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

Model Number HX-400U-30

Device Problem Mechanical Problem (1384)

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

Event Date 06/27/2022

Event Type  malfunction  

Manufacturer Narrative

The subject device was returned to olympus for evaluation and the investigation is in process.During inspection of the returned device, the following was observed: the lid of the handle where the lot number is displayed was removed and was not returned, so the lot number was unknown.The coil sheath and tube sheath were cut near the tip of the operation part.Only the disassembled operator side was returned, and the remaining insertion side was not.The operation pipe in the operation section was broken.The broken part of the coil sheath showed a fractured shape that looked like it had been cut by a tool.Since the insertion part was not returned, abnormalities that could have led to the event could not be confirmed.The investigation is ongoing; therefore, the root cause of the reported event cannot be determined at this time.If additional information becomes available, this report will be supplemented accordingly.

Event Description

A nurse at the user facility reported that during an endoscopic mucosal resection (emr) procedure, when the doctor tried to temporarily tighten the polyp with an indwelling snare (subject device) at the time of the emr, the tissue was pulled into the sheath and became incarcerated.The doctor cut the treatment tool (subject device) outside the body to release the tissue, and removed the endoscope and the treatment tool.The emr procedure was completed with no patient or user injury.

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 (dhr) found no deviations that could have caused or contributed to the coil sheath and tube sheath that were severed near the distal end of the handle.The dhr confirmed that the subject device was shipped in accordance with the specifications.A definitive root cause for this issue was not established.However, it is probable that the issue occurred because the proximate side of the loop was temporarily retracted into the coil sheath, and the loop was caught in between the coil sheath and the hook.This prevented the slider from moving, and the loop could not be detached from the coil sheath.Under these circumstances, the slider was forcefully operated.As a result, the operating pipe was bent/broken.The occurrence of the reported problem can be prevented by adhering to the instructions for use (ifu) which states the following: ¿·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.·do not remove the loop from the hook while the coil sheath is not extended from the tube sheath.Otherwise, the loop may be tangled with the hook and become impossible to be removed.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.·do not hold the loop with the distal end of the tube sheath while the loop is surrounding the tissue.Otherwise, when the tissue is ligated, the loop may be detached from the hook in the tube sheath and tangled with the hook.That may make the loop impossible to be removed.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.·never use excessive force to operate the instrument.This could damage the instrument.¿ olympus will continue to monitor field performance for this device.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation and additional information to the device evaluation.Please see updates to h10.During the device evaluation, it was confirmed that there was a kink in the metal part of the slider handle.However, it was determined that this defect is not considered severe enough to cause a potential adverse event.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 Contact: masaharu hirose ; 2-248-1 okkonoki; kuroishi-shi, aomori 036-0-357 ; JA 036-0357 ; 426422891
• MDR Report Key: 15113390
• MDR Text Key: 304232659
• Report Number: 9614641-2022-00044
• 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,Health Professional,User Facility,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date: 11/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/27/2022
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/11/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/26/2022
• Was Device Evaluated by Manufacturer?: Yes
• 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