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

Model Number HX-400U-30

Device Problem Lack of Effect (4065)

Patient Problems Hemorrhage/Bleeding (1888); Unspecified Tissue Injury (4559)

Event Date 09/27/2023

Event Type  Injury  

Event Description

The customer reported to olympus that during polypectomy when an indwelling snare was applied and ligated, the base of the polyp was torn.The procedure was completed by stopping the bleeding with a clip.The device was inspected before use with no abnormality observed.There were no reports of further patient or user harm associated with this event.

Manufacturer Narrative

The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation or when additional information becomes available.

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.Based on the results of the investigation, since the device was not returned for evaluation, no abnormalities were confirmed.Therefore, the root cause of the event could not be determined.However, the event was likely caused by the following: 1a person assisting with the procedure pulled the slider too much, and the polyp was mechanically resected.The polyp resection was performed mechanically, which caused the bleeding.The event can be detected/prevented by following the instructions for use (ifu) which state: ¿the operator of this instrument must be physician or medical personnel under the supervision of a physician and must have received sufficient training in clinical endoscopic technique.This manual, therefore, does not explain or discuss clinical endoscopic procedures.¿ ¿operation of this instrument is based on the assumption that open surgery is possible as an emergency measure if the loop cannot be detached from the instrument or if any other unexpected circumstance takes place.In this case, refer to section 12, ¿emergency treatment¿ and as shown ¿equipment to be used in an emergency¿ in this manual.¿ ¿use this instrument in an environment equipped to accommodate open surgery and have the hospitalization plan prepared in case any problem occurs that may not be resolved endoscopically.¿ ¿never use excessive force to operate the instrument.This could damage the instrument.¿ ¿do not insert the instrument into the endoscope unless you have a clear endoscopic field of view.If you cannot see the distal end of the insertion portion in the endoscopic field of view, do not use it.This could cause patient injuries, such as punctures, hemorrhages, or mucous membrane damage.It may also damage the endoscope and/or instrument.¿ ¿do not withdraw the instrument or change the angulation of the endoscope before the loop is detached from the instrument.Doing so may tear tissue inside the body cavity, resulting in patient injury, such as punctures, hemorrhages, or mucous membrane damage.¿ ¿do not apply unnecessary force to the loop when ligating tissue during the procedure.Excessive force applied to the loop could cut the surrounding body cavity tissue, resulting in patient injury, such as hemorrhages or mucous membrane damage.It may also damage the endoscope and/or instrument.¿ this supplemental report includes a correction to b1 and g2.¿product problem¿ was inadvertently selected on the initial medwatch.This has been corrected to "adverse event" only, as there was no reportable device malfunction.Also, information has been added to g2 that was inadvertently not included on the initial medwatch.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: 17919966
• MDR Text Key: 325491148
• Report Number: 9614641-2023-01512
• Device Sequence Number: 1
• Product Code: FHN
• UDI-Device Identifier: 04953170194641
• UDI-Public: 04953170194641
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: CLASS2-EXMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Company Representative,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 10/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/12/2023
• Is this an Adverse Event Report?: Yes
• 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: 10/23/2023
• 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
• Treatment: PCF-H290TI
• Patient Outcome(s): Other