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

Model Number FS-410U

Device Problem Entrapment of Device (1212)

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

Event Date 09/07/2023

Event Type  Injury  

Manufacturer Narrative

The device was not returned to olympus for evaluation.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation.

Event Description

The customer reported during a therapeutic gastroscopy procedure for a female, twenty-three year old patient they tried to cut the suture from the probe with single use loop cutter fs-410.The loop cutter did not cut the suture so the customer tried to cut it with fs-5u-1 loop cutter.The reusable version model, fs-5u-1, became stuck while cutting and the customer was unable to release the jaws of the loop cutter.They cut the handle and retrieved the scope from the patient.The patient was transferred to another hospital with the loop cutter still hanging out of the patients mouth.A second endoscopic examination was performed and with light pulling force the clip with the suture thread was able to be removed.The customer later confirmed there was no additional harm to the patient and the current status of the patient is good.A feeding probe was placed to ensure the patient receives sufficient intake.The jejunal extension was clipped to the mucosa with a suture and the suture became stuck in the fs-5u-1 loop cutter.The loop cutter with suture and extension have been removed.This event is reported under the following related patient identifiers: (b)(6) represents single use loop cutter fs-410.(b)(6) represents loop cutter fs-5u-1.This medwatch report is for patient identifier (b)(6) that represents single use loop cutter fs-410.

Manufacturer Narrative

This supplemental report is being submitted to provide a correction to the previous mdr submission.Although the specific device lot number is unknown, the device history record (dhr) of lots 29k-38k (for the past year) were reviewed.No abnormalities were detected in the dhr for the reviewed lots relating to this reported phenomenon.This supplemental report includes a correction to e1 and h6 (type of investigation and investigation findings) to provide information that was inadvertently not included in the previous submission.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.The device history record was unable to be reviewed for this device since the serial number was not provided.However, olympus only releases products to market that meet all manufacturing specifications and final product release criteria.Based on the results of the investigation and investigation results of the similar complaint in the past, it is likely an attempt was 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 cutter could not be opened.However, the subject device was not returned and the root cause of the suggested event could not be identified.The event can be prevented by following the instructions for use which state: 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.Do not try to cut the loop or a suture that is not positioned on both edges of the loop hanger.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¿.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.Olympus will continue to monitor field performance for this device.

Manufacturer Narrative

This supplemental report is being submitted to provide additional information from the instructions for use (ifu).The event can be detected/prevented by following the ifu which state: "do not use the instrument to cut any objects other than the surplus of olympus loop (maj-254, maj-339, maj-340, hx-400) or the designated suture.If anything other than the surplus of the loop or the designated suture is cut, the cutter may be damaged and unable to perform properly, the cut object may be caught in the cutter storage part of the instrument, and it may become difficult to safely remove the instrument from the body.Such objects other than the surplus of loop may include stent, stent wire, and loop stoppers.In this case, refer to chapter 12, 'emergency treatment.".

• 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: 17856605
• MDR Text Key: 324769058
• Report Number: 9614641-2023-01447
• Device Sequence Number: 1
• Product Code: PTS
• UDI-Device Identifier: 04953170401053
• UDI-Public: 04953170401053
• Combination Product (y/n): N
• Reporter Country Code: NL
• 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,Followup,Followup
• Report Date: 12/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/02/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FS-410U
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/06/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: LOOP CUTTER FS-5U-1
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 23 YR
• Patient Sex: Female