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

Model Number HX-400U-30

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Unspecified Tissue Injury (4559)

Event Date 12/05/2022

Event Type  Injury  

Event Description

The customer reported to olympus that while using a single use ligating device, during ligation of a polyp, the mucous membrane was torn apart.Hemostasis was performed on the patient with a clip and the procedure was completed.The patient was under sedation but no prolongation of procedure occurred.Additional information has been requested.

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 supplemental report is being submitted to provide additional information obtained from the customer regarding the reported event.

Event Description

Additional information reported that the procedure being performed was a polypectomy.The amount of blood loss was unknown.It was also stated that there were no additional interventions required, and the patient healed and recovered.

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, a likely mechanism that caused the reported event is as follows: 1.The polyp was surrounded with the loop.2.The polyp was ligated with the loop by pulling the slider.3.The slider was pulled excessively.This caused the polyp to break and bleed.The event can be detected/prevented by following the instructions for use (ifu) which state: ¿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.¿ 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: 16060400
• MDR Text Key: 306254672
• Report Number: 9614641-2022-00856
• Device Sequence Number: 1
• Product Code: FHN
• 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,User Facility,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 05/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: HX-400U-30
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/07/2023
• 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: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian