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

Model Number NM-221C-0427

Device Problem Infusion or Flow Problem (2964)

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

Event Date 05/19/2023

Event Type  malfunction  

Event Description

A customer reported to olympus, a nurse was unable to inject botox into the single use injector.When the device was removed a small kink at the top of tubing was found.The event occurred during a therapeutic injection of botox into bladder.The procedure was delayed for 2 minutes and completed by replacing the device.There was no report of patient harm associated with this event.

Manufacturer Narrative

The subject device was discarded by the customer.A photograph of the subject device showed the needle tube being kinked.A review of the device history record (dhr) found no deviations that could have caused or contributed to the reported malfunction.The dhr confirmed that the subject device was shipped in accordance with the specifications.A definitive root cause could not be determined.The exact cause ¿unable to inject liquid into the target tissue¿ could not be conclusively identified, because the device was not returned for evaluation and there were no abnormalities on the device in the device history record.The instruction manual provides the following: ¿¿before use, prepare and inspect the instrument as instructed below.Should any irregularity be observed, do not use the instrument.Use a spare instead.·do not withdraw the stylet before locking the sheath section and the needle section together by positioning the slider at the 1st click stop position.Otherwise the tube could buckle when the needle section is inserted into the sheath section.·operate the slider slowly.Otherwise, the tube could buckle.·be sure to use a fluid intended for patient use when inspecting injection.If other fluids are used, the fluids may remain in the instrument.This could pose an infection control risk or cause tissue irritation.·insert the instrument slowly.Abrupt insertion could damage the endoscope and/or instrument.¿do not push in the slider abruptly.The needle may extend abruptly.This could cause patient injury, such as perforations, hemorrhages or mucous membrane damage.¿ olympus will continue to monitor field performance 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: 17083634
• MDR Text Key: 317226596
• Report Number: 9614641-2023-00814
• Device Sequence Number: 1
• Product Code: FBK
• UDI-Device Identifier: 04953170414978
• UDI-Public: 04953170414978
• Combination Product (y/n): N
• Reporter Country Code: NZ
• PMA/PMN Number: K192498
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/07/2023

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
• Device Operator: Health Professional
• Device Model Number: NM-221C-0427
• Device Lot Number: 31K
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/19/2023
• Initial Date FDA Received: 06/07/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/31/2022
• 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: FLEXIBLE CYSTOSCOPE