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

Model Number FS-410U

Device Problem Failure to Cut (2587)

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

Event Date 07/25/2022

Event Type  malfunction  

Manufacturer Narrative

The subject device was returned to olympus for evaluation.During inspection and testing, it was observed the suture was caught in the cutter storage part.The operating slider would not open or close the cutter.No abnormalities such as buckling were observed in the insertion portion of the device.The suture was able to be removed, as the cutter was moved using tweezers.The length of the suture that was caught in the cutter storage part was approximately 5mm.After the suture was removed from the cutter storage part, when pushing and pulling the slider, the cutter opened and closed smoothly.There were no missing areas or nicks in the blade of the cutter.An attempt was made to cut the suture by using the subject device, and the suture was able to be cut without any problems.A review of the device history record found no deviations that could have caused or contributed to the reported issue.The device met all specifications at the time of shipment.Based on the results of the legal manufacturer's investigation, it is possible an attempt was made to cut the suture without the suture being on both sides of the loop hanger.This may have caused the suture to be caught in the cutter storage part.As a result, the suture could not be cut.However, a definitive root cause could not be determined.The device's instructions for use provides the following warnings regarding the suggested event: "·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relationship between the loop and loop hanger, or the suture and loop hanger, this instrument may become unable to be withdrawn from the patient body when the loop or the suture is caught by the cutter storage part.Have a full understanding of the potential of the loop or the suture caught at the distal end before using this instrument.If this instrument cannot be withdrawn from the patient body because the loop or the suture is caught by the distal end, refer to chapter 12, ¿emergency treatment¿.Position the loop or the suture on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¿." olympus will continue to monitor field performance for this device.

Event Description

The customer reported that after a rectal endoscopic hand suturing (ehs) procedure, when the subject device was used to cut the suture (needle thread) for the first time, the thread got entangled in the loop cutter and could not be cut.The loop cutter could not be removed from the endoscope.Since it was a rectal case, it was removed while passing through an endoscope outside the body, and the thread was removed outside the body.The procedure was completed using another fs-410u.No health hazards occurred.Additional information was later received regarding the reported event.The fs-410u was removed together with the endoscope.The thread (suture) has a length that extends outside of the body, and the thread is excised outside the body.The model number of the endoscope was not known.

• 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 Contact: masaharu hirose ; 2-248-1 okkonoki; kuroishi-shi, aomori 036-0-357 ; JA 036-0357 ; 426422891
• MDR Report Key: 15329147
• MDR Text Key: 305422922
• Report Number: 9614641-2022-00240
• 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,Health Professional,User Facility,Company Representative,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 08/31/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/31/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FS-410U
• Device Lot Number: 24K
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/16/2022
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/02/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/25/2022
• 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
• Treatment: MEDTRONIC VLOCL0804 SUTURE