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

Model Number HX-400U-30

Device Problem Difficult or Delayed Positioning (1157)

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

Event Date 09/26/2023

Event Type  Injury  

Manufacturer Narrative

The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation.

Event Description

A customer reported to olympus that during a therapeutic polyp ligation, the single use ligating device (polyloop) would not release after it got stuck in the metal sheath upon deployment.The physician could see the small metal hook released from itself but the polyloop was stuck deep in the sheath.It was stated that it felt like the handle also got stuck and couldn't move back and forth when the hook released.The physician had to cut the device with a wire cutter and then went back in to cut the tail of the polyloop with endoscopic scissors.Of note, the device had been inspected prior to use.The physician felt that this was a risky turn out and could have perforated the bowel; no perforation was reported however.A delay was reported but the timeframe was not given.After the intervention procedure was done, the procedure was completed.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation and device evaluation.Additionally, to provide updates to fields h3 and h4.The device was returned to olympus for inspection, and the customer's complaint/reportable malfunction was confirmed.The evaluation confirmed the following: the coil sheath was severed at approximately 2240 mm from its distal end.The tube sheath was severed at approximately 2245 mm from its distal end.The broken portion of insertion portion side presented a shape that was possibly severed by a tool.The broken portion of handle side presented a shape that was possibly severed by a tool.The operating pipe of the slider was buckled.The operating pipe was broken and removed from the coil sheath.The broken portion of the operating pipe had the characteristic trace that appear in ductile fracture.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, it is likely the polyp could not release which led to cutting the device with wire cutter and went back in to cut the tail of the polyp with endoscopic scissors occurred due to one of the following mechanisms: 1) the loop was surrounding the body tissue.2) the tube sheath was pushed out, and the body tissue was temporarily ligated by using the distal end of the tube sheath.3) the loop was tightened by pulling the slider.4) the slider was pushed while the distal end of coil sheath did not extend from the tube sheath.Therefore, the loop detached from the hook in the tube sheath.5) while the hook was extending from the coil sheath, the loop moved towards the proximal side and went into the coil sheath.6) 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.7) since the loop and the hook got stuck together inside the coil, the loop did not detach when the slider was pulled.8) the slider was forcefully operated in state of ¿7¿ description causing the operation pipe of the slider to deform.Additionally, it is possible that the sheath near the handle was severed by a tool, to remove the device from an endoscope.However, the root cause of the suggested event could not be identified.The event can be prevented by following the instructions for use which state: "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, ¿emergency treatment¿ and as shown ¿equipment to be used in an emergency." "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, ¿emergency treatment¿ and as shown ¿equipment to be used in an emergency.¿ "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, ¿emergency treatment¿ and as shown ¿equipment to be used in an emergency¿ 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: 17975282
• MDR Text Key: 326151161
• Report Number: 9614641-2023-01565
• Device Sequence Number: 1
• Product Code: FHN
• UDI-Device Identifier: 04953170368615
• UDI-Public: 04953170368615
• Combination Product (y/n): N
• Reporter Country Code: NZ
• 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
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 02/09/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/20/2023
• 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: 09V
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/11/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/08/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/03/2020
• 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): Required Intervention