Do not push the needle slider suddenly.Doing so may cause sudden needle protrusion, resulting in perforation, bleeding, mucous membrane damage.It can also damage the instrument.

• 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: 8746926
• Report Number: 8010047-2019-02380
• Device Sequence Number: 1668806
• Product Code: FCG
• UDI-Device Identifier: 04953170389894
• UDI-Public: 04953170389894
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K050503
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 10/23/2019

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 Lot Number: 8XV
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/19/2019
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 06/11/2019
• Supplement Date Received by Manufacturer: 10/07/2019
• Initial Report FDA Received Date: 06/30/2019
• Supplement Report FDA Received Date: 10/23/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1