MAUDE Adverse Event Report: AOMORI OLYMPUS CO., LTD. SINGLE USE INJECTOR; INJECTOR AND SHEATHSET

Model Number NM-401L-0623

Device Problem Material Twisted/Bent (2981)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/10/2022

Event Type  malfunction  

Manufacturer Narrative

The investigation is ongoing and follow up with the user facility is currently being performed.A supplemental report will be submitted upon completion of the investigation or if any additional information is provided by the user facility.

Event Description

It was reported to olympus that the single use injector needle got bent during a endoscopic submucosal dissection which stopped the flow.The needle had to injected repeatedly which led to the needle being bent.The procedure was completed and there were no reports of patient harm associated with the event.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.The subject device was not returned to olympus.Therefore, the reported phenomenon and condition of the device could not be confirmed.A review of the device history record found no deviations that could have caused or contributed to the reported issue.In regards to the phenomenon ¿unable to inject liquid into the target tissue¿, the exact cause could not be conclusively identified.From a similar complaint in the past, it was likely this occurred due to the compressive bucking on the needle tube.It is unlikely a unit with defective needle is shipped as nm-401l series undergo 100% inspection for appearance, needle operation and injection.Therefore the compressive buckling on the needle tube was likely caused when the needle was extended because of the great friction between the outer tube and the needle.It was likely that the friction between the outer tube and the needle increased by the following factors: ·the needle extended/retracted while the tube was coiled in inspection of operation.·the slider was abruptly pushed.·the kink of the tube.·angle of the distal end of the endoscope in regards to the phenomenon "the needle bent", the exact cause could not be conclusively identified.A bending force might have been applied to the needle when the device was inserted into the endoscope, removed from the sterile package or during pre-inspection.This might have caused the needle to bent.The events can be prevented by following the instructions for use which state: "·the operator of this instrument must be a physician or medical personnel under the supervision of a physician and must have received sufficient training in clinical endoscopic technique.This manual does not explain or discuss clinical endoscopic procedures.·straighten out the instrument before inspecting it.The instrument can be damaged if it is coiled while the handle is operated.·operate the slider slowly, otherwise the tube could buckle.·when inserting the instrument into the endoscope, retract the needle into the sheath, hold the instrument close to the biopsy valve, and keep it as straight as possible relative to the biopsy valve.Otherwise, the instrument could be damaged.·insert the instrument slowly.Abrupt insertion could damage the endoscope and/or instrument.·stop using the instrument if the insertion portion bends excessively during use.This could result in malfunction, such as failing to extend the needle or inject a fluid." olympus will continue to monitor field performance for this device.

Manufacturer Narrative

This report is being submitted to correct the legal manufacturer¿s contact information and facility registration number.The facility registration number is 9614641.

• Brand Name: SINGLE USE INJECTOR
• Type of Device: INJECTOR AND SHEATHSET
• Manufacturer (Section D): AOMORI OLYMPUS CO., LTD.; 2-248-1 okkonoki; kuroishi-shi, aomori 036-0 357; JA 036-0357
• Manufacturer (Section G): AOMORI OLYMPUS CO., LTD.; 2-248-1 okkonoki; kuroishi-shi, aomori 036-0 357; JA 036-0357
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 16074261
• MDR Text Key: 306520961
• Report Number: 8010047-2022-12144
• Device Sequence Number: 1
• Product Code: FBK
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K902736
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 05/03/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: NM-401L-0623
• Device Lot Number: 15V
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/03/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/14/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1