MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. SINGLE USE INJECTOR; INJECTOR AND SHEATHSET

Model Number	NM-401L-0425
Medical Device Problem Code	Failure to Fire (2610)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/01/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is discarded and will not be returned; as such a definitive root cause of the reported complaint cannot be determined at this time.This event is under investigation.A supplemental report will be submitted upon completion of the investigation or upon receiving additional information.
Event or Problem Description
As reported for this event by the customer, during a therapeutic esophagoduodenoscopy with dilatation and therapeutic injection (mytomicin), the device 0.1 ml of mitocycin was injected by pushing the injector twice.However, the medicine did not pass through with the third push.The procedure was completed using a similar device.There is no reported harm or adverse impact to the patient.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.A review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been over 1 year since the subject device was manufactured.Based on the results of the investigation, the exact cause could not be conclusively identified as the device was not returned.However, it is likely that the phenomenon occurred due to the compressive bucking on the needle tube.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.The instruction manual contains the following descriptions, and it warns against this event.(rk1556 rev.01) 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.
Additional Manufacturer Narrative
Additional information has been received from the customer.This supplemental report is being submitted to provide this information.
Event or Problem Description
Addendum (b)(6) 2022: a device had been used prior to this device in the procedure.The earlier device had failed by the needle being stuck and not coming into the sheath.There was a delay in the procedure as more than 15 minutes were required to prime, inject, and re-check the two devices that failed during the procedure.It takes approximately five to ten minutes from priming to giving the patient injection.The procedure lasted for an hour in total, so the patient was most likely given more anesthesia.Addendum (b)(6) 2022: there was no harm or injury to the patient due to this event.There was no change to the patient¿s post-operative treatment course due to the device malfunctions or procedural delay.The procedure was completed, however, the full intended dosage of the medicine was not injected in the patient due to the event.

• Brand Name: SINGLE USE INJECTOR
• Common Device Name: INJECTOR AND SHEATHSET
• 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: 14115770
• Report Number: 8010047-2022-06361
• Device Sequence Number: 19569090
• Product Code: FBK
• UDI-Device Identifier: 04953170260070
• UDI-Public: 04953170260070
• Combination Product (Y/N): N
• Initial Reporter Country: QA
• PMA/510(K) Number: K902736
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/01/2022

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
• Operator of Device: Health Professional
• Device Model Number: NM-401L-0425
• Device Lot Number: 0ZK
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/23/2022
• Supplement Date Received by Manufacturer: 04/21/2022; 06/02/2022
• Initial Report FDA Received Date: 04/14/2022
• Supplement Report FDA Received Date: 05/19/2022; 07/01/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/01/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Male