MAUDE Adverse Event Report: AOMORI OLYMPUS CO., LTD. SINGLE USE LOOP CUTTER FS-410

Model Number FS-410L

Device Problem Failure to Cut (2587)

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

Event Date 03/22/2023

Event Type  malfunction  

Manufacturer Narrative

E1: nagano prefectural welfare federation of agricultural cooperatives saku general hospital saku medical center the device was not returned for evaluation and investigation.A review of the device history record (dhr) found no deviations that could have caused or contributed to the thread catching, and the slider stopping.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 defective event was caused due to an attempt was possibly made to cut the suture, without the suture being on both sides of the loop hanger.This might have caused the suture to be caught in the cutter storage part.As a result, the suture could not be cut.There were no abnormalities observed in the insertion portion.The occurrence of the reported problem can be prevented by adhering to the instructions for use (ifu) which states the following: (1) due to the positioning relationship between the loop and loop hanger, or the suture and loop hanger, this instrument may become unable to be withdrawn from the patient body when the loop or the suture is caught by the cutter storage part (2) if this instrument cannot be withdrawn from the patient body because the loop or the suture is caught by the distal end (3) before use, prepare and inspect the instrument (4) position the loop or the suture on both edges of the loop hanger so as to make it as plumb as possible with respect to the distal end and cut it (5) do not cut the loop or the suture unless you have a clear endoscopic field of view (6) if this instrument cannot be withdrawn from the patient body, make a judgment from the specialist¿s view.Olympus will continue to monitor field performance for this device.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation or if any additional information is provided by the user facility.

Event Description

The customer reported to olympus that, after suturing in a stomach case (ehs: endoscopic hand-sewn suturing method), when trying to cut the thread using the single use loop cutter fs-410, the thread caught, and the slider stopped moving.The customer switched to a hook knife to cut the thread and the endoscopic submucosal dissection (esd) procedure was completed.There was no report of patient or user harm associated with the event.

Manufacturer Narrative

This report is being supplemented to provide a correction for information inadvertently missed on the initial report.The device evaluation found the suture thread was caught in the cutter housing.The action of the slider was smooth and there was no abnormality such as buckling in the insertion site.There were no missing areas, nicks or chipping in the blade of the cutter.The suture was cut without any problems.The occurrence of the reported problem can be prevented by adhering to the instructions for use (ifu) which states the following: "due to the positioning relationship between the loop and loop hanger, or the suture and loop hanger, this instrument may become unable to be withdrawn from the patient body when the loop or the suture is caught by the cutter storage part.Have a full understanding of the potential of the loop or the suture caught at the distal end before using this instrument.Depending on the positional relationship between the loop and the loop receiving part, or the suture and the loop receiving part, the loop or suture may get caught in the cutter housing and be unable to be pulled out from the body.When using this product, please fully understand the possibility of loops or suture getting caught.If this instrument cannot be withdrawn from the patient body because the loop or the suture is caught by the distal end, refer to chapter 12, ¿emergency treatment¿.If a loop or suture gets caught in the tip and you cannot pull this product out of your body, see "12 emergency procedures." before use, prepare and inspect the instrument as instructed below.Should any irregularity be observed, do not use the instrument; use a spare instead.Damage or irregularity may compromise patient or user safety, such as punctures, hemorrhages, or mucous membrane damage, and may result in more severe equipment damage.Be sure to perform the following preparations and inspections before use.If any abnormality is suspected, do not use and use a spare product.Using this product with suspected abnormalities may not only cause it to malfunction, but may also lead to perforation, major bleeding, damage to mucous membranes, etc., as well as damage to the device or reduced functionality.Position the loop or the suture on both edges of the loop hanger so as to make it as plumb as possible with respect to the distal end and cut it (see figure 3 (a)).Do not try to cut the loop or a suture that is not positioned on both edges of the loop hanger (see figure 3 (b)).It may make cutting the loop or the suture impossible, or result in the loop or the suture getting caught in the cutter storage part of the instrument, which could make it difficult or impossible to remove from the patient.(see figure 3 (b), (c)) if this instrument cannot be withdrawn from the patient body because the loop or the suture is caught by the distal end, refer to chapter 12, ¿emergency treatment¿.Place the loop or suture on both sides of the loop receiver so that it is as perpendicular to the cutter as possible and cut (see fig.3(a)).If the loop or suture is not placed correctly, not only will the loop or suture not be cut, but the loop or suture may get caught in the cutter compartment and prevent the product from being removed from the body.(refer to fig.3 (b) and (c)) if the product cannot be pulled out from the body, refer to "12 emergency measures".Do not cut the loop or the suture unless you have a clear endoscopic field of view.This could cause the loop or the suture getting caught in the cutter storage part of the instrument, and it may become difficult to safely remove the instrument from the body.It may also cause patient injury, such as punctures, hemorrhages, or mucous membrane damage, or the endoscope and/or instrument damage.If this instrument cannot be withdrawn from the patient body because the loop or the suture is caught by the distal end, refer to chapter 12, ¿emergency treatment¿.Do not cut loops or sutures when the endoscope is not in sight.A loop or suture may get caught in the cutter compartment and prevent the product from being removed from the body.In addition, it may lead to perforation, heavy bleeding, mucous membrane damage, etc., and may lead to damage to the endoscope or this product.If the product cannot be pulled out from the body, refer to "12 emergency measures".If this instrument cannot be withdrawn from the patient body, make a judgment from the specialist¿s view.Forcible withdrawal could lead to bleeding or mucous membrane damage.If this product cannot be pulled out from the body, judge from a professional standpoint and take appropriate measures.Forcible withdrawal may lead to bleeding and mucous membrane damage.".

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation (h6/h10).Based on the results of the investigation, the root cause could not be determined as the reported event could not be reproduced.During evaluation, replication testing was carried out to see if the reported event could be replicated (the suture was caught in the cutter and the cutter did not open).The evaluator performed the following; 1.Cut the suture while the mucous membrane of the organ (pork stomach) was attached to the tip of the fs-410 and the suture.2.With the mucous membrane of the organ (pig stomach) attached to the tip of the fs-410 and the suture, the tip of fs-410 was rotated counterclockwise and then the suture was cut.3.Cut the organ (pig stomach) mucous membrane with oil (pork fat) while it was attached to the tip of the fs-410 and the suture.Under all conditions, the suture could be cut, and the cutter could be opened and closed.The state where the reported event occurred could not be replicated.Based on the results of reproduction studies, it is speculated that the phenomenon occurred due to the following; 1.When the suture was cut part of the suture got caught in the gap between the cutter and the cutter receiver.2.It became impossible to open the cutter because part of the suture was caught.3.Since the cutter could not be opened, the suture thread that had been cut was stuck and could not be removed.Olympus will continue to monitor field performance for this device.

• Brand Name: SINGLE USE LOOP CUTTER FS-410
• Type of Device: LOOP CUTTER
• 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: 16791803
• MDR Text Key: 313800066
• Report Number: 9614641-2023-00547
• Device Sequence Number: 1
• Product Code: PTS
• UDI-Device Identifier: 04953170401039
• UDI-Public: 04953170401039
• 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: Foreign,Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 08/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/21/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FS-410L
• Device Lot Number: 24K
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/03/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/25/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/21/2022
• 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