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

Model Number NM-400U-0423

Device Problems Failure to Deliver (2338); Failure to Infuse (2340)

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

Event Date 11/23/2022

Event Type  malfunction  

Event Description

It was reported the physician tried to puncture the colonic mucosa with the injection needle nm-400u-0423 during a therapeutic endoscopic mucosal resection (emr) procedure, however it was very difficult to puncture.According to the report, although the injection needle could be punctured into the mucosa, saline could not be delivered.The device was replaced and the intended procedure was completed using a similar device.No harm was reported, no patient harm, no user injury reported due to the event.

Manufacturer Narrative

Customer returned two (2) pieces of the model no.Nm-400u-0423 with same lot number 11v.According to the facility, one is a defective product and the other is a procedure-completed product (not subject to complaint).The subject device was evaluated.Device evaluation, the following were noted: the lot number was 11v with supplementary information number of ¿25¿.(m-bc manufacture date: january 25th, 2021).Device evaluation observed the tube was buckled at 150mm from the distal end.Based on product specifications, the subject device was combined with the endoscope under the following condition.The test was carried out and confirmed if the needle can pierce a silicone plate instead of mucous membrane.The state where it makes a loop with 120mm inscribed at 250mm from the distal end.The tip of the needle was inspected using a magnifier.Adhesion of foreign materials were observed.However, no abnormalities that could lead to chipping of the needle or failure of piercing were observed.An attempt was made to inject a fluid using an olympus syringe (reference syringe).However, the fluid stopped moving at the buckling area.No other abnormalities that could lead to the phenomenon of the reported event could not be confirmed.Instruction for use (ifu): the instruction manual contains the following descriptions, and it warns against this event.(rk1555 rev02.) ·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.The dhrs (device history records) for this product have been reviewed.No abnormalities were detected in the device history record with the lot number for the following inspection items which related to the reported phenomenon.Process inspection.Quality inspection.Nonconforming product report.Conclusion summary: piercing failure ( difficult to puncture ) could not be confirmed.No abnormalities that could lead to chipping of the needle or failure of piercing (difficult to puncture) were observed.However, buckling of the tube prevented from a saline from moving at the buckling area observed.This might have caused the reported phenomenon (phenomenon details: a saline could not be injected).A bending force might have been applied to the tube under the following circumstances causing the reported event: buckling of the tube possibly occurred: when the device was inserted into the endoscope.When the device was removed from the sterile package.During pre-use inspection.The needles undergo 100% appearance inspection and function inspection during production process.Therefore, it is determined that handling the device at the facility might have contributed to the reported event.Olympus will continue to monitor complaints for this device.

• 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: 16031790
• MDR Text Key: 308551411
• Report Number: 9614641-2022-00836
• Device Sequence Number: 1
• Product Code: FBK
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K902736
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 12/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: NM-400U-0423
• Device Lot Number: 11V25
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/29/2022
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/24/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/25/2021
• 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
• Treatment: SALINE SOLUTION