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

Model Number NA-U401SX-4021

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/23/2018

Event Type  malfunction  

Manufacturer Narrative

The subject device was returned to olympus medical systems corp.(omsc).The needle was sticking out.The exact cause has been under investigation.A supplemental report will be submitted, if additional or significant information becomes available at a later time.

Event Description

During an unspecified procedure, the subject device was used.Although the user tried to retract the needle of the subject device, the needle could not be retracted into the sheath.No patient injury was reported.This is the report regarding the inability to retract the needle.

Manufacturer Narrative

This is a supplemental report to provide additional information.The subject device was returned to olympus medical systems corp.(omsc) for investigation.As a result of the investigation on (b)(6) 2018, it was found that the needle was detached from the needle slider.The needle was buckled around the cutting point.The manufacturing record was reviewed and found no irregularities.Based on the past similar cases, the needle might be unable to retract into the sheath because the needle was detached from the needle slider.It is assumed that the detachment of the needle from the needle slider was caused by the following mechanism; the needle was buckled when the subject device was taken out from the sterile package, when it was inserted into the endoscope, or when it was withdrawn from the endoscope.The needle could not be moved due to the buckling.The user pulled the needle slider using excessive force to retract the needle.The detachment of the needle occurred because the needle was subjected to an excessive load.The instruction manual of the device has already warned as follows; 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.

• Brand Name: SINGLE USE ASPIRATION NEEDLE NA-U401SX
• Type of Device: SINGLE USE ASPIRATION NEEDLE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to
• Manufacturer Contact: kazutaka matsumoto ; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8-507 ; JA 192-8507 ; 426425177
• MDR Report Key: 7787895
• MDR Text Key: 117287840
• Report Number: 8010047-2018-01590
• Device Sequence Number: 1
• Product Code: FCG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K160098
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/16/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: NA-U401SX-4021
• Device Lot Number: 83K
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/01/2018
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/17/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/29/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1