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

Model Number HX-400U-30

Device Problem Separation Failure (2547)

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

Event Date 06/22/2022

Event Type  malfunction  

Event Description

The customer reported the loop of the subject device could not be released on the pedicle of a polyp during a polypectomy procedure.The loop could be closed but dropping it was not possible.The procedure was completed after a delay of approximately ten minutes.There was no effect on the patient due to the event.The subject device was sent to olympus for evaluation.During inspection and testing, the loop could not be detached.

Manufacturer Narrative

During inspection and testing, the loop could not be detached.Upon receipt, the loop was connected to the subject device and there was no damage to the handle.The loop could tie up a cylindrical object, however, the loop could not be released from the hook when the slider was pushed.The connection between the loop and the hook was inspected by stretching the coil sheath.The rear end of the loop was not properly connected to the hook and the loop was caught between the coil sheath and the hook.The loop was pulled in the direction of the distal end, however, the loop could not be withdrawn from the coil sheath.Inspection of the appearance of the loop found deformation in the rear end of the loop.The hook did not appear to have any abnormalities such as deformation or bending.A review of the device history record found no deviations that could have caused or contributed to the failure to detach.The device shipped according to specifications.Based on the results of the legal manufacturer's investigation, it is likely the loop could not be removed from the polyp because the loop was surrounding body tissue, and it was temporarily ligated by pulling the slider.The tube sheath was then pushed out, and the distal end of the coil sheath went into the tube sheath.An attempt was then made to detach the loop and the loop detached from the hook in the tube.While the hook was extending from the coil sheath, the loop moved towards the proximal side and went into the coil sheath.The hook was then pulled which caused the hook and the loop to retract into the coil sheath together.As a result, the loop and the hook got stuck inside the coil and could not move.Since the loop and the hook got stuck together inside the coil, the loop did not detach when the slider was pulled.However, a definitive root cause of the reported issue could not be identified.The device's instruction manual provides the following warning, which may help to prevent the issue: "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 ¿emergency treatment¿ and as shown ¿equipment to be used in an emergency¿ 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 ¿emergency treatment¿ and as shown ¿equipment to be used in an emergency¿ 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 ¿emergency treatment¿ and as shown ¿equipment to be used in an emergency¿ 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.Investigation activities have been opened to manage the actions related to this issue and any required mdr reporting.

• 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: 15616170
• MDR Text Key: 307196476
• Report Number: 9614641-2022-00489
• Device Sequence Number: 1
• Product Code: FHN
• UDI-Device Identifier: 04953170368615
• UDI-Public: 04953170368615
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: Other
• Type of Report: Initial
• Report Date: 10/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/17/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: HX-400U-30
• Device Lot Number: 16V
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/11/2022
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/23/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/28/2021
• 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