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

Model Number FS-410U

Device Problem Mechanical Problem (1384)

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

Event Date 09/29/2022

Event Type  malfunction  

Event Description

It was reported when the suture thread was cut, the thread could not be cut once the forceps were closed by pinching the thread , and the forceps could not be opened even if the slider was moved while the thread was being bitten as described by the reporter.The user pulled the forceps and the thread was cut and the procedure was completed.According to the reporter, after suturing the first lesion, the thread was cut without any problems.According to the reporter, the issue occurred when the thread was cut for the second lesion.The intended endoscopic hand-suturing (ehs) therapeutic procedure was completed using the same set of equipment with no patient harm or impact reported.No user injury was reported.The device was used with vlock.

Manufacturer Narrative

Initial reporter name and address:: address- (b)(4) hospital.The model number was fs-410u.The lot number was 27k with supplementary information number of ¿12¿.Device inspection noted the suture was not caught in the cutter storage part.When pushing and pulling the slider, the cutter opened and closed smoothly.No abnormalities such as buckling were observed in the insertion portion.There were no missing areas and nicks in the blade of the cutter.Testing performed ¿ (an attempt was made ) to cut the nylon thread by using the subject device (fs-410u).The subject device was able to cut without any problems.A review of the device history record (dhr) found no deviations that could have caused or contributed to the reported device problem.No abnormalities were noted in the dhr.Review of the records includes the following : process inspection sheet, quality inspection sheet, nonconforming product report, a review of the device history record found the subject device was shipped in accordance with specifications.Instruction for use (ifu): the instruction manual (rk0372 rev02) , contains the following descriptions, and it warns against this 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relationship between the loop and loop hanger, or the suture and loop hanger, this instrument may become unable to be withdrawn from the patient body when the loop or the suture is caught by the cutter storage part.Have a full understanding of the potential of the loop or the suture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.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¿.Cause: 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.Olympus will continue to monitor complaints 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 Contact: masaharu hirose ; 2-248-1 okkonoki; kuroishi-shi, aomori 036-0-357 ; JA 036-0357 ; 426422891
• MDR Report Key: 15656829
• MDR Text Key: 307105900
• Report Number: 9614641-2022-00528
• 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
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/24/2022
• 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: 27K
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/05/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/29/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/12/2022
• 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: VLOCK
• Patient Sex: Male