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

Model Number NM-400U-0423

Device Problem Difficult to Insert (1316)

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

Event Date 11/22/2021

Event Type  malfunction  

Event Description

When performing a therapeutic intestinal polypectomy, the nurse attempted to perform a submucosal injection using a single use injector, however, the liquid was unable to be injected.The procedure was completed using a similar device.The customer performed a pre-use inspection to confirm that the device could inject a liquid before the procedure.The needle was extended with no problem when the slider was pushed (during procedure).There were no reports of patient harm associated with this event.

Manufacturer Narrative

The device was discarded and will not be sent in for evaluation.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation.

Manufacturer Narrative

This supplemental report is being submitted to provide additional information based on the legal manufacturer¿s investigation.As stated in the initial mdr, the subject device was not returned to olympus for evaluation, as it has been discarded by the user facility staff after use.Therefore, the reported phenomenon and condition of the device could not be confirmed.However, the legal manufacturer reviewed the device history record (dhr) and no abnormalities detected during the manufacturing of the device.There were no abnormalities detected in the dhr for the following items, which is related to the reported phenomenon: needle extension and retraction, extended length of needle, no bent/kink/crack/scratch on the tube, and injection of the liquid.The device instruction manual contains the following descriptions, and it warns against this reported event (b)(4): ¿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 the biopsy valve, and keep it as straight as possible relative to biopsy valve.Otherwise, the instrument could be damaged.Insert the instrument slowly.Abrupt insertion could damage the endoscope 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 legal manufacturer conducted a replication testing under the following four conditions and by utilizing the factory¿s inventory of nm-400u-0425.Only the needle protrusion length is different from the subject device.The difference on the needle protrusion length does not affect the investigation.Saline solution was used during the replication testing.Condition 1: buckle the tube with the needle being stored.After that, extend the needle to confirm whether a fluid can be injected.Result: an attempt was made to extend the needle after buckling the tube, however, the needle could not be extended.A fluid could be injected without any problems.Condition 2: buckle the tube with the needle being extended.After that confirm whether a fluid can injected.Result: a fluid could be injected without any problems.An attempt was made to store the needle by pulling the slider.However, the needle could not be stored.Condition 3: pierce silicone rubber multiple times to replicate the situation where foreign materials to become lodged.After that confirm whether fluid can be injected.Result: due to pressure when the fluid was injected, silicone rubber was discharged.A fluid could be injected without any problems.Condition 4: stuff foreign objects (e.G., pieces of rubber gloves) inside the injection port, after that confirm whether a fluid can be injected.Result: a fluid could be injected without any problems.Under all these conditions, the reported phenomenon of ¿not being able to inject fluid¿ could not be replicated.In conclusion, the root cause could not be determined at this time.H3 other text : device was discarded by the user facility.

• Brand Name: SINGLE USE INJECTOR
• Type of Device: 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: 13193787
• MDR Text Key: 287246359
• Report Number: 8010047-2022-01072
• Device Sequence Number: 1
• Product Code: FBK
• UDI-Device Identifier: 04953170259876
• UDI-Public: 04953170259876
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 04/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/07/2022
• 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: 07KA
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/28/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: ADRENALINE; NORMAL SALINE
• Patient Age: 51 YR
• Patient Sex: Female