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

Model Number HX-400U-30

Device Problem Material Separation (1562)

Patient Problem Foreign Body In Patient (2687)

Event Date 11/09/2022

Event Type  Injury  

Event Description

The customer reports during an endoscopic submucosal dissection (esd) procedure using a single use ligating device, the surgeon wanted to perform purse string suture on the patient due to the large surgical wound.After using several titanium clips, it was found that the connection part between the handle end and the snare loop was broken and fell into the patient.The operator failed to find the detached part, so was unable take it out.A new device was opened to suture again, so that the operation could be completed.There was no injury to the patient.

Manufacturer Narrative

The device referenced in this report was not returned to olympus for evaluation.The definitive cause of the user's experience cannot be determined at this time.The investigation is ongoing.This report will be updated upon completion of the investigation or upon receipt of additional relevant information.

Event Description

The following additional information was received: it was confirmed that there were no other defects other than difficulty releasing the loop.Also, no saline solution or chemicals were used before or during the procedure.

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.It has been over 1 year since the subject device was manufactured.Based on the results of the investigation, although the root cause could not be determined, it is likely that the event occurred because the hook broke when the slider was pulled while closing the loop.The mechanism causing the breakage of the hook was likely due to the following factors: 1)the protrusion of the hook corroded due to foreign matter adhesion.2)force was applied to the hook when the tissue was snared.This supplemental report includes information added to b5, d4 (lot number), and h4.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: 16033096
• MDR Text Key: 305977098
• Report Number: 9614641-2022-00840
• Device Sequence Number: 1
• Product Code: FHN
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: EXMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/02/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: HX-400U-30
• Device Lot Number: 19K07
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/04/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/07/2021
• 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
• Patient Outcome(s): Other