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

Model Number FS-410U

Device Problem Difficult to Remove (1528)

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

Event Date 06/30/2023

Event Type  Injury  

Event Description

The customer reported to olympus that during suturing after endoscopic submucosal dissection (esd), the tooth caught the thread and it could not be removed.The thread was cut by inserting grasping forceps from the opposite side and removing the thread.The procedure was completed with no reports of patient or user harm associated with this event.

Manufacturer Narrative

This device has been returned for evaluation and confirmed the allegation.The suture was not caught in the cutter storage part.No abnormalities such as buckling were observed in the insertion portion.Operating the slider was smooth.There were no missing areas and nicks in the blade of the cutter.An attempt was made to cut the suture by using the subject device.The suture was able to cut without problems.A review of the device history record found no deviations that could have caused or contributed to the reported issue.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relationship between the loop and loop hanger, or the suture and loop hanger, this instrument may become unable to be withdrawn from the patient body when the loop or the suture is caught by the cutter storage part.Have a full understanding of the potential of the loop or the suture caught at the distal end before using this instrument.If this instrument cannot be withdrawn from the patient body because the loop or the suture is caught by the distal end, refer to chapter 12, ¿emergency treatment¿.Before use, prepare and inspect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.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¿.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¿.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.Although the root cause of this event could not be determined, 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 updated investigation and correction to the initial with information inadvertently left out.Additionally, to provide a correction to the initial h10 evaluation confirmation.The initial h10 report confirmed the customers allegation.However, the customer's complaint/reportable malfunction was not confirmed.Based on the results of the investigation, it is possible the phenomenon's "tooth caught the thread and could not be removed so it was cut" and "loop cutter stuck in patient body but could be removed by following instructions manual" an attempt was possibly made to cut the suture without the suture being on both sides of the loop hanger.This could have caused the suture to be caught in the cutter storage part.As a result, the suture could not be detached from fs-410u.However, the root cause of the phenomenon's could not be determined.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: 17410075
• MDR Text Key: 319968701
• Report Number: 9614641-2023-01041
• Device Sequence Number: 1
• Product Code: PTS
• UDI-Device Identifier: 04953170401053
• UDI-Public: 04953170401053
• 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,User Facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 09/18/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/27/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FS-410U
• Device Lot Number: 2XK
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/06/2023
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/01/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/26/2022
• 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
• Patient Outcome(s): Required Intervention
• Patient Sex: Male
• Patient Race: Asian