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

Model Number NM-401L-0423

Device Problem Infusion or Flow Problem (2964)

Patient Problem Nausea (1970)

Event Date 04/07/2021

Event Type  malfunction  

Manufacturer Narrative

The subject device was returned to olympus¿s local distributor, but not returned to omsc.Therefore the exact cause of the reported event could not be conclusively determined at this time.A supplemental report will be submitted, if additional or significant information becomes available at a later time.

Event Description

Olympus medical systems corp.(omsc) was informed by the health professional that during a procedure of vocal fold augmentation using the subject device, the following event occurred.The device was used for the application of restylane vital light skinbooster which had a gel-like consistency.This agent was injected into the vocal cords by the device via the endoscope.The agent was not the entire intended amount was injected, but was at least a satisfactory amount.After the needle was stuck and it was not possible to inject the agent.The device can no longer be retracted into the sheath and the agent was sprayed out from the handle.The same product was used to attempt to complete the procedure.There was no patient injury reported.The multiple attempts to insert the needle through the endoscope significantly prolonged the outpatient procedure and resulted in significantly more gagging for the patient due to the bronchoscopic manipulations.However, no serious deterioration of the patient occurred.The device was not damaged.

Manufacturer Narrative

This is a supplemental report to provide additional information.The subject device and three un-used devices were returned to olympus medical systems corp.(omsc) for evaluation.The needle was extending from the distal end of the tube when it was arrived for investigation.The needle could not be retracted into the tube when the slider was pulled.During injection, the fluid was leaking from the handle.The fluid did not come out of the distal end of the needle.When the handle was disassembled, it was found that the needle tube was detached from the handle section.Also, the needle tube presented compressive buckling.No abnormalities detected about the unused devices.The manufacturing record was reviewed and found no irregularities.Based on the investigation result, a likely mechanism causing the reported event might be the following: 1.The frictional resistance between the outer tube and the needle tube increased due to the following factors: *an inspection of operation of the device was performed with the tube was being coiled, or the insertion portion was being bent excessively.*the slider was inserted abruptly.*angle of the endoscope *shape of the insertion portion of the endoscope 2.The frictional resistance between the outer tube and the needle tube became large.This caused the compressive buckling of the tube while the needle was extending from the distal end of the tube.3.Due to compression buckling of the needle tube, liquid could not be injected.Also, the pressure of the liquid injection was applied to the needle tube connection.4.The needle tube was detached from the handle section due to the pressure of the liquid injection 5.Due to the detachment of the needle tube, the fluid leaked from the handle area during injection.Also, the needle could not be retracted into the outer tube.Nm-401l series undergo 100% inspection for appearance, needle operation and injection during production process.Therefore, it can be inferred that handling the device at the facility might have contributed to the reported event.The above device handling has warned in the instruction manual.

• 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
• MDR Report Key: 11730456
• MDR Text Key: 247882332
• Report Number: 8010047-2021-05457
• Device Sequence Number: 1
• Product Code: FBK
• UDI-Device Identifier: 04953170382338
• UDI-Public: 04953170382338
• Combination Product (y/n): N
• PMA/PMN Number: K902736
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 06/11/2021

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: Other
• Device Model Number: NM-401L-0423
• Device Lot Number: K0Z08
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/25/2021
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/09/2021
• Initial Date FDA Received: 04/27/2021
• Supplement Dates Manufacturer Received: 05/25/2021
• Supplement Dates FDA Received: 06/10/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1