MAUDE Adverse Event Report: AOMORI OLYMPUS CO., LTD. SINGLE USE LIGATING DEVICE

Model Number HX-400U-30

Device Problems Material Protrusion/Extrusion (2979); Material Twisted/Bent (2981)

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

Event Date 07/28/2023

Event Type  malfunction  

Event Description

The customer reported the single use ligating device was used for a therapeutic polypectomy procedure.After temporary fastening, which was not the original usage, the main ligation was performed by the staff.The customer noted that after closing the stemmed polyp by advancing the ligating device tube sheath forward (without the yellow holding section on the handle side, doing the opposite movement), this was the act of closing the handle slider while pulling the tube sheath toward the handle while tying off the stem.This was the routine procedure at the facility.The handle wire of the operation part was then protruded and bent.No other issues occurred and the ligation, opening, closing and release were performed without any problems.No parts were detached and the device was used to completed the procedure.The device was discarded after the procedure.The customer noted the ligating device was used with a balloon long scope from another manufacturer.There was no reported patient harm or impact due to this event.

Manufacturer Narrative

The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation or if any additional information is provided by the user facility.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.The device history record was unable to be reviewed for this device since the serial number was not provided.However, olympus only releases products to market that meet all manufacturing specifications and final product release criteria.Based on the results of the investigation, a likely mechanism causing the reported event might be the following: 1) the sheath was bent near the handle.2) the operating wire could not move since sliding resistance between the sheath and the operating wire increased.3) the operating pipe deformed since the slider was forcefully operated.4) since the bending of the sheath was resolved after that, the slider was able to work without any problems.However, a specific root cause cannot be identified.The event can be prevented by following the instructions for use which state: ·"do not strike or crush the coil sheath during operation.Doing so can damage the distal end of the coil sheath, which could make it impossible to detach the loop after ligation.In this case, refer to section 12, ¿emergency treatment¿ and as shown ¿equipment to be used in an emergency¿ on page 3 in this manual." ·"straighten out the portion of the instrument that extends from the biopsy valve." olympus will continue to monitor field performance for this device.

• Brand Name: SINGLE USE LIGATING DEVICE
• Type of Device: SINGLE USE LIGATING DEVICE
• 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
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 17557393
• MDR Text Key: 321343900
• Report Number: 9614641-2023-01171
• Device Sequence Number: 1
• Product Code: FHN
• UDI-Device Identifier: 04953170194641
• UDI-Public: 04953170194641
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 09/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/16/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: HX-400U-30
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/11/2023
• 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