MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. 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 05/24/2022

Event Type  malfunction  

Manufacturer Narrative

The device was returned, however an initial evaluation has not yet been conducted by olympus and the investigation is still ongoing.If additional information becomes available prior to the conclusion of the investigation, a supplemental report will be filed.

Event Description

The customer reported that during an endoscopic polypectomy procedure, his olympus single-use ligating device was having difficulty detaching the polyp loop.According to the initial reporter, the loop was caught on the polyp, tied up, and could not be released.Reportedly, after cutting and removing the wire using a loop cutter, the staff changed the subject device out for a new one and completed the procedure without any harm to the patient.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the device evaluation and the legal manufacturer's final investigation.The device was evaluated where the tube sheath was separated from the main body.The tube sheath was severed at 2260 mm from its distal end.The tube sheath was missing approximately 80-100 mm containing the tube joint.The coil sheath was severed approximately 2160 mm from distal end of the insertion portion.The loop snare was in the distal end of the tube sheath.The loop stopper was moved to the distal side of the loop.The proximal side of the loop was deformed.The operating pipe of the handle was bent and broken.The outer diameter of the operating pipe was measured and the result indicated no abnormalities.The hook was not deformed, and not broken.Other abnormalities that could lead to the reported event were not confirmed.A review of the device history record found no deviations that could have caused or contributed to the reported issue.Based on the investigation result and the replication testing results in the past, a likely mechanism causing the reported event (the loop could not be detached from the hook.The operating pipe was broken.) is likely the following: 1.The proximal side of the loop was retracted into the coil sheath.2.The loop was caught between the coil sheath and the hook temporarily.3.Since the slider did not move, the loop could not detach from the coil sheath.4.The slider was forcefully operated where the operating pipe bent and broke.The details of above mechanism were the following: 1) the loop was surrounding the body tissue, and it was temporarily ligated by pulling the slider.2) the tube sheath was pushed out, and the distal end of the coil sheath went into the tube sheath.3) an attempt was made to detach the loop in state of above description therefore, the loop detached from the hook in the tube.4) while the hook was extending from the coil sheath, the loop moved towards the proximal side and went into the coil sheath.5) the hook was pulled.This 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.6) since the loop and the hook got stuck together inside the coil, the loop did not detach when the slider was pulled.7) the slider was continuously pulled back and forth in state of above description 6.This applied a force to the operating pipe causing it to bend and break.Or the slider was operated with the coil sheath near the operating portion bent.This applied a force causing it to bend and break.Based on the result of the device evaluation, it is likely that the proximal side of the tube sheath was severed using a sharp tool for an emergency countermeasure.The following is included in the device instructions for use (ifu): "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.

• Brand Name: SINGLE USE LIGATING DEVICE
• Type of Device: SINGLE USE LIGATING DEVICE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• Manufacturer Contact: kazutaka matsumoto ; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8-507 ; JA 192-8507 ; 426425177
• MDR Report Key: 14753750
• MDR Text Key: 294388638
• Report Number: 8010047-2022-10406
• Device Sequence Number: 1
• Product Code: FHN
• UDI-Device Identifier: 04953170368615
• UDI-Public: 04953170368615
• 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,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 08/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/21/2022
• 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: 14K
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/30/2022
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/22/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/12/2021
• 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