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

Model Number NA-U401SX-4022

Device Problem Break (1069)

Patient Problems Foreign Body In Patient (2687); Cough (4457)

Event Date 06/23/2021

Event Type  malfunction  

Manufacturer Narrative

The subject device was not returned to olympus medical systems corp.(omsc) for investigation.According to the picture provided, breakage of the needle tube was confirmed.The device history record for the lot indicated no anomaly with the event-related items.The record includes the following.Sheath appearance.Needle tube appearance.The subject device was not returned for investigation.However, based on the similar investigation result in the past, it is possible to infer its cause from the description.Therefore, it was decided that it was not necessary to perform an investigation by using a device with the same structure or a similar device.The exact cause of the problem could not be conclusively identified, since the device was not retuned for the investigation.No abnormalities were found in the manufacturing record.Therefore, the phenomenon which was pointed out could not be confirmed.From the confirmation result of the actual product and the past investigation result, it is estimated that the needle tube was broken by the following mechanism.A bending force was applied to the needle tube when a needle tube was pierced into a hard tissue.This caused the needle tube to bend excessively.A force was applied to the bent needle when the needle slider was pulled, and it straightened the needle tube.As a result, the needle tube broke.However, the exact cause of the needle break could not be identified.After checking the contents of the instruction manual (drawing number rk1001, revision number 3), the following caution was issued regarding the description related to this event.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.

Event Description

Olympus medical systems corp.(omsc) was informed by a clinical staff that during a procedure of an endoscopic bronchial ultrasound using the subject device as follows.¿we have an ebus needle that during a procedure could not retract and when it was retracted the needle had broken off.Needle failed to retract during procedure, needle removed from patient and scope and found piece of needle missing during a bronch procedure the patient gets sprayed with novocaine spray to numb the vocal cords and usually have no feeling is surrounding area.Coughing is mostly a reflex reaction.They were looking for the needle in the lungs with a scope, when they retrieved the scope she coughed and then swallowed.They assume that¿s when she swallowed it.She was then sent to ct and a gastroscopy, they did not find it in the stomach.The patient underwent a ct scan on saturday morning at that stage the needle test was in the sigmoid.¿ also, it was informed by a nurse as follows.¿wednesday 23 june - needle broke off in patient.Thursday 24 june - olympus representative collected defective product (we were told at the time that the patient was admitted and under observation in hdu).Gastroscopy was performed to retrieve needle in the stomach but has moved into deodenum.Saturday 26 june ¿ patient had mri.Needle in sigmoid and looked like it was about to be expelled.The nurse said that they were expecting her to expel the needle late saturday or early sunday morning.Friday 2 july - patient had x- and no sign of needle.The hospital is no longer concerned.¿.

• 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 192-8 507; JA 192-8507
• Manufacturer Contact: kazutaka matsumoto ; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8-507 ; JA 192-8507 ; 426425177
• MDR Report Key: 12178866
• MDR Text Key: 261911993
• Report Number: 8010047-2021-08935
• Device Sequence Number: 1
• Product Code: FCG
• UDI-Device Identifier: 04953170388286
• UDI-Public: 04953170388286
• Combination Product (y/n): N
• Reporter Country Code: NZ
• PMA/PMN Number: K160098
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/15/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: NA-U401SX-4022
• Device Lot Number: 11K
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/24/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/23/2021
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization